ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Neoclarityn 5 mg film-coated tablets
2.
Each tablet contains 5 mg desloratadine.
For a full list of excipients, see section 6.1.
3.
Film-coated tablets
4.
Neoclarityn is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for
the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic
rhinitis) and urticaria (see section 5.1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents
12 through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than
4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than
4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
2
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial Neoclarityn taken concomitantly with alcohol did not potentiate the
performance impairing effects of alcohol (see section 5.1).
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in
breast-feeding women.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3 % of
patients in excess of those treated with placebo. The most frequent of adverse events reported in
excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial
with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was
headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving
placebo. Other undesirable effects reported very rarely during the post-marketing period are listed in
the following table.
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Elevations of liver enzymes, increased bilirubin,
hepatitis
Musculoskeletal and connective tissue disorders
Myalgia
General disorders
Hypersensitivity reactions (such as anaphylaxis,
angioedema, dyspnoea, pruritus, rash, and urticaria)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered
(nine times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
3
Hepatobiliary disorders
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H
1
-receptor
antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H
1
-
receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
in vitro
studies.
These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for
14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical
pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the
clinical dose) for ten days, no prolongation of QTc interval was seen.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose
ketoconazole and erythromycin interaction trials.
Desloratadine does not readily penetrate the central nervous system. In controlled clinical trials, at the
recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to
placebo. Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in
clinical trials. In a single dose study performed in adults, desloratadine 5 mg did not affect standard
measures of flight performance including exacerbation of subjective sleepiness or tasks related to
flying.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced
impairment in performance or increase in sleepiness. No significant differences were found in the
psychomotor test results between desloratadine and placebo groups, whether administered alone or
with alcohol.
In patients with allergic rhinitis, Neoclarityn was effective in relieving symptoms such as sneezing,
nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Neoclarityn effectively controlled symptoms for 24 hours. The efficacy of Neoclarityn tablets has not
been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less
than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of
symptoms for 4 days or more per week and for more than 4 weeks.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total
score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the
domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,
in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
4
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was
effective in relieving pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other
antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-
responsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was
observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with
placebo. Treatment with Neoclarityn also significantly reduced interference with sleep and daytime
function, as measured by a four-point scale used to assess these variables.
5.2 Pharmacokinetic properties
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the
terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was
consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The
bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general
seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of
desloratadine. This percentage may vary according to ethnic background. Maximum desloratadine
concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours. The safety profile of these subjects was not different from that of the general
population.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to
20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,
some interactions with other medicinal products can not be fully excluded. Desloratadine does not
inhibit CYP3A4
in vivo,
and
in vitro
studies have shown that the medicinal product does not inhibit
CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high
caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect
on the disposition of desloratadine.
5.3 Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with
desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The
lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and
loratadine.
5
6.
6.1 List of excipients
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
Tablet coating: film coat (containing lactose monohydrate, hypromellose, titanium dioxide,
macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax,
white wax.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package.
6.5 Nature and contents of container
Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride
(PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat
(product contact surface) which is heat sealed.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium
8.
EU/1/00/161/001-013
9.
Date of first authorisation: 15 January 2001
Date of last renewal: 15 January 2006
6
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
7
1.
Neoclarityn 5 mg oral lyophilisate
2.
Each dose of Neoclarityn oral lyophilisate contains 5 mg desloratadine.
For a full list of excipients, see section 6.1.
3.
Oral lyophilisate
4.
Neoclarityn is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Adults and adolescents (12 years of age and over): one dose of Neoclarityn oral lyophilisate placed in
the mouth once a day for the relief of symptoms associated with allergic rhinitis (including
intermittent and persistent allergic rhinitis) and urticaria (see section 5.1). Neoclarityn oral lyophilisate
disperses instantly and water or other liquid is not needed. The dose can be taken regardless of
mealtime.
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents
12 through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than
4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than
4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Immediately before use, the blister must be carefully peeled open and the dose of oral lyophilisate
removed without crushing it. The dose of oral lyophilisate is placed in the mouth where it will disperse
immediately. Water or other liquid is not needed to swallow the dose. The dose must be taken as soon
as the blister has been opened.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
8
This product contains aspartame 1.75 mg per dose. Aspartame is a source of phenylalanine, which
may be harmful for people with phenylketonuria.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in
breast-feeding women.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with Neoclarityn tablets were reported in
3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported
in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial
with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was
headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving
placebo. Other undesirable effects reported very rarely during the post-marketing period are listed in
the following table.
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Elevations of liver enzymes, increased bilirubin,
hepatitis
Musculoskeletal and connective tissue disorders
Myalgia
General disorders
Hypersensitivity reactions (such as anaphylaxis,
angioedema, dyspnoea, pruritus, rash, and urticaria)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
9
Hepatobiliary disorders
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine
times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H
1
-receptor
antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H
1
-
receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
in vitro
studies.
These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
In two single-dose trials, Neoclarityn oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data.
At the recommended dose, Neoclarityn oral lyophilisate was found to be bioequivalent to the
conventional tablet formulation of desloratadine. Therefore, the efficacy of Neoclarityn oral
lyophilisate is expected to be the same as with the Neoclarityn tablet formulation.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for
14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical
pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the
clinical dose) for ten days, no prolongation of QTc interval was seen.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose,
ketoconazole and erythromycin interaction trials.
Desloratadine does not readily penetrate the central nervous system. In clinical trials, at the
recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to
placebo. Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor
performance in clinical trials. In a single dose study performed in adults, desloratadine 5 mg did not
affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks
related to flying.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced
impairment in performance or increase in sleepiness. No significant differences were found in the
psychomotor test results between desloratadine and placebo groups, whether administered alone or
with alcohol.
In patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as
sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of
palate. Neoclarityn tablets effectively controlled symptoms for 24 hours. The efficacy of Neoclarityn
tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less
10
than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of
symptoms for 4 days or more per week and for more than 4 weeks.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total
score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the
domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,
in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was
effective in relieving pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other
antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-
responsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was
observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with
placebo. Treatment with Neoclarityn also significantly reduced interference with sleep and daytime
function, as measured by a four-point scale used to assess these variables.
5.2 Pharmacokinetic properties
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the
terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was
consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The
bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general
seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of
desloratadine. This percentage may vary according to ethnic background. Maximum desloratadine
concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours. The safety profile of these subjects was not different from that of the general
population.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to
20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,
some interactions with other medicinal products can not be fully excluded. Desloratadine does not
inhibit CYP3A4
in vivo,
and
in vitro
studies have shown that the medicinal product does not inhibit
CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
In single-dose crossover studies of Neoclarityn oral lyophilisate with Neoclarityn tablets, the
formulations were bioequivalent.
The presence of food has no relevant influence on AUC and C
max
of Neoclarityn oral lyophilisate
while the presence of food prolongs T
max
for desloratadine from 2.5 to 4 hours and T
max
for 3-OH-
desloratadine from 4 to 6 hours. In a separate study, grapefruit juice had no effect on the disposition of
desloratadine.
11
5.3 Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with
desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. No
significant local irritant effect was observed when the rapidly-dissolving form was tested in a hamster
cheek pouch mucous membrane irritation assay. The lack of carcinogenic potential was demonstrated
in studies conducted with desloratadine and loratadine.
6.
6.1 List of excipients
gelatin
mannitol
aspartame (E951)
polacrilin potassium
Dye Opatint Red (containing red iron oxide (E172) and hypromellose (E464))
flavour Tutti-Frutti
citric acid anhydrous
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
Neoclarityn oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with
foil lidding.
The materials of the blister consist of a polyvinyl chloride (PVC) film (product contact surface) with
an incorporated aluminium foil lidding coated with a vinyl heat seal coat (product contact surface)
which is heat sealed.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 doses of oral lyophilisate. Not all pack sizes may
be marketed.
6.6 Special precautions for disposal
No special requirements.
12
7.
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium
8.
EU/1/00/161/022-034
9.
Date of first authorisation: 15 January 2001
Date of last renewal: 15 January 2006
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
13
1.
Neoclarityn 2.5 mg orodispersible tablets
2.
Each dose of Neoclarityn orodispersible tablet contains 2.5 mg desloratadine.
For a full list of excipients, see section 6.1.
3.
Orodispersible Tablet
Light-red, flat-faced, round, speckled tablets, one side branded with “K”
4.
Neoclarityn is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Children 6 to 11 years of age: one 2.5 mg Neoclarityn orodispersible tablet placed in mouth once a day
for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent
allergic rhinitis) and urticaria (see section 5.1).
Adults and adolescents (12 years of age and over): two 2.5 mg Neoclarityn orodispersible tablets
placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including
intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
The dose can be taken regardless of mealtime.
There is limited clinical trial efficacy experience with the use of desloratadine in
adolescents12 through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than
4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than
4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet
removed without crushing it. The dose of orodispersible tablet is placed in the mouth where it will
disperse immediately. Water or other liquid is not needed to swallow the dose. The dose must be taken
as soon as the blister has been opened.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
14
Efficacy and safety of Neoclarityn 2.5 mg orodispersible tablets in children under 6 years of age have
not been established.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Neoclarityn orodispersible tablet.
Phenylalanine may be harmful for people with phenylketonuria.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in
breast-feeding women.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
In clinical trials, desloratadine in the syrup formulation was administered to a paediatric population.
The overall incidence of adverse events was similar between the desloratadine syrup and the placebo
groups and did not differ significantly than the safety profile seen in adult patients.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with Neoclarityn tablets were reported in
3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported
in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial
with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was
headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving
placebo. Other undesirable effects reported very rarely during the post-marketing period are listed in
the following table.
15
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Hepatobiliary disorders
Elevations of liver enzymes, increased bilirubin,
hepatitis
Musculoskeletal and connective tissue disorders
Myalgia
General disorders
Hypersensitivity reactions (such as anaphylaxis,
angioedema, dyspnoea, pruritus, rash, and urticaria)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine
times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H
1
-receptor
antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H
1
-
receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
in vitro
studies.
These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
In two single-dose trials, Neoclarityn oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data. In addition, Neoclarityn
orodispersible tablets were well tolerated in a multiple dose trial.
At the recommended dose, Neoclarityn 5 mg orodispersible tablet was found to be bioequivalent to the
Neoclarityn 5 mg conventional tablet and the Neoclarityn 5 mg oral lyophilisate formulations of
desloratadine. Therefore, the efficacy of Neoclarityn orodispersible tablet is expected to be the same as
with the Neoclarityn tablet formulation.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for
14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical
pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the
clinical dose) for ten days, no prolongation of QTc interval was seen.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose,
ketoconazole and erythromycin interaction trials.
16
Gastrointestinal disorders
Desloratadine does not readily penetrate the central nervous system. In clinical trials, at the
recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to
placebo. Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor
performance in clinical trials. In a single dose study performed in adults, desloratadine 5 mg did not
affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks
related to flying.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced
impairment in performance or increase in sleepiness. No significant differences were found in the
psychomotor test results between desloratadine and placebo groups, whether administered alone or
with alcohol.
In patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as
sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of
palate. Neoclarityn tablets effectively controlled symptoms for 24 hours. The efficacy of Neoclarityn
tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less
than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of
symptoms for 4 days or more per week and for more than 4 weeks.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total
score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the
domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,
in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was
effective in relieving pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other
antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-
responsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was
observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with
placebo. Treatment with Neoclarityn also significantly reduced interference with sleep and daytime
function, as measured by a four-point scale used to assess these variables.
5.2 Pharmacokinetic properties
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the
terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was
consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The
bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of
desloratadine. The prevalence of this poor metaboliser phenotype was comparable for adult (6 %) and
paediatric subjects 2- to 11-year old (6 %), and greater among Blacks (18 % adult, 16 % paediatric)
than Caucasians (2 % adult, 3 % paediatric) in both populations however the safety profile of these
subjects was not different from that of the general population.
17
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult
subjects, four subjects were found to be poor metabolisers of desloratadine. These subjects had a C
max
concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to
20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,
some interactions with other medicinal products can not be fully excluded. Desloratadine does not
inhibit CYP3A4
in vivo,
and
in vitro
studies have shown that the medicinal product does not inhibit
CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
In single-dose crossover studies of Neoclarityn 5 mg orodispersible tablets with Neoclarityn 5 mg
conventional tablets or Neoclarityn 5 mg oral lyophilisate, the formulations were bioequivalent.
Neoclarityn 2.5 mg tablets has not been evaluated in paediatric patients however in conjunction with
the dose finding studies in paediatrics, the pharmacokinetics data for Neoclarityn orodispersible tablets
supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
The presence of food has no relevant influence on AUC and C
max
of Neoclarityn oral lyophilisate
while the presence of food prolongs T
max
for desloratadine from 2.5 to 4 hours and T
max
for 3-OH-
desloratadine from 4 to 6 hours. In a separate study, grapefruit juice had no effect on the disposition of
desloratadine. Water had no affect on the bioavailability of Neoclarityn orodispersible tablets.
5.3 Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with
desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The
collective analysis of preclinical and clinical irritation studies for the orodispersible tablet indicate that
this formulation in unlikely to pose risk for local irritation with clinical use. The lack of carcinogenic
potential was demonstrated in studies conducted with desloratadine and loratadine.
6.
6.1 List of excipients
microcrystalline cellulose
pregelatinized starch
sodium starch glycolate
magnesium stearate
butylated methacrylate copolymer
crospovidone
sodium hydrogen carbonate
citric acid
colloidal silicon dioxide
ferric oxide
mannitol
aspartame (E951)
flavour Tutti-Frutti
6.2 Incompatibilities
18
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
Neoclarityn orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film
with foil lidding.
The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper
backed laminated aluminum foil lidding film.
The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an
oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to
polyvinyl chloride (PVC) film. Packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 orodispersible
tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7.
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium
8.
EU/1/00/161/035-046
9.
Date of first authorisation: 15 January 2001
Date of last renewal: 15 January 2006
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
19
1.
Neoclarityn 5 mg orodispersible tablets
2.
Each dose of Neoclarityn orodispersible tablet contains 5 mg desloratadine.
For a full list of excipients, see section 6.1.
3.
Orodispersible Tablet
Light-red, flat-faced, round, speckled tablets, one side branded with “A”
4.
Neoclarityn is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Adults and adolescents (12 years of age and over): one 5 mg Neoclarityn orodispersible tablet placed
in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including
intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
The dose can be taken regardless of mealtime.
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents
12 through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than
4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than
4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Immediately before use, the blister must be carefully peeled open and the dose of orodispersible tablet
removed without crushing it. The dose of orodispersible tablet is placed in the mouth where it will
disperse immediately. Water or other liquid is not needed to swallow the dose. The dose must be taken
as soon as the blister has been opened.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
20
Efficacy and safety of Neoclarityn orodispersible tablets in children under 12 years of age have not
been established.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Neoclarityn orodispersible tablet.
Phenylalanine may be harmful for people with phenylketonuria.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in
breast-feeding women.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with Neoclarityn tablets were reported in
3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported
in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial
with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was
headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving
placebo. Other undesirable effects reported very rarely during the post-marketing period are listed in
the following table.
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Elevations of liver enzymes, increased bilirubin,
hepatitis
Musculoskeletal and connective tissue disorders
Myalgia
General disorders
Hypersensitivity reactions (such as anaphylaxis,
angioedema, dyspnoea, pruritus, rash, and urticaria)
21
Hepatobiliary disorders
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine
times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H
1
-receptor
antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H
1
-
receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
in vitro
studies.
These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
In two single-dose trials, Neoclarityn oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data. In addition, Neoclarityn
orodispersible tablets were well tolerated in a multiple-dose trial.
At the recommended dose, Neoclarityn 5 mg orodispersible tablet was found to be bioequivalent to the
Neoclarityn 5 mg conventional tablet and the Neoclarityn 5 mg oral lyophilisate formulations of
desloratadine. Therefore, the efficacy of Neoclarityn orodispersible tablet is expected to be the same as
with the Neoclarityn tablet formulation.
In a multiple-dose clinical trial, in which up to 20 mg of desloratadine was administered daily for
14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical
pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the
clinical dose) for ten days, no prolongation of QTc interval was seen.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose,
ketoconazole and erythromycin interaction trials.
Desloratadine does not readily penetrate the central nervous system. In clinical trials, at the
recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to
placebo. Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor
performance in clinical trials. In a single dose study performed in adults, desloratadine 5 mg did not
affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks
related to flying.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced
impairment in performance or increase in sleepiness. No significant differences were found in the
psychomotor test results between desloratadine and placebo groups, whether administered alone or
with alcohol.
22
In patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as
sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of
palate. Neoclarityn tablets effectively controlled symptoms for 24 hours. The efficacy of Neoclarityn
tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less
than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of
symptoms for 4 days or more per week and for more than 4 weeks.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total
score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the
domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,
in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was
effective in relieving pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other
antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-
responsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was
observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with
placebo. Treatment with Neoclarityn also significantly reduced interference with sleep and daytime
function, as measured by a four-point scale used to assess these variables.
5.2 Pharmacokinetic properties
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the
terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was
consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The
bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of
desloratadine. The prevalence of this poor metaboliser phenotype was greater among Black adults than
Caucasian adults (18 % vs. 2 %) however the safety profile of these subjects was not different from
that of the general population.
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult
subjects, four subjects were found to be poor metabolisers of desloratadine. These subjects had a C
max
concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to
20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,
some interactions with other medicinal products can not be fully excluded. Desloratadine does not
inhibit CYP3A4
in vivo,
and
in vitro
studies have shown that the medicinal product does not inhibit
CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
23
In single-dose crossover studies of Neoclarityn 5 mg orodispersible tablets with Neoclarityn 5 mg
conventional tablets or Neoclarityn 5 mg oral lyophilisate, the formulations were bioequivalent.
The presence of food has no relevant influence on AUC and C
max
of Neoclarityn oral lyophilisate
while the presence of food prolongs T
max
for desloratadine from 2.5 to 4 hours and T
max
for 3-OH-
desloratadine from 4 to 6 hours. In a separate study, grapefruit juice had no effect on the disposition of
desloratadine. Water had no affect on the bioavailability of Neoclarityn orodispersible tablets.
5.3 Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with
desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The
collective analysis of preclinical and clinical irritation studies for the orodispersible tablet indicate that
this formulation is unlikely to pose risk for local irritation with clinical use. The lack of carcinogenic
potential was demonstrated in studies conducted with desloratadine and loratadine.
6.
6.1 List of excipients
microcrystalline cellulose
pregelatinized starch
sodium starch glycolate
magnesium stearate
butylated methacrylate copolymer
crospovidone
sodium hydrogen carbonate
citric acid
colloidal silicon dioxide
ferric oxide
mannitol
aspartame (E951)
flavour Tutti-Frutti
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
Neoclarityn orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film
with foil lidding.
24
The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper
backed laminated aluminum foil lidding film.
The cold form blister film is composed of polyvinyl chloride (PVC) film adhesively laminated to an
oriented polyamide (OPA) film, adhesively laminated to aluminum foil, adhesively laminated to
polyvinyl chloride (PVC) film. Packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 orodispersible
tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7.
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium
8.
EU/1/00/161/047-058
9.
Date of first authorisation: 15 January 2001
Date of last renewal: 15 January 2006
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
25
1.
Neoclarityn 0.5 mg/ml oral solution
2.
Each ml of oral solution contains 0.5 mg desloratadine.
This medicinal product contains 150 mg/ml of sorbitol
For a full list of excipients, see section 6.1.
Oral solution
4.
Neoclarityn is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Neoclarityn may be taken without regard to mealtime for the relief of symptoms associated with
allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin
(see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Neoclarityn.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Neoclarityn oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Neoclarityn oral solution once a day.
In adults and adolescents (12 years of age and over): 10 ml (5 mg) Neoclarityn oral solution once a
day.
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents
12 through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than
4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than
4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
26
Efficacy and safety of Neoclarityn oral solution in children under 1 year of age have not been
established.
In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish
from other forms of rhinitis. The absence of upper respiratory tract infection or structural
abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin
tests should be considered.
Approximately 6 % of adults and children 2- to 11-year old are phenotypic poor metabolisers of
desloratadine and exhibit a higher exposure (see section 5.2). The safety of desloratadine in children 2-
to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
The effects of desloratadine in poor metabolisers < 2 years of age have not been studied.
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
This medicinal product contains sorbitol; thus, patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in
breastfeeding women.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a
total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in
children 2 through 11 years of age was similar for the desloratadine and the placebo groups. In infants
and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were
diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %). In an additional study, no adverse events were
seen in subjects between 6 and 11 years of age following a single 2.5 mg dose of desloratadine oral
solution.
At the recommended dose, in clinical trials involving adults and adolescents in a range of indications
including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Neoclarityn were
reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse
27
events reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Other undesirable effects reported very rarely during the post-marketing period are listed in the
following table.
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Elevations of liver enzymes, increased bilirubin,
hepatitis
Musculoskeletal and connective tissue disorders
Myalgia
General disorders
Hypersensitivity reactions (such as anaphylaxis,
angioedema, dyspnoea, pruritus, rash, and urticaria)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine
was administered (nine times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H
1
-receptor
antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H
1
-
receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
in
vitro
studies. These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
Efficacy of Neoclarityn oral solution has not been investigated in separate paediatric trials. However,
the safety of Neoclarityn syrup, which contains the same concentration of desloratadine, was
demonstrated in three paediatric trials. Children, 1-11 years of age, who were candidates for
antihistamine therapy received a daily desloratadine dose of 1.25 mg (1 through 5 years of age) or
2.5 mg (6 through 11 years of age). Treatment was well tolerated as documented by clinical laboratory
tests, vital signs, and ECG interval data, including QTc. When given at the recommended doses, the
plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult
populations. Thus, since the course of allergic rhinitis/chronic idiopathic urticaria and the profile of
desloratadine are similar in adults and paediatric patients, desloratadine efficacy data in adults can be
extrapolated to the paediatric population.
In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was
administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was
28
Hepatobiliary disorders
observed. In a clinical pharmacology trial, in adults and adolescents, in which desloratadine was
administered to adults at a dose of 45 mg daily (nine times the clinical dose) for ten days, no
prolongation of QTc interval was seen.
Desloratadine does not readily penetrate the central nervous system. In controlled clinical trials, at the
recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of
somnolence as compared to placebo. Neoclarityn tablets given at a single daily dose of 7.5 mg to
adults and adolescents did not affect psychomotor performance in clinical trials. In a single dose study
performed in adults, desloratadine 5 mg did not affect standard measures of flight performance
including exacerbation of subjective sleepiness or tasks related to flying.
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol-
induced impairment in performance or increase in sleepiness. No significant differences were found in
the psychomotor test results between desloratadine and placebo groups, whether administered alone or
with alcohol.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose
ketoconazole and erythromycin interaction trials.
Efficacy of Neoclarityn syrup has not been investigated in paediatric trials in children less than
12 years of age.
In adult and adolescent patients with allergic rhinitis, Neoclarityn tablets were effective in relieving
symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness,
and itching of palate. Neoclarityn effectively controlled symptoms for 24 hours. The efficacy of
Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through
17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less
than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of
symptoms for 4 days or more per week and for more than 4 weeks.
Neoclarityn tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by
the total score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was
seen in the domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,
in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was
effective in relieving pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other
antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as non-
responsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was
observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with
placebo. Treatment with Neoclarityn also significantly reduced interference with sleep and daytime
function, as measured by a four-point scale used to assess these variables.
29
5.2 Pharmacokinetic properties
Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine
administration in adults and adolescents. Desloratadine is well absorbed with maximum concentration
achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The
degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and
a once daily dosing frequency. The bioavailability of desloratadine was dose proportional over the
range of 5 mg to 20 mg.
In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of
desloratadine. The prevalence of this poor metaboliser phenotype was comparable for adult (6 %) and
paediatric subjects 2- to 11-year old (6 %), and greater among Blacks (18 % adult, 16 % paediatric)
than Caucasians (2 % adult, 3 % paediatric) in both populations.
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult
subjects, four subjects were found to be poor metabolisers of desloratadine. These subjects had a C
max
concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours.
Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study
conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old
diagnosed with allergic rhinitis. The exposure (AUC) to desloratadine was about 6-fold higher and the
C
max
was about 3 to 4 fold higher at 3-6 hours with a terminal half-life of approximately 120 hours.
Exposure was the same in adult and paediatric poor metabolisers when treated with age-appropriate
doses. The overall safety profile of these subjects was not different from that of the general population.
The effects of desloratadine in poor metabolizers < 2 years of age have not been studied.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant active substance accumulation following once daily adult and adolescent dosing of
desloratadine (5 mg to 20 mg) for 14 days.
In a single dose, crossover study of desloratadine, the tablet and the syrup formulations were found to
be bioequivalent. As Neoclarityn oral solution contains the same concentration of desloratadine, no
bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC
and C
max
values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,
some interactions with other medicinal products can not be fully excluded. Desloratadine does not
inhibit CYP3A4
in vivo,
and
in vitro
studies have shown that the medicinal product does not inhibit
CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high
caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect
on the disposition of desloratadine.
5.3 Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with
desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.
Non-clinical data with desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The
lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and
loratadine.
30
6.
6.1 List of excipients
sorbitol,
propylene glycol,
sucralose E 955,
hypromellose 2910,
sodium citrate dihydrate,
natural and artificial flavour (bubblegum),
citric acid anhydrous,
disodium edetate,
purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not freeze. Store in the original package.
6.5 Nature and contents of container
Neoclarityn oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber
glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylene-
faced liner. All packages except the 150 ml package are supplied with a measuring spoon marked for
doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is
provided, marked for doses of 2.5 ml and 5 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium
8.
EU/1/00/161/059-067
9.
31
Date of first authorisation: 15 January 2001
Date of last renewal: 15 January 2006
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
32
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDERS
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
33
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release for film coated tablets
SP Labo N.V.
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Name and address of the manufacturer responsible for batch release for oral lyophilisate
SP Labo N.V.
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Name and address of the manufacturer responsible for batch release for orodispersible tablet
SP Labo N.V.
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Name and address of the manufacturer responsible for batch release for oral solution
SP Labo N.V.
Industriepark 30
2220 Heist-op-den-Berg
Belgium
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version
7.0
(December 2009)
presented in Module 1.8.1. of the Marketing Authorisation, is in place and
functioning before and whilst the product is on the market.
Risk Management Plan
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any
updated RMP should be submitted at the same time as the following Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted:
34
-
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
-
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
-
At the request of the EMEA
PSURs
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will
submit periodic safety update reports at two-yearly intervals unless otherwise decided by the CHMP.
35
ANNEX III
LABELLING AND PACKAGE LEAFLET
36
A. LABELLING
37
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS
1.
Neoclarityn 5 mg film-coated tablets
desloratadine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 5 mg desloratadine.
3.
LIST OF EXCIPIENTS
Includes : Lactose
See leaflet for further information.
4.
1 film-coated tablet
2 film-coated tablets
3 film-coated tablets
5 film-coated tablets
7 film-coated tablets
10 film-coated tablets
14 film-coated tablets
15 film-coated tablets
20 film-coated tablets
21 film-coated tablets
30 film-coated tablets
50 film-coated tablets
100 film-coated tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Swallow the tablet whole with water.
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
38
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not store above 30°C. Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
EU/1/00/161/001 1 tablet
EU/1/00/161/002 2 tablets
EU/1/00/161/003 3 tablets
EU/1/00/161/004 5 tablets
EU/1/00/161/005 7 tablets
EU/1/00/161/006 10 tablets
EU/1/00/161/007 14 tablets
EU/1/00/161/008 15 tablets
EU/1/00/161/009 20 tablets
EU/1/00/161/010 21 tablets
EU/1/00/161/011 30 tablets
EU/1/00/161/012 50 tablets
EU/1/00/161/013 100 tablets
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
39
16. INFORMATION IN BRAILLE
Neoclarityn
40
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS
1.
Neoclarityn 5 mg tablet
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
41
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 DOSES OF ORAL LYOPHILISATE
1.
Neoclarityn 5 mg oral lyophilisate
desloratadine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each dose of oral lyophilisate contains 5 mg desloratadine.
3.
LIST OF EXCIPIENTS
Contains mannitol and aspartame.
4.
1 dose of oral lyophylisate
2 doses of oral lyophylisate
3 doses of oral lyophylisate
5 doses of oral lyophylisate
7 doses of oral lyophylisate
10 doses of oral lyophylisate
14 doses of oral lyophylisate
15 doses of oral lyophylisate
20 doses of oral lyophylisate
21 doses of oral lyophylisate
30 doses of oral lyophylisate
50 doses of oral lyophylisate
100 doses of oral lyophylisate
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
42
EXP
9.
SPECIAL STORAGE CONDITIONS
Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
EU/1/00/161/022
1 dose of oral lyophylisate
EU/1/00/161/023
2 doses of oral lyophylisate
EU/1/00/161/024
3 doses of oral lyophylisate
EU/1/00/161/025
5 doses of oral lyophylisate
EU/1/00/161/026
7 doses of oral lyophylisate
EU/1/00/161/027
10 doses of oral lyophylisate
EU/1/00/161/028
14 doses of oral lyophylisate
EU/1/00/161/029
15 doses of oral lyophylisate
EU/1/00/161/030
20 doses of oral lyophylisate
EU/1/00/161/031
21 doses of oral lyophylisate
EU/1/00/161/032
30 doses of oral lyophylisate
EU/1/00/161/033
50 doses of oral lyophylisate
EU/1/00/161/034
100 doses of oral lyophylisate
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
43
16. INFORMATION IN BRAILLE
Neoclarityn
44
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 DOSES OF ORAL LYOPHILISATE
1.
Neoclarityn 5 mg oral lyophilisate
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
45
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS
1.
Neoclarityn 2.5 mg orodispersible tablets
desloratadine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each dose of orodispersible tablet contains 2.5 mg desloratadine.
3.
LIST OF EXCIPIENTS
Contains mannitol and aspartame.
4.
5 orodispersible tablets
6 orodispersible tablets
10 orodispersible tablets
12 orodispersible tablets
15 orodispersible tablets
18 orodispersible tablets
20 orodispersible tablets
30 orodispersible tablets
50 orodispersible tablets
60 orodispersible tablets
90 orodispersible tablets
100 orodispersible tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
46
EXP
9.
SPECIAL STORAGE CONDITIONS
Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
EU/1/00/161/035
5 orodispersible tablets
EU/1/00/161/036
6 orodispersible tablets
EU/1/00/161/037
10 orodispersible tablets
EU/1/00/161/038
12 orodispersible tablets
EU/1/00/161/039
15 orodispersible tablets
EU/1/00/161/040
18 orodispersible tablets
EU/1/00/161/041
20 orodispersible tablets
EU/1/00/161/042
30 orodispersible tablets
EU/1/00/161/043
50 orodispersible tablets
EU/1/00/161/044
60 orodispersible tablets
EU/1/00/161/045
90 orodispersible tablets
EU/1/00/161/046
100 orodispersible tablets
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Neoclarityn 2.5 mg orodispersible tablet
47
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1.
Neoclarityn 2.5 mg orodispersible tablets
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
48
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS
1.
Neoclarityn 5 mg orodispersible tablets
desloratadine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each dose of orodispersible tablet contains 5 mg desloratadine.
3.
LIST OF EXCIPIENTS
Contains mannitol and aspartame.
4.
5 orodispersible tablets
6 orodispersible tablets
10 orodispersible tablets
12 orodispersible tablets
15 orodispersible tablets
18 orodispersible tablets
20 orodispersible tablets
30 orodispersible tablets
50 orodispersible tablets
60 orodispersible tablets
90 orodispersible tablets
100 orodispersible tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
49
EXP
9.
SPECIAL STORAGE CONDITIONS
Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
EU/1/00/161/047
5 orodispersible tablets
EU/1/00/161/048
6 orodispersible tablets
EU/1/00/161/049
10 orodispersible tablets
EU/1/00/161/050
12 orodispersible tablets
EU/1/00/161/051
15 orodispersible tablets
EU/1/00/161/052
18 orodispersible tablets
EU/1/00/161/053
20 orodispersible tablets
EU/1/00/161/054
30 orodispersible tablets
EU/1/00/161/055
50 orodispersible tablets
EU/1/00/161/056
60 orodispersible tablets
EU/1/00/161/057
90 orodispersible tablets
EU/1/00/161/058
100 orodispersible tablets
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Neoclarityn 5 mg orodispersible tablet
50
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1.
Neoclarityn 5 mg orodispersible tablets
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
51
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
1.
Neoclarityn 0.5 mg/ml oral solution
desloratadine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each ml of oral solution contains 0.5 mg desloratadine.
3.
LIST OF EXCIPIENTS
Includes: Propylene glycol, sorbitol.
See leaflet for further information.
4.
oral solution
30 ml with 1 spoon
50 ml with 1 spoon
60 ml with 1 spoon
100 ml with 1 spoon
120 ml with 1 spoon
150 ml with 1 spoon
150 ml with 1 oral syringe
225 ml with 1 spoon
300 ml with 1 spoon
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
52
9.
SPECIAL STORAGE CONDITIONS
Do not freeze. Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
EU/1/00/161/059
30 ml with 1 spoon
EU/1/00/161/060
50 ml with 1 spoon
EU/1/00/161/061
60 ml with 1 spoon
EU/1/00/161/062
100 ml with 1 spoon
EU/1/00/161/063
120 ml with 1 spoon
EU/1/00/161/064
150 ml with 1 spoon
EU/1/00/161/067
150 ml with 1 oral syringe
EU/1/00/161/065
225 ml with 1 spoon
EU/1/00/161/066
300 ml with 1 spoon
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Neoclarityn
53
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
1.
Neoclarityn 0.5 mg/ml oral solution
desloratadine
2.
METHOD OF ADMINISTRATION
Oral use
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
30 ml
50 ml
60 ml
100 ml
120 ml
150 ml
225 ml
300 ml
6.
LIST OF EXCIPIENTS
Includes: Propylene glycol, sorbitol.
See leaflet for further information.
7.
Marketing Authorisation Holder:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles, Belgium
54
8.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
9.
SPECIAL STORAGE CONDITIONS
Do not freeze. Store in the original package.
55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET : INFORMATION FOR THE USER
Neoclarityn 5 mg film-coated tablets
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Neoclarityn is and what it is used for
2.
Before you take Neoclarityn
3.
How to take Neoclarityn
4.
Possible side effects
5.
How to store Neoclarityn
6.
Further information
1.
WHAT NEOCLARITYN IS AND WHAT IT IS USED FOR
Neoclarityn is an antiallergy medicine that does not make you drowsy. It helps control your allergic
reaction and its symptoms.
Neoclarityn relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages
caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include
sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn is also used to relieve the symptoms associated with urticaria (a skin condition caused by
an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and
sleep.
2.
BEFORE YOU TAKE NEOCLARITYN
Do not take Neoclarityn
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of
Neoclarityn or to loratadine.
Neoclarityn is indicated for adults and adolescents (12 years of age and older).
Take special care with Neoclarityn
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Taking other medicines
There are no known interactions of Neoclarityn with other medicines.
Taking Neoclarityn with food and drink
Neoclarityn may be taken with or without a meal.
Pregnancy and breast-feeding
57
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-
feeding.
If you are pregnant or nursing a baby, taking Neoclarityn is not recommended.
Driving and using machines
At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
Important information about some of the ingredients of Neoclarityn
Neoclarityn tablets contain lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.
3.
HOW TO TAKE NEOCLARITYN
Adults and adolescents (12 years of age and older): take one tablet once a day.
Swallow the tablet whole with water, with or without food.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are
suffering from and will determine for how long you should take Neoclarityn.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less
than 4 weeks), your physician will recommend you a treatment schedule that will depend on the
evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you
should follow the instructions of your physician.
If you take more Neoclarityn than you should
Take Neoclarityn only as it is prescribed for you. No serious problems are expected with accidental
overdose. However, if you take more Neoclarityn than you were told to, contact your doctor or
pharmacist.
If you forget to take Neoclarityn
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing
schedule. Do not take a double dose to make up for a forgotten dose.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Neoclarityn can cause side effects, although not everybody gets them. In adults,
side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache
were reported more often than with a dummy tablet. In adolescents, headache was the most commonly
reported side effect.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat,
stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to
sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver
inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
58
5.
HOW TO STORE NEOCLARITYN
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original package.
Do not use Neoclarityn after the expiry date which is stated on the carton and blister. The expiry date
refers to the last day of that month.
Tell your pharmacist if you notice any change in the appearance of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Neoclarityn contains
-
The active substance is desloratadine 5 mg
-
The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline
cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate,
hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing
hypromellose, macrogol 400), carnauba wax, white wax.
What Neoclarityn looks like and contents of the pack
Neoclarityn 5 mg film-coated tablets are packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14,
15, 20, 21, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32-(0)2 370 92 11
Luxembourg/Luxemburg
Rue de Stalle 73
B-1180 Bruxelles/Brüssel
Belgique/Belgien
Tél/Tel: + 32-(0)2 370 92 11
България
Ийст Парк Трейд Център
Бул. „Н.Й.Вапцаров” 53А, ет. 2
BG-София 1407
Тел.: +359 2 806 3030
Magyarország
Alkotás u. 53.
H-1123 Budapest
Tel.: +36 1 457-8500
Česká republika
Ke Štvanici 3
CZ-186 00 Praha 8
Tel: +420 221771250
Malta
168 Christopher Street
MT-VLT02 Valletta
Tel: + 356-21 23 21 75
59
Danmark
Lautrupbjerg 2
DK-2750 Ballerup
Tlf: + 45-44 39 50 00
Nederland
Waarderweg 39
NL-2031 BN Haarlem
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Info@essex-pharma.de
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
Eesti
Järvevana tee 9
EE-11314 Tallinn
Tel: + 372 654 96 86
Österreich
Am Euro Platz 2
A-1120 Wien
Tel: + 43-(0) 1 813 12 31
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Tηλ.: + 30-210 98 97 300
Polska
Ul. Taśmowa 7
PL-02-677 Warszawa
Tel.: + 48-(0)22 478 41 50
España
Josefa Valcárcel,38
E-28027 Madrid
Tel: +34-91 321 06 00
Portugal
Rua Agualva dos Açores 16
P-2735-557 Agualva-Cacém
Tel: +351-21 433 93 00
France
34 avenue Léonard de Vinci
F-92400 Courbevoie
Tél: + 33-(0)1 80 46 40 40
România
Şos. Bucureşti-Ploieşti, nr. 17-21,
Băneasa Center, et. 8, sector 1
RO-013682 Bucureşti
Tel. + 40 21 233 35 30
Ireland
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
Tel: +44-(0)1 707 363 636
Slovenija
Dunajska 22
SI-1000 Ljubljana
Tel: + 386 01 3001070
Ísland
Hörgatún 2
IS-210 Garðabær
Sími: + 354 535 70 00
Slovenská republika
Strakova 5
SK-811 01 Bratislava
Tel: + 421 (2) 5920 2712
Italia
Via fratelli Cervi snc,
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39-02 21018.1
Suomi/Finland
PL 46/PB 46
FIN-02151 Espoo/Esbo
Puh/Tel: + 358 (0)9 804 650
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 7125
S-192 07 Sollentuna
Tel: + 46-(0)8 6261400
60
Latvija
Bauskas 58a-401
Rīga, LV-1004
Tel: + 371-7 21 38 25
United Kingdom
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW - UK
Tel: + 44-(0)1 707 363 636
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicinal product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu/
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
Neoclarityn 5 mg oral lyophilisate
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Neoclarityn oral lyophilisate is and what it is used for
2.
Before you take Neoclarityn oral lyophilisate
3.
How to take Neoclarityn oral lyophilisate
4.
Possible side effects
5.
How to store Neoclarityn oral lyophilisate
6.
Further information
1.
WHAT NEOCLARITYN ORAL LYOPHILISATE IS AND WHAT IT IS USED FOR
Neoclarityn oral lyophilisate is an antiallergy medicine that does not make you drowsy. It helps
control your allergic reaction and its symptoms.
Neoclarityn oral lyophilisate relieves symptoms associated with allergic rhinitis (inflammation of the
nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms
include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn oral lyophilisate is also used to relieve the symptoms associated with urticaria (a skin
condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and
sleep.
2.
BEFORE YOU TAKE NEOCLARITYN ORAL LYOPHILISATE
Do not take Neoclarityn
oral lyophilisate
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of
Neoclarityn oral lyophilisate, or to loratadine.
Neoclarityn oral lyophilisate is indicated for adults and adolescents (12 years of age and older).
Take special care with Neoclarityn oral lyophilisate
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Taking other medicines
There are no known interactions of Neoclarityn with other medicines.
62
Taking Neoclarityn oral lyophilisate with food and drink
Neoclarityn oral lyophilisate does not need to be taken with water or liquid. Additionally, Neoclarityn
oral lyophilisate may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-
feeding.
If you are pregnant or nursing a baby, taking Neoclarityn is not recommended.
Driving and using machines
At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
Important information about some of the ingredients of Neoclarityn
oral lyophilisate
This product contains aspartame 1.75 mg/dose. Aspartame is a source of phenylalanine, which may be
harmful for people with phenylketonuria.
3.
HOW TO TAKE NEOCLARITYN ORAL LYOPHILISATE
Before using, carefully peel open the blister and remove the dose of oral lyophilisate without crushing
it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to
swallow the dose.
Adults and adolescents (12 years of age and older): take one dose of Neoclarityn oral lyophilisate once
a day. Take the dose immediately after removal from the blister.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are
suffering from and will determine for how long you should take Neoclarityn oral lyophilisate.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less
than 4 weeks), your physician will recommend you a treatment schedule that will depend on the
evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you
should follow the instructions of your physician.
If you take more Neoclarityn oral lyophilisate than you should
Take Neoclarityn oral lyophilisate only as prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Neoclarityn oral lyophilisate than you were told to,
contact your doctor or pharmacist.
If you forget to take Neoclarityn
oral lyophilisate
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing
schedule. Do not take a double dose to make up for a forgotten dose.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Neoclarityn can cause side effects, although not everybody gets them. In adults,
side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache
were reported more often than with a dummy tablet. In adolescents, headache was the most commonly
reported side effect.
63
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat,
stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to
sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver
inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE NEOCLARITYN ORAL LYOPHILISATE
Keep out of the reach and sight of children.
Store in the original package.
Do not use Neoclarityn oral lyophilisate after the expiry date which is stated on the carton and blister.
The expiry date refers to the last day of that month.
Tell your pharmacist if you notice any change in the appearance of Neoclarityn oral lyophilisate.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Neoclarityn oral lyophilisate contains
-
The active substance is desloratadine 5 mg
-
The other ingredients are gelatin, mannitol, aspartame (E951), polacrilin potassium, Dye
Opatint Red (containing red iron oxide (E172) and hypromellose (E464)), flavour Tutti-Frutti,
and citric acid anhydrous.
What Neoclarityn oral lyophilisate looks like and contents of the pack
Neoclarityn oral lyophilisate is packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21,
30, 50, and 100 doses of oral lyophilisate.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32-(0)2 370 92 11
Luxembourg/Luxemburg
Rue de Stalle 73
B-1180 Bruxelles/Brüssel
Belgique/Belgien
Tél/Tel: + 32-(0)2 370 92 11
64
България
Ийст Парк Трейд Център
Бул. „Н.Й.Вапцаров” 53А, ет. 2
BG-София 1407
Тел.: +359 2 806 3030
Magyarország
Alkotás u. 53.
H-1123 Budapest
Tel.: +36 1 457-8500
Česká republika
Ke Štvanici 3
CZ-186 00 Praha 8
Tel: +420 221771250
Malta
168 Christopher Street
MT-VLT02 Valletta
Tel: + 356-21 23 21 75
Danmark
Lautrupbjerg 2
DK-2750 Ballerup
Tlf: + 45-44 39 50 00
Nederland
Waarderweg 39
NL-2031 BN Haarlem
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Info@essex-pharma.de
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
Eesti
Järvevana tee 9
EE-11314 Tallinn
Tel: + 372 654 96 86
Österreich
Am Euro Platz 2
A-1120 Wien
Tel: + 43-(0) 1 813 12 31
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Tηλ.: + 30-210 98 97 300
Polska
Ul. Taśmowa 7
PL-02-677 Warszawa
Tel.: + 48-(0)22 478 41 50
España
Josefa Valcárcel, 38
E-28027 Madrid
Tel: + 34-91 321 06 00
Portugal
Rua Agualva dos Açores 16
P-2735-557 Agualva-Cacém
Tel: +351-21 433 93 00
France
34 avenue Léonard de Vinci
F-92400 Courbevoie
Tél: + 33-(0)1 80 46 40 40
România
Şos. Bucureşti-Ploieşti, nr. 17-21,
Băneasa Center, et. 8, sector 1
RO-013682 Bucureşti
Tel. + 40 21 233 35 30
Ireland
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
Tel: +44-(0)1 707 363 636
Slovenija
Dunajska 22
SI-1000 Ljubljana
Tel: + 386 01 3001070
Ísland
Hörgatún 2
IS-210 Garðabær
Sími: + 354 535 70 00
Slovenská republika
Strakova 5
SK-811 01 Bratislava
Tel: + 421 (2) 5920 2712
65
Italia
Via fratelli Cervi snc,
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39-02 21018.1
Suomi/Finland
PL 46/PB 46
FIN-02151 Espoo/Esbo
Puh/Tel: + 358 (0)9 804 650
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 7125
S-192 07 Sollentuna
Tel: + 46-(0)8 6261400
Latvija
Bauskas 58a-401
Rīga, LV-1004
Tel: + 371-7 21 38 25
United Kingdom
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW - UK
Tel: + 44-(0)1 707 363 636
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicinal product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu/
66
PACKAGE LEAFLET: INFORMATION FOR THE USER
Neoclarityn 2.5 mg orodispersible tablets
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Neoclarityn orodispersible tablet is and what it is used for
2.
Before you take Neoclarityn orodispersible tablet
3.
How to take Neoclarityn orodispersible tablet
4.
Possible side effects
5.
How to store orodispersible tablet
6.
Further information
1.
WHAT NEOCLARITYN ORODISPERSIBLE TABLET IS AND WHAT IT IS USED
FOR
Neoclarityn orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps
control your allergic reaction and its symptoms.
Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of
the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These
symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin
condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and
sleep.
2.
BEFORE YOU TAKE NEOCLARITYN ORODISPERSIBLE TABLET
Do not take Neoclarityn orodispersible tablet
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of
Neoclarityn orodispersible tablet, or to loratadine.
Neoclarityn 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Take special care with Neoclarityn orodispersible tablet
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Taking other medicines
There are no known interactions of Neoclarityn with other medicines.
Taking Neoclarityn orodispersible tablet with food and drink
67
Neoclarityn orodispersible tablet does not need to be taken with water or liquid. Additionally,
Neoclarityn orodispersible tablet may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-
feeding.
If you are pregnant or nursing a baby taking Neoclarityn is not recommended.
Driving and using machines
At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
Important information about some of the ingredients of Neoclarityn
orodispersible tablet
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for
people with phenylketonuria.
3.
HOW TO TAKE NEOCLARITYN ORODISPERSIBLE TABLET
Before using, carefully peel open the blister and remove the dose of orodispersible tablet without
crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed
to swallow the dose.
Children 6 to 11 years of age: take one 2.5 mg Neoclarityn orodispersible tablet once a day. Take the
dose immediately after removal from the blister.
Adults and adolescents (12 years of age and older): take two 2.5 mg Neoclarityn orodispersible tablets
once a day. Take the dose immediately after removal from the blister.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are
suffering from and will determine for how long you should take Neoclarityn orodispersible tablets.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less
than 4 weeks), your physician will recommend you a treatment schedule that will depend on the
evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you
should follow the instructions of your physician.
If you take more Neoclarityn orodispersible tablet
than you should
Take Neoclarityn orodispersible tablet only as prescribed for you. No serious problems are expected
with accidental overdose. However, if you take more Neoclarityn orodispersible tablet than you were
told to, contact your doctor or pharmacist.
If you forget to take Neoclarityn orodispersible tablet
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing
schedule. Do not take a double dose to make up for forgotten individual doses.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Neoclarityn can cause side effects although not everybody gets them. In adults,
side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache
68
were reported more often than with a dummy tablet. In adolescents, headache was the most commonly
reported side effect.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat,
stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to
sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver
inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE NEOCLARITYN ORODISPERSIBLE TABLET
Keep out of the reach and sight of children.
Store in the original package.
Do not use Neoclarityn orodispersible tablet after the expiry date which is stated on the carton and
blister. The expiry date refers to the last day of that month.
Tell your pharmacist if you notice any change in the appearance of Neoclarityn orodispersible tablet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Neoclarityn orodispersible tablet contains
-
The active substance is desloratadine 2.5 mg
-
The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch
glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium
hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame
(E951) and flavour Tutti-Frutti.
What Neoclarityn orodispersible tablet looks like and contents of the pack
Neoclarityn 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one
side. Neoclarityn orodispersible tablet is packed in unit dose blisters in packs of
5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
69
België/Belgique/Belgien
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32-(0)2 370 92 11
Luxembourg/Luxemburg
Rue de Stalle 73
B-1180 Bruxelles/Brüssel
Belgique/Belgien
Tél/Tel: + 32-(0)2 370 92 11
България
Ийст Парк Трейд Център
Бул. „Н.Й.Вапцаров” 53А, ет. 2
BG-София 1407
Тел.: +359 2 806 3030
Magyarország
Alkotás u. 53.
H-1123 Budapest
Tel.: +36 1 457-8500
Česká republika
Ke Štvanici 3
CZ-186 00 Praha 8
Tel: +420 221771250
Malta
168 Christopher Street
MT-VLT02 Valletta
Tel: + 356-21 23 21 75
Danmark
Lautrupbjerg 2
DK-2750 Ballerup
Tlf: + 45-44 39 50 00
Nederland
Waarderweg 39
NL-2031 BN Haarlem
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Info@essex-pharma.de
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
Eesti
Järvevana tee 9
EE-11314 Tallinn
Tel: + 372 654 96 86
Österreich
Am Euro Platz 2
A-1120 Wien
Tel: + 43-(0) 1 813 12 31
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Tηλ.: + 30-210 98 97 300
Polska
Ul. Taśmowa 7
PL-02-677 Warszawa
Tel.: + 48-(0)22 478 41 50
España
Josefa Valcárcel, 38
E-28027 Madrid
Tel: + 34-91 321 06 00
Portugal
Rua Agualva dos Açores 16
P-2735-557 Agualva-Cacém
Tel: +351-21 433 93 00
France
34 avenue Léonard de Vinci
F-92400 Courbevoie
Tél: + 33-(0)1 80 46 40 40
România
Şos. Bucureşti-Ploieşti, nr. 17-21,
Băneasa Center, et. 8, sector 1
RO-013682 Bucureşti
Tel. + 40 21 233 35 30
Ireland
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
Tel: +44-(0)1 707 363 636
Slovenija
Dunajska 22
SI-1000 Ljubljana
Tel: + 386 01 3001070
70
Ísland
Hörgatún 2
IS-210 Garðabær
Sími: + 354 535 70 00
Slovenská republika
Strakova 5
SK-811 01 Bratislava
Tel: + 421 (2) 5920 2712
Italia
Via fratelli Cervi snc,
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39-02 21018.1
Suomi/Finland
PL 46/PB 46
FIN-02151 Espoo/Esbo
Puh/Tel: + 358 (0)9 804 650
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 7125
S-192 07 Sollentuna
Tel: + 46-(0)8 6261400
Latvija
Bauskas 58a-401
Rīga, LV-1004
Tel: + 371-7 21 38 25
United Kingdom
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW - UK
Tel: + 44-(0)1 707 363 636
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicinal product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu/
71
PACKAGE LEAFLET: INFORMATION FOR THE USER
Neoclarityn 5 mg orodispersible tablets
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Neoclarityn orodispersible tablet is and what it is used for
2.
Before you take Neoclarityn orodispersible tablet
3.
How to take Neoclarityn orodispersible tablet
4.
Possible side effects
5.
How to store Neoclarityn orodispersible tablet
6.
Further information
1.
WHAT NEOCLARITYN ORODISPERSIBLE TABLET IS AND WHAT IT IS USED
FOR
Neoclarityn orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps
control your allergic reaction and its symptoms.
Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of
the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These
symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin
condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and
sleep.
2.
BEFORE YOU TAKE NEOCLARITYN ORODISPERSIBLE TABLET
Do not take Neoclarityn
orodispersible tablet
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of
Neoclarityn orodispersible tablet, or to loratadine.
Neoclarityn 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and
older).
Take special care with Neoclarityn orodispersible tablet
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Taking other medicines
There are no known interactions of Neoclarityn with other medicines.
Taking Neoclarityn orodispersible tablet with food and drink
72
Neoclarityn orodispersible tablet does not need to be taken with water or liquid. Additionally,
Neoclarityn orodispersible tablet may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-
feeding.
If you are pregnant or nursing a baby, taking Neoclarityn is not recommended.
Driving and using machines
At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
Important information about some of the ingredients of Neoclarityn
orodispersible tablet
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for
people with phenylketonuria.
3.
HOW TO TAKE NEOCLARITYN ORODISPERSIBLE TABLET
Before using, carefully peel open the blister and remove the dose of orodispersible tablet without
crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed
to swallow the dose.
Adults and adolescents (12 years of age and older): take one 5 mg Neoclarityn orodispersible tablet
once a day. Take the dose immediately after removal from the blister.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are
suffering from and will determine for how long you should take Neoclarityn orodispersible tablets.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less
than 4 weeks), your physician will recommend you a treatment schedule that will depend on the
evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you
should follow the instructions of your physician.
If you take more Neoclarityn orodispersible tablet
than you should
Take Neoclarityn orodispersible tablet only as prescribed for you. No serious problems are expected
with accidental overdose. However, if you take more Neoclarityn orodispersible tablet than you were
told to, contact your doctor or pharmacist.
If you forget to take Neoclarityn orodispersible tablet
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing
schedule. Do not take a double dose to make up for forgotten individual doses.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Neoclarityn can cause side effects although not everybody gets them. In adults,
side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache
were reported more often than with a dummy tablet. In adolescents, headache was the most commonly
reported side effect.
73
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat,
stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to
sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver
inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE NEOCLARITYN ORODISPERSIBLE TABLET
Keep out of the reach and sight of children.
Store in the original package.
Do not use Neoclarityn orodispersible tablet after the expiry date which is stated on the carton and
blister. The expiry date refers to the last day of that month.
Tell your pharmacist if you notice any change in the appearance of Neoclarityn orodispersible tablet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Neoclarityn orodispersible tablet contains
-
The active substance is desloratadine 5 mg
-
The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch
glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium
hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame
(E951) and flavour Tutti-Frutti.
What Neoclarityn orodispersible tablet looks like and contents of the pack
Neoclarityn 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side
.
Neoclarityn orodispersible tablet
is packed in unit dose blisters in packs of
5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32-(0)2 370 92 11
Luxembourg/Luxemburg
Rue de Stalle 73
B-1180 Bruxelles/Brüssel
Belgique/Belgien
Tél/Tel: + 32-(0)2 370 92 11
74
България
Ийст Парк Трейд Център
Бул. „Н.Й.Вапцаров” 53А, ет. 2
BG-София 1407
Тел.: +359 2 806 3030
Magyarország
Alkotás u. 53.
H-1123 Budapest
Tel.: +36 1 457-8500
Česká republika
Ke Štvanici 3
CZ-186 00 Praha 8
Tel: +420 221771250
Malta
168 Christopher Street
MT-VLT02 Valletta
Tel: + 356-21 23 21 75
Danmark
Lautrupbjerg 2
DK-2750 Ballerup
Tlf: + 45-44 39 50 00
Nederland
Waarderweg 39
NL-2031 BN Haarlem
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Info@essex-pharma.de
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
Eesti
Järvevana tee 9
EE-11314 Tallinn
Tel: + 372 654 96 86
Österreich
Am Euro Platz 2
A-1120 Wien
Tel: + 43-(0) 1 813 12 31
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Tηλ.: + 30-210 98 97 300
Polska
Ul. Taśmowa 7
PL-02-677 Warszawa
Tel.: + 48-(0)22 478 41 50
España
Josefa Valcárcel, 38
E-28027 Madrid
Tel: + 34-91 321 06 00
Portugal
Rua Agualva dos Açores 16
P-2735-557 Agualva-Cacém
Tel: +351-21 433 93 00
France
34 avenue Léonard de Vinci
F-92400 Courbevoie
Tél: + 33-(0)1 80 46 40 40
România
Şos. Bucureşti-Ploieşti, nr. 17-21,
Băneasa Center, et. 8, sector 1
RO-013682 Bucureşti
Tel. + 40 21 233 35 30
Ireland
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
Tel: +44-(0)1 707 363 636
Slovenija
Dunajska 22
SI-1000 Ljubljana
Tel: + 386 01 3001070
Ísland
Hörgatún 2
IS-210 Garðabær
Sími: + 354 535 70 00
Slovenská republika
Strakova 5
SK-811 01 Bratislava
Tel: + 421 (2) 5920 2712
75
Italia
Via fratelli Cervi snc,
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39-02 21018.1
Suomi/Finland
PL 46/PB 46
FIN-02151 Espoo/Esbo
Puh/Tel: + 358 (0)9 804 650
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 7125
S-192 07 Sollentuna
Tel: + 46-(0)8 6261400
Latvija
Bauskas 58a-401
Rīga, LV-1004
Tel: + 371-7 21 38 25
United Kingdom
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW - UK
Tel: + 44-(0)1 707 363 636
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicinal product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu/
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
Neoclarityn 0.5 mg/ml oral solution
desloratadine
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Neoclarityn is and what it is used for
2.
Before you take Neoclarityn
3.
How to take Neoclarityn
4.
Possible side effects
5.
How to store Neoclarityn
6.
Further information
1.
WHAT NEOCLARITYN IS AND WHAT IT IS USED FOR
Neoclarityn oral solution is an antiallergy medicine that does not make you drowsy. It helps control
your allergic reaction and its symptoms.
Neoclarityn oral solution relieves symptoms associated with allergic rhinitis (inflammation of the
nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).These symptoms
include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn oral solution is also used to relieve the symptoms associated with urticaria (a skin
condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and
sleep.
2.
BEFORE YOU TAKE NEOCLARITYN
Do not take Neoclarityn
-
if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients
of Neoclarityn.
Neoclarityn oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of
age and older), and adults, including the elderly.
Take special care with Neoclarityn
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Neoclarityn.
Taking other medicines
There are no known interactions of Neoclarityn with other medicines.
77
Taking Neoclarityn
with food and drink
Neoclarityn may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-
feeding.
If you are pregnant or nursing a baby, taking Neoclarityn oral solution is not recommended.
Driving and using machines
At the recommended dose, Neoclarityn is not expected to cause you to be drowsy or less alert.
However, very rarely some people experience drowsiness, which may affect their ability to drive or
use machines.
Important information about some of the ingredients of Neoclarityn
Neoclarityn oral solution contains sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.
HOW TO TAKE NEOCLARITYN
Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Children 6 through 11 years of age: take 5 ml (one 5 ml spoonful) of oral solution once a day.
Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) of oral solution
once a day.
In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use
it to take the appropriate amount of oral solution.
Swallow the dose of oral solution, then drink some water. You can take this medicine with or without
food.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are
suffering from and will determine for how long you should take Neoclarityn oral solution.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less
than 4 weeks), your physician will recommend you a treatment schedule that will depend on the
evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more
than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you
should follow the instructions of your physician.
If you take more Neoclarityn than you should
Take Neoclarityn oral solution only as it is prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Neoclarityn oral solution than you were told to,
contact your doctor or pharmacist.
If you forget to take Neoclarityn
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing
schedule. Do not take a double dose to make up for a forgotten dose.
78
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Neoclarityn oral solution can cause side effects, although not everybody gets them.
In most children and adults, side effects with Neoclarityn were about the same as with a dummy
solution or tablet. However, common side effects in children less than 2 years of age were diarrhoea,
fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than
with a dummy tablet.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat,
stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to
sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver
inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE NEOCLARITYN
Keep out of the reach and sight of children.
Do not freeze. Store in the original package.
Do not use Neoclarityn after the expiry date which is stated on the bottle. The expiry date refers to the
last day of that month.
Tell your pharmacist if you notice any change in the appearance of the oral solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Neoclarityn contains
-
The active substance is desloratadine 0.5 mg/ml
-
The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955,
hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric
acid anhydrous, disodium edetate and purified water.
What Neoclarityn looks like and contents of the pack
Neoclarityn oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a
childproof cap. For all packages except the 150 ml bottle, a measuring spoon is provided, marked for
doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is
provided, marked for doses of 2.5 ml and 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
79
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32-(0)2 370 92 11
Luxembourg/Luxemburg
Rue de Stalle 73
B-1180 Bruxelles/Brüssel
Belgique/Belgien
Tél/Tel: + 32-(0)2 370 92 11
България
Ийст Парк Трейд Център
Бул. „Н.Й.Вапцаров” 53А, ет. 2
BG-София 1407
Тел.: +359 2 806 3030
Magyarország
Alkotás u. 53.
H-1123 Budapest
Tel.: +36 1 457-8500
Česká republika
Ke Štvanici 3
CZ-186 00 Praha 8
Tel: +420 221771250
Malta
168 Christopher Street
MT-VLT02 Valletta
Tel: + 356-21 23 21 75
Danmark
Lautrupbjerg 2
DK-2750 Ballerup
Tlf: + 45-44 39 50 00
Nederland
Waarderweg 39
NL-2031 BN Haarlem
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Info@essex-pharma.de
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
Eesti
Järvevana tee 9
EE-11314 Tallinn
Tel: + 372 654 96 86
Österreich
Am Euro Platz 2
A-1120 Wien
Tel: + 43-(0) 1 813 12 31
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Tηλ.: + 30-210 98 97 300
Polska
Ul. Taśmowa 7
PL-02-677 Warszawa
Tel.: + 48-(0)22 478 41 50
España
Josefa Valcárcel, 38
E-28027 Madrid
Tel: + 34-91 321 06 00
Portugal
Rua Agualva dos Açores 16
P-2735-557 Agualva-Cacém
Tel: +351-21 433 93 00
France
34 avenue Léonard de Vinci
F-92400 Courbevoie
Tél: + 33-(0)1 80 46 40 40
România
Şos. Bucureşti-Ploieşti, nr. 17-21,
Băneasa Center, et. 8, sector 1
RO-013682 Bucureşti
Tel. + 40 21 233 35 30
Ireland
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
Slovenija
Dunajska 22
SI-1000 Ljubljana
Tel: + 386 01 3001070
80
Tel: +44-(0)1 707 363 636
Ísland
Hörgatún 2
IS-210 Garðabær
Sími: + 354 535 70 00
Slovenská republika
Strakova 5
SK-811 01 Bratislava
Tel: + 421 (2) 5920 2712
Italia
Via fratelli Cervi snc,
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39-02 21018.1
Suomi/Finland
PL 46/PB 46
FIN-02151 Espoo/Esbo
Puh/Tel: + 358 (0)9 804 650
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 7125
S-192 07 Sollentuna
Tel: + 46-(0)8 6261400
Latvija
Bauskas 58a -401
Rīga, LV-1004
Tel: + 371-7 21 38 25
United Kingdom
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW - UK
Tel: + 44-(0)1 707 363 636
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicinal product is available on the website of the European Medicines
Agency
http://www.ema.europa.eu/
81
Source: European Medicines Agency
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