ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Aerius 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.
Aerius 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 Aerius tablets in children under 12 years of age have not been established.
In the case of severe renal insufficiency, Aerius 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 Aerius 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 Aerius during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Aerius 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 Aerius 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. Aerius 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, Aerius was effective in relieving symptoms such as sneezing, nasal
discharge and itching, as well as ocular itching, tearing and redness, and itching of palate. Aerius
effectively controlled symptoms for 24 hours. The efficacy of Aerius 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.
Aerius 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, Aerius 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 Aerius 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
Aerius 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, 90, 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/1/00/160/001-013
EU/1/00/160/036
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.
Aerius 5 mg oral lyophilisate
2.
Each dose of Aerius oral lyophilisate contains 5 mg desloratadine.
For a full list of excipients, see section 6.1.
3.
Oral lyophilisate
4.
Aerius 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 Aerius 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). Aerius 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 Aerius tablets in children under 12 years of age have not been established.
In the case of severe renal insufficiency, Aerius 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 Aerius tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Aerius 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 Aerius during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Aerius 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 Aerius 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.
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.
9
Hepatobiliary disorders
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, Aerius oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data.
At the recommended dose, Aerius oral lyophilisate was found to be bioequivalent to the conventional
tablet formulation of desloratadine. Therefore, the efficacy of Aerius oral lyophilisate is expected to be
the same as with the Aerius 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. Aerius 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, Aerius 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. Aerius
tablets effectively controlled symptoms for 24 hours. The efficacy of Aerius 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.
10
Aerius 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, Aerius 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 Aerius 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 Aerius oral lyophilisate with Aerius tablets, the formulations were
bioequivalent.
The presence of food has no relevant influence on AUC and C
max
of Aerius 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
Aerius 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/1/00/160/022-034
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.
Aerius 2.5 mg orodispersible tablets
2.
Each dose of Aerius 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.
Aerius 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 Aerius 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 Aerius 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 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.
14
Efficacy and safety of Aerius 2.5 mg orodispersible tablets in children under 6 years of age have not
been established.
In the case of severe renal insufficiency, Aerius should be used with caution.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
Phenylalanine may be harmful for people with phenylketonuria.
No clinically relevant interactions were observed in clinical trials with Aerius tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Aerius 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 Aerius during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Aerius 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 Aerius 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, Aerius oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data. In addition, Aerius
orodispersible tablets were well tolerated in a multiple dose trial.
At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the
Aerius 5 mg conventional tablet and the Aerius 5 mg oral lyophilisate formulations of desloratadine.
Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius
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. Aerius 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, Aerius 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. Aerius
tablets effectively controlled symptoms for 24 hours. The efficacy of Aerius 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.
Aerius 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, Aerius 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 Aerius 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 Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional
tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent. Aerius 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 Aerius 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 Aerius 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 Aerius 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
Aerius 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/1/00/160/037-048
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.
Aerius 5 mg orodispersible tablets
2.
Each dose of Aerius 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.
Aerius 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 Aerius 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 Aerius orodispersible tablets in children under 12 years of age have not been
established.
In the case of severe renal insufficiency, Aerius should be used with caution.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Aerius orodispersible tablet.
Phenylalanine may be harmful for people with phenylketonuria.
No clinically relevant interactions were observed in clinical trials with Aerius tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Aerius 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 Aerius during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Aerius 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 Aerius 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, Aerius oral lyophilisate was well tolerated as documented by clinical
laboratory findings, physical examinations, vital signs, and ECG interval data. In addition, Aerius
orodispersible tablets were well tolerated in a multiple-dose trial.
At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the
Aerius 5 mg conventional tablet and the Aerius 5 mg oral lyophilisate formulations of desloratadine.
Therefore, the efficacy of Aerius orodispersible tablet is expected to be the same as with the Aerius
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. Aerius 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, Aerius 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. Aerius
tablets effectively controlled symptoms for 24 hours. The efficacy of Aerius 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.
Aerius 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, Aerius 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 Aerius 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 Aerius 5 mg orodispersible tablets with Aerius 5 mg conventional
tablets or Aerius 5 mg oral lyophilisate, the formulations were bioequivalent.
The presence of food has no relevant influence on AUC and C
max
of Aerius 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 Aerius 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
Aerius 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/1/00/160/049-060
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.
Aerius 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.
3.
Oral solution
4.
Aerius is indicated for the relief of symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
urticaria (see section 5.1)
Aerius 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 Aerius.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Aerius oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Aerius oral solution once a day.
In adults and adolescents (12 years of age and over): 10 ml (5 mg) Aerius 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 Aerius 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, Aerius 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 Aerius tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial, Aerius 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 Aerius during pregnancy is therefore not
recommended.
Desloratadine is excreted into breast milk, therefore the use of Aerius 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 Aerius 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 %).
27
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 Aerius oral solution has not been investigated in separate paediatric trials. However, the
safety of Aerius 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
observed. In a clinical pharmacology trial, in adults and adolescents, in which desloratadine was
28
Hepatobiliary disorders
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. Aerius 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 Aerius syrup has not been investigated in paediatric trials in children less than 12 years of
age.
In adult and adolescent patients with allergic rhinitis, Aerius 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. Aerius effectively controlled symptoms for 24 hours. The efficacy of Aerius
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.
Aerius 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, Aerius 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 Aerius 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 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
29
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 Aerius 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
Aerius 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
EU/1/00/160/061-069
31
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/
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).
34
In addition, an updated RMP should be submitted:
-
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, 90, 100 TABLETS
1.
Aerius 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
90 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/1/00/160/001 1 tablet
EU/1/00/160/002 2 tablets
EU/1/00/160/003 3 tablets
EU/1/00/160/004 5 tablets
EU/1/00/160/005 7 tablets
EU/1/00/160/006 10 tablets
EU/1/00/160/007 14 tablets
EU/1/00/160/008 15 tablets
EU/1/00/160/009 20 tablets
EU/1/00/160/010 21 tablets
EU/1/00/160/011 30 tablets
EU/1/00/160/012 50 tablets
EU/1/00/160/036 90 tablets
EU/1/00/160/013 100 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
Aerius
40
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 TABLETS
1.
Aerius 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.
Aerius 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
42
8.
EXPIRY DATE
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/1/00/160/022
1 dose of oral lyophylisate
EU/1/00/160/023
2 doses of oral lyophylisate
EU/1/00/160/024
3 doses of oral lyophylisate
EU/1/00/160/025
5 doses of oral lyophylisate
EU/1/00/160/026
7 doses of oral lyophylisate
EU/1/00/160/027
10 doses of oral lyophylisate
EU/1/00/160/028
14 doses of oral lyophylisate
EU/1/00/160/029
15 doses of oral lyophylisate
EU/1/00/160/030
20 doses of oral lyophylisate
EU/1/00/160/031
21 doses of oral lyophylisate
EU/1/00/160/032
30 doses of oral lyophylisate
EU/1/00/160/033
50 doses of oral lyophylisate
EU/1/00/160/034
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
Aerius
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.
Aerius 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.
Aerius 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
46
8.
EXPIRY DATE
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/1/00/160/037
5 orodispersible tablets
EU/1/00/160/038
6 orodispersible tablets
EU/1/00/160/039
10 orodispersible tablets
EU/1/00/160/040
12 orodispersible tablets
EU/1/00/160/041
15 orodispersible tablets
EU/1/00/160/042
18 orodispersible tablets
EU/1/00/160/043
20 orodispersible tablets
EU/1/00/160/044
30 orodispersible tablets
EU/1/00/160/045
50 orodispersible tablets
EU/1/00/160/046
60 orodispersible tablets
EU/1/00/160/047
90 orodispersible tablets
EU/1/00/160/048
100 orodispersible tablets
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
47
16. INFORMATION IN BRAILLE
Aerius 2.5 mg orodispersible tablet
48
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1.
Aerius 2.5 mg orodispersible tablets
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
49
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS
1.
Aerius 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
50
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/1/00/160/049
5 orodispersible tablets
EU/1/00/160/050
6 orodispersible tablets
EU/1/00/160/051
10 orodispersible tablets
EU/1/00/160/052
12 orodispersible tablets
EU/1/00/160/053
15 orodispersible tablets
EU/1/00/160/054
18 orodispersible tablets
EU/1/00/160/055
20 orodispersible tablets
EU/1/00/160/056
30 orodispersible tablets
EU/1/00/160/057
50 orodispersible tablets
EU/1/00/160/058
60 orodispersible tablets
EU/1/00/160/059
90 orodispersible tablets
EU/1/00/160/060
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
Aerius 5 mg orodispersible tablet
51
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1.
Aerius 5 mg orodispersible tablets
desloratadine
2.
SP Europe
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
52
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.
Aerius 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
53
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/1/00/160/061
30 ml with 1 spoon
EU/1/00/160/062
50 ml with 1 spoon
EU/1/00/160/063
60 ml with 1 spoon
EU/1/00/160/064
100 ml with 1 spoon
EU/1/00/160/065
120 ml with 1 spoon
EU/1/00/160/066
150 ml with 1 spoon
EU/1/00/160/069
150 ml with 1 oral syringe
EU/1/00/160/067
225 ml with 1 spoon
EU/1/00/160/068
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
Aerius
54
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.
Aerius 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
55
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.
56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET : INFORMATION FOR THE USER
Aerius 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 Aerius is and what it is used for
2.
Before you take Aerius
3.
How to take Aerius
4.
Possible side effects
5.
How to store Aerius
6.
Further information
1.
WHAT AERIUS IS AND WHAT IT IS USED FOR
Aerius is an antiallergy medicine that does not make you drowsy. It helps control your allergic
reaction and its symptoms.
Aerius 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.
Aerius 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 AERIUS
Do not take Aerius
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Aerius or
to loratadine.
Aerius is indicated for adults and adolescents (12 years of age and older).
Take special care with Aerius
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Aerius.
Taking other medicines
There are no known interactions of Aerius with other medicines.
Taking Aerius with food and drink
Aerius may be taken with or without a meal.
Pregnancy and breast-feeding
58
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 Aerius is not recommended.
Driving and using machines
At the recommended dose, Aerius 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 Aerius
Aerius 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 AERIUS
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 Aerius.
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 Aerius than you should
Take Aerius only as it is prescribed for you. No serious problems are expected with accidental
overdose. However, if you take more Aerius than you were told to, contact your doctor or pharmacist.
If you forget to take Aerius
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, Aerius 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 Aerius, 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.
59
5.
HOW TO STORE AERIUS
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original package.
Do not use Aerius 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 Aerius 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 Aerius looks like and contents of the pack
Aerius 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, 90 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
60
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
61
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/
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aerius 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 Aerius oral lyophilisate is and what it is used for
2.
Before you take Aerius oral lyophilisate
3.
How to take Aerius oral lyophilisate
4.
Possible side effects
5.
How to store Aerius oral lyophilisate
6.
Further information
1.
WHAT AERIUS ORAL LYOPHILISATE IS AND WHAT IT IS USED FOR
Aerius oral lyophilisate is an antiallergy medicine that does not make you drowsy. It helps control
your allergic reaction and its symptoms.
Aerius 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.
Aerius 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 AERIUS ORAL LYOPHILISATE
Do not take Aerius
oral lyophilisate
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Aerius
oral lyophilisate, or to loratadine.
Aerius oral lyophilisate is indicated for adults and adolescents (12 years of age and older).
Take special care with Aerius 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 Aerius.
Taking other medicines
There are no known interactions of Aerius with other medicines.
63
Taking Aerius oral lyophilisate with food and drink
Aerius oral lyophilisate does not need to be taken with water or liquid. Additionally, Aerius 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 Aerius is not recommended.
Driving and using machines
At the recommended dose, Aerius 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 Aerius
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 AERIUS 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 Aerius 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 Aerius 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 Aerius oral lyophilisate than you should
Take Aerius oral lyophilisate only as prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Aerius oral lyophilisate than you were told to, contact
your doctor or pharmacist.
If you forget to take Aerius
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, Aerius 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.
64
During the marketing of Aerius, 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 AERIUS ORAL LYOPHILISATE
Keep out of the reach and sight of children.
Store in the original package.
Do not use Aerius 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 Aerius 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 Aerius 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 Aerius oral lyophilisate looks like and contents of the pack
Aerius 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
65
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
66
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/
67
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aerius 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 Aerius orodispersible tablet is and what it is used for
2.
Before you take Aerius orodispersible tablet
3.
How to take Aerius orodispersible tablet
4.
Possible side effects
5.
How to store orodispersible tablet
6.
Further information
1.
WHAT AERIUS ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
Aerius orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps control
your allergic reaction and its symptoms.
Aerius 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.
Aerius 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 AERIUS ORODISPERSIBLE TABLET
Do not take Aerius orodispersible tablet
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Aerius
orodispersible tablet, or to loratadine.
Aerius 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Take special care with Aerius 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 Aerius.
Taking other medicines
There are no known interactions of Aerius with other medicines.
68
Taking Aerius orodispersible tablet with food and drink
Aerius orodispersible tablet does not need to be taken with water or liquid. Additionally, Aerius
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 Aerius is not recommended.
Driving and using machines
At the recommended dose, Aerius 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 Aerius
orodispersible tablet
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for
people with phenylketonuria.
3.
HOW TO TAKE AERIUS 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 Aerius 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 Aerius 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 Aerius 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 Aerius orodispersible tablet
than you should
Take Aerius orodispersible tablet only as prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Aerius orodispersible tablet than you were told to,
contact your doctor or pharmacist.
If you forget to take Aerius 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, Aerius 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
69
reported more often than with a dummy tablet. In adolescents, headache was the most commonly
reported side effect.
During the marketing of Aerius, 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 AERIUS ORODISPERSIBLE TABLET
Keep out of the reach and sight of children.
Store in the original package.
Do not use Aerius 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 Aerius 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 Aerius 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 Aerius orodispersible tablet looks like and contents of the pack
Aerius 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.
Aerius 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:
70
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
71
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/
72
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aerius 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 Aerius orodispersible tablet is and what it is used for
2.
Before you take Aerius orodispersible tablet
3.
How to take Aerius orodispersible tablet
4.
Possible side effects
5.
How to store Aerius orodispersible tablet
6.
Further information
1.
WHAT AERIUS ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
Aerius orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps control
your allergic reaction and its symptoms.
Aerius 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.
Aerius 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 AERIUS ORODISPERSIBLE TABLET
Do not take Aerius
orodispersible tablet
-
if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Aerius
orodispersible tablet, or to loratadine.
Aerius 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Take special care with Aerius 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 Aerius.
Taking other medicines
There are no known interactions of Aerius with other medicines.
73
Taking Aerius orodispersible tablet with food and drink
Aerius orodispersible tablet does not need to be taken with water or liquid. Additionally, Aerius
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 Aerius is not recommended.
Driving and using machines
At the recommended dose, Aerius 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 Aerius
orodispersible tablet
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for
people with phenylketonuria.
3.
HOW TO TAKE AERIUS 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 Aerius 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 Aerius 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 Aerius orodispersible tablet
than you should
Take Aerius orodispersible tablet only as prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Aerius orodispersible tablet than you were told to,
contact your doctor or pharmacist.
If you forget to take Aerius 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, Aerius 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.
74
During the marketing of Aerius, 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 AERIUS ORODISPERSIBLE TABLET
Keep out of the reach and sight of children.
Store in the original package.
Do not use Aerius 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 Aerius 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 Aerius 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 Aerius orodispersible tablet looks like and contents of the pack
Aerius 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side
.
Aerius 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
75
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
76
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/
77
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aerius 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 Aerius is and what it is used for
2.
Before you take Aerius
3.
How to take Aerius
4.
Possible side effects
5.
How to store Aerius
6.
Further information
1.
WHAT AERIUS IS AND WHAT IT IS USED FOR
Aerius oral solution is an antiallergy medicine that does not make you drowsy. It helps control your
allergic reaction and its symptoms.
Aerius 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.
Aerius 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 AERIUS
Do not take Aerius
-
if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients
of Aerius.
Aerius 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 Aerius
-
if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Aerius.
Taking other medicines
There are no known interactions of Aerius with other medicines.
78
Taking Aerius
with food and drink
Aerius 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 Aerius oral solution is not recommended.
Driving and using machines
At the recommended dose, Aerius 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 Aerius
Aerius 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 AERIUS
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 Aerius 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 Aerius than you should
Take Aerius oral solution only as it is prescribed for you. No serious problems are expected with
accidental overdose. However, if you take more Aerius oral solution than you were told to, contact
your doctor or pharmacist.
If you forget to take Aerius
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.
79
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Aerius oral solution can cause side effects, although not everybody gets them. In
most children and adults, side effects with Aerius 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 Aerius, 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 AERIUS
Keep out of the reach and sight of children.
Do not freeze. Store in the original package.
Do not use Aerius 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 Aerius 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 Aerius looks like and contents of the pack
Aerius 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.
80
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
81
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/
82
Source: European Medicines Agency
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