ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Aerinaze 2.5mg/120 mg modified-release tablets
2.
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
For a full list of excipients, see section 6.1.
3.
Modified-release tablet.
Blue and white bilayer oval tablet with “D12” branded to blue layer.
4.
Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Adults and adolescents 12 years of age and over:
The recommended dose of Aerinaze is one tablet twice a day. The tablet may be taken with a full glass of
water but must be swallowed entirely (without crushing, breaking or chewing it). The tablet may be taken
with or without food.
Aerinaze should not be used in children below the age of 12 years due to a lack of data on safety and
efficacy (see section 5.1).
The duration of treatment should be kept as short as possible and should not be continued after the
symptoms have disappeared. It is advisable to limit treatment to about 10 days, as during chronic
administration the activity of pseudoephedrine may diminish. After improvement of the congestive
condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if
necessary.
Hypersensitivity to the active substance, to any of the excipients, to adrenergic agents or to loratadine.
As Aerinaze contains pseudoephedrine, it is also contraindicated in patients who are receiving monoamine
oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Aerinaze is also contraindicated in patients with:
•
narrow-angle glaucoma,
•
urinary retention,
•
cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension,
•
hyperthyroidism,
2
•
a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic
stroke. This is due to the alpha-mimetic activity of pseudoephedrine in combination with other
vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine,
dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either
by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline,
naphazoline…).
Do not exceed the recommended dosage and the duration of treatment (see section 4.2).
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic
medicinal products, such as pseudoephedrine. The safety and efficacy of the combination have not been
established in this population, and there are insufficient data to give adequate dose recommendations.
Therefore the combination product should be used with caution in patients above 60 years of age.
Renal or hepatic impairment: The safety and efficacy of Aerinaze has not been established in patients with
impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
The combination product is not recommended for use in patients with impaired renal or hepatic function.
Aerinaze should not be used in children below the age of 12 years (see section 4.2).
Patients should be informed that the treatment should be discontinued in case of hypertension,
tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache
or increased headache).
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying
hypotension may be produced by sympathomimetic amines. These effects may be more likely to occur in
children, elderly patients, or in cases of overdose (see section 4.9).
Caution should be exercised in the following patient groups:
•
Patients receiving digitalis
•
Patients with cardiac arrhythmias
•
Patients with hypertension
•
Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive
anamnesis of bronchospasm.
Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of
the vesical cervix.
Caution should also be exercised in patients being treated with other sympathomimetics. These include:
•
decongestants
•
anorexogenics or amphetamine-type psychostimulants
•
antihypertensive agents
•
tricyclic antidepressants and other antihistamines.
Caution should be exercised in patients suffering from migraine who are currently being treated with ergot
alkaloid vasoconstrictors.
Pseudoephedrine sulphate carries the risk of abuse. Increased doses may ultimately produce toxicity.
Continuous use can lead to tolerance resulting in an increased risk of overdosing. Depression may follow
rapid withdrawal.
3
Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment
with indirect sympathomimetic agents. Therefore, if surgery is scheduled, it is preferable to discontinue
treatment 24 hours before anaesthesia.
Athletes should be informed that treatment with pseudoephedrine could lead to positive doping tests.
The administration of Aerinaze should be discontinued at least 48 hours before skin tests since
antihistamines maybe prevent or reduce other wise positive reaction to dermal reactivity index.
No interaction studies have been performed. However, no clinically relevant interactions or changes in
desloratadine plasma concentrations were observed in clinical trials with desloratadine in which
erythromycin or ketoconazole were co-administered.
Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood
pressure. Concurrent administration with sympathomimetic medicines may result in critical hypertension
reactions.
The following combinations are not recommended:
•
bromocriptine
•
cabergoline
•
lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Dihydroergotamine, ergotamine, methylergometrine: risk of vasoconstriction and increase in blood
pressure.
Other vasoconstrictors used as nasal decongestant, by oral or nasal route (phenylpropanolamine,
phenylephrine, ephedrine, oxymetazoline, naphazoline…): risk of vasoconstriction.
Sympathomimetic medicines reduce the antihypertensive effect of α-methyldopa, mecamylamine,
reserpine, veratrum alkaloids, and guanethidine.
Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.
The interaction with Aerinaze and alcohol has not been studied. However, in a clinical pharmacology trial
desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of
alcohol. No significant differences were found in the psychomotor test results between desloratadine and
placebo groups, whether administered alone or with alcohol.
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.
Neither desloratadine nor the combination of loratadine and pseudoephedrine were teratogenic in animal
studies. The safe use of Aerinaze during pregnancy has not been established; however experience from a
large number of exposed pregnancies in humans does not reveal any increase in the frequency of
malformations as compared to the incidence in the general population.
4
Because animal reproduction studies are not always predictive of human response, and due to the
vasoconstrictive properties of pseudoephedrine, Aerinaze should not be used during pregnancy.
Desloratadine and pseudoephedrine are both excreted in breast milk. Decreased milk production in
nursing mothers has been reported with pseudoephedrine. Therefore Aerinaze should not be used in
breast-feeding women.
No studies on the effects on the ability to drive and use machines have been performed with Aerinaze. 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.
It is not expected that pseudoephedrine sulphate impairs psychomotor performance.
4.8
In clinical trials involving 414 adults the most frequent of adverse events reported were insomnia (8.9 %),
dry mouth (7.2 %) and headache (3.1 %). These and other undesirable effects reported during the clinical
trials are listed in the following table.
Table 1: Adverse reactions reported during clinical trials for Aerinaze
very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100);
rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000)
Cardiac disorders
Common:
Uncommon:
Tachycardia
Palpitation, premature atrial contractions
Nervous system disorders
Common:
Uncommon:
Mouth dry, dizziness, psychomotor hyperactivity
Hyperkinesia, flushing, hot flushes, confusion
Eye disorders
Uncommon:
Blurred vision, dry eyes
Respiratory, thoracic and mediastinal disorders
Common:
Uncommon:
Pharyngitis
Rhinitis, sinusitis, epistaxis, nasal irritation,
rhinorrhea, dry throat, hyposmia
Gastrointestinal disorders
Common:
Uncommon:
Anorexia, constipation
Dyspepsia, nausea, abdominal pain, gastroenteritis,
stool abnormal
Renal and urinary disorders
Uncommon:
Dysuria, micturition disorder, altered micturition
frequency
Skin and subcutaneous tissue disorders
Uncommon:
Pruritus
Metabolism and nutrition disorders
Uncommon:
Thirst, glycosuria, hyperglycemia
5
General disorders and administration site
conditions
Common:
Uncommon:
Headache, fatigue
Headache aggravated, rigors
Hepatobiliary disorders
Uncommon:
Increased hepatic enzymes
Psychiatric disorders
Common:
Uncommon:
Insomnia, somnolence, sleep disorder, nervousness
Agitation, anxiety, irritability
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Other adverse reactions reported very rarely for desloratadine during the post-marketing period are listed
in Table 2.
Table 2: Adverse reactions reported during the post-marketing period for desloratadine
Psychiatric disorders
Hallucinations
Nervous system disorders
Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders
Tachycardia, palpitations
Gastrointestinal disorders
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)
Symptoms:
Symptoms of overdose are mostly of a sympathomimetic nature. Symptoms may vary from
CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse)
to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome. Other
symptoms may include: headache, anxiety, micturition difficulty, muscle weakness and tenseness,
euphoria, excitement, respiratory failure, cardiac arrhythmias, tachycardia, palpitations, thirst,
perspiration, nausea, vomiting, precordial pain, dizziness, tinnitus, ataxia, blurred vision and hypertension
or hypotension. CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry
mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). Some patients
may present a toxic psychosis with delusions and hallucinations.
Treatment:
In the event of overdose, start symptomatic and supportive treatment immediately and
maintain it for as long as necessary. Adsorption of active substance remaining in the stomach may be
attempted by administration of active charcoal suspended in water. Perform gastric lavage with
physiologic saline solution, particularly in children. In adults, tap water can be used. Remove as much as
possible of the amount administered before the next instillation. Desloratadine is not removed by
haemodialysis and it is not known if it is eliminated by peritoneal dialysis. After
emergency treatment,
continue to monitor the patient medically.
Treatment of the pseudoephedrine overdose is symptomatic and supportive. Stimulants (analeptics) must
not be used. Hypertension can be controlled with an adrenoceptor-blocking agent and tachycardia with a
6
beta-blocking agent. Short acting barbituates, diazepam or paraldehyde may be administered to control
seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or
hypothermia blanket. Apnoea is treated with respiratory assistance
.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines – H
1
antagonist, ATC code: R06A X27.
Pharmacotherapeutic group: Nasal decongestants for systemic use group, ATC code: R01BA52.
The pharmacodynamics of Aerinaze tablets are directly related to that of its components.
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.
Desloratadine does not readily penetrate the central nervous system. 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 controlled clinical trials, at the recommended dose
of 5 mg daily, there was no excess incidence of somnolence as compared to placebo. Desloratadine given
at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Pseudoephedrine sulphate (d-isoephedrine sulphate) is a sympathomimetic agent with mostly α-mimetic
activity in comparison with the β-activity. Pseudoephedrine sulphate provides a nasal decongestant effect
after oral administration due to its vasoconstrictive action. It has an indirect sympathomimetic effect due
primarily to the release of adrenergic mediators from the post-ganglionic nerve endings.
Oral administration of pseudoephedrine at the recommended dose can cause other sympathomimetic
effects, such as increased blood pressure, tachycardia or manifestations of central nervous system
excitation.
The clinical efficacy and safety of Aerinaze tablets was evaluated in two, 2-week multicentre, randomized
parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic
rhinitis, 414 of whom received Aerinaze tablets. In both trials, the antihistaminic efficacy of Aerinaze
tablets as measured by total symptom score, excluding nasal congestion, was significantly greater than
pseudoephedrine alone over the 2-week treatment period. In addition, the decongestant efficacy of
Aerinaze tablets, as measured by nasal stuffiness/congestion, was significantly greater than desloratadine
alone over the 2-week treatment period.
There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients
defined by gender, age, or race.
5.2 Pharmacokinetic properties
Desloratadine and Pseudoephedrine:
7
In a single dose pharmacokinetic study with Aerinaze, plasma concentration of desloratadine can be
detected within 30 minutes of administration. The mean time to maximum plasma concentrations (T
max
)
for desloratadine occurred at approximately 4-5 hours post dose and mean peak plasma concentrations
(C
max
) and area under the concentration-time curve (AUC) of approximately 1.09 ng/ml and 31.6 ng•hr/ml,
respectively, were observed. For pseudoephedrine, the mean T
max
occurred at 6-7 hours post dose and
mean peak plasma concentrations (C
max
and AUC) of approximately 263 ng/ml and 4,588 ng•hr/ml,
respectively, were observed. Food had no effect on the bioavailability (C
max
and AUC) of desloratadine or
pseudoephedrine. The half-life for desloratadine is 27.4 hours. The apparent half-life of pseudoephedrine
is 7.9 hours.
Following oral administration of Aerinaze for 14 days in normal healthy volunteers, steady-state
conditions were reached on day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine. For
desloratadine, mean steady state peak plasma concentrations (C
max
and AUC (0-12 h)) of approximately
1.7 ng/ml and 16 ng•hr/ml were observed, respectively. For pseudoephedrine, mean steady state peak
plasma concentrations (C
max
and AUC (0-12 h)) of 459 ng/ml and 4,658 ng•hr/ml were observed.
Desloratadine:
In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of
desloratadine. The prevalence of this poor metabolizer phenotype was greater among Blacks adults than
Caucasians 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.
Pseudoephedrine sulphate:
Its elimination half-life in humans, at an approximate urinary pH of 6, ranges from 5 to 8 hours. The
active substance and its metabolite are excreted in urine; 55-75 % of the administered dose is
excreted
unchanged. The rate of excretion is accelerated and the duration of action decreased in acidic urine (pH5).
In case of alkalinization of the urine, a partial resorption takes place.
A component interaction study demonstrated that the exposure (C
max
and AUC) of pseudoephedrine
following administration of pseudoephedrine alone was bioequivalent to pseudoephedrine exposure
following administration of the Aerinaze tablet. Therefore absorption of pseudoephedrine was not affected
by the Aerinaze formulation.
Pseudoephedrine is presumed to cross the placenta and the haematoencephalic barrier.
The active substance is excreted in breast milk of lactating women.
5.3 Preclinical safety data
No pre-clinical studies have been performed with Aerinaze. However, 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.
8
The combination of loratadine/pseudoephedrine sulphate used in acute and multiple-dose studies,
exhibited a low order of toxicity. The combination was not more toxic than their individual components,
and observed effects were generally related to the pseudoephedrine component.
During reproductive toxicity studies, the combination of loratadine/pseudoephedrine was not teratogenic
when administered orally to rats at doses up to 150 mg/kg/day and rabbits at doses up to 120 mg/kg/day.
6.
6.1
List of excipients
Blue, immediate-release layer
:
maize starch
microcrystalline cellulose
edetate disodium
citric acid
stearic acid
colorant (Indigo Carmine E132 Aluminum lake).
White, sustained-release layer
:
hypromellose 2208
microcrystalline cellulose
povidone K30
silicon dioxide
magnesium stearate.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 30°C. Keep the blisters in the outer carton.
6.5 Nature and contents of container
Aerinaze is supplied in unit dose blisters comprised of laminate blister film and foil lidding.
The blister consists of clear polychlortrifluorethylene/polyvinyl chloride (PCTFE/PVC) film, sealed with a
vinyl heat seal coated aluminum foil. Paper and/or polyester may be added to the outer surface of the foil.
Pack sizes of 2, 4, 7, 10, 14 and 20 tablets.
Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
No special requirements.
9
7.
SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium
8.
EU//07/399/001
EU//07/399/002
EU//07/399/003
EU//07/399/004
EU//07/399/005
EU//07/399/006
9.
30 July 2007
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/
10
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDERS
RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OF THE MARKETING AUTHORISATION
11
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
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 the version 7.0
(December 2009)
presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning
before and whilst the product is on the market.
Risk Management Plan
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any
updated RMP should be submitted at the same time as the following Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted:
-
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
12
ANNEX III
LABELLING AND PACKAGE LEAFLET
13
A. LABELLING
14
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
Aerinaze 2.5 mg/120 mg modified-release tablets
desloratadine/pseudoephedrine (as sulphate)
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
3. LIST OF EXCIPIENTS
2 modified-release tablets
4 modified-release tablets
7 modified-release tablets
10 modified-release tablets
14 modified-release tablets
20 modified-release tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Swallow the tablet whole with water.
Do not crush, break or chew.
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
15
EXP
9. SPECIAL STORAGE CONDITIONS
Do not store above 30°C.
Keep the blisters in the outer carton.
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/1/07/399/001 2 modified-release tablets
EU/1/07/399/002 4 modified-release tablets
EU/1/07/399/003 7 modified-release tablets
EU/1/07/399/004 10 modified-release tablets
EU/1/07/399/005 14 modified-release tablets
EU/1/07/399/006 20 modified-release tablets
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Aerinaze
16
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
Aerinaze 2.5 mg/120 mg modified-release tablets
desloratadine/pseudoephedrine (as sulphate)
SP Europe
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aerinaze 2.5 mg/120 mg modified-release tablet
desloratadine/pseudoephedrine (as sulphate)
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 Aerinaze is and what it is used for
2.
Before you take Aerinaze
4.
Possible side effects
5.
How to store Aerinaze
6.
Further information
1.
WHAT AERINAZE IS AND WHAT IT IS USED FOR
Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an antihistamine
and pseudoephedrine which is a decongestant. Antihistamines help to reduce allergic symptoms by
preventing the effects of a substance called histamine, which is produced by the body. Decongestants help
to clear nasal congestion.
Aerinaze tablets
relieve symptoms
associated with seasonal allergic rhinitis (
hay fever
), such as,
sneezing, runny or itchy nose, and eyes,
when accompanied by nasal congestion
.
2.
BEFORE YOU TAKE AERINAZE
-
Do not take Aerinaze
if you:
-
are
allergic
(hypersensitive) to desloratadine, loratadine, pseudoephedrine or to any of the other
ingredients of Aerinaze
-
have
high blood pressure
,
heart or blood vessel disease
or a
history of stroke
-
have
glaucoma
,
difficulty in urinating
,
urinary tract blockage
, or an
overactive thyroid
-
are taking
monoamine oxidase (MAO) inhibitor
(a class of antidepressant agents) therapy or have
stopped taking these types of medicines within the last 14 days.
Take special care with Aerinaze
Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine contained in
this medicine. Before taking Aerinaze, tell your doctor or pharmacist if you:
-
are
60 years of age or older
. Older adults may be more sensitive to the effects of this medicine
-
have,
diabetes
-
have intestinal
ulcers
leading to the narrowing of the stomach, small intestine or esophagus
(stenosing peptic ulcer)
19
3.
How to take Aerinaze
-
have
eye problems
(such as increased pressure in the eye or glaucoma)
-
have
intestinal blockage
(pyloral or duodenal blockage)
-
have
bladder neck blockage
(vesical cervix blockage)
-
have a history of
difficulty breathing
due to tightening of the lung muscles
(
bronchospasm)
-
have
prostate enlargement
-
have
problems with your
liver, kidney
,
or bladder
.
In addition, if you experience or are diagnosed with any of the
following conditions
you should tell your
doctor as he may advise you to stop taking Aerinaze:
-
high blood pressure
-
a fast or pounding heart beat
-
abnormal heart rhythm
-
feeling sick and headache
or increase headache while using Aerinaze.
If you are scheduled to have
surgery
, your doctor may advise you to stop taking Aerinaze for a few days
beforehand.
One of the active ingredients in Aerinaze, pseudoephedrine sulphate, has the potential to be abused and
large doses of pseudoephedrine sulphate can be toxic.
Laboratory Tests
Stop taking Aerinaze at least 48 hours before you have any skin tests.
Athletes taking Aerinaze may have positive doping-tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is especially important if you are taking:
-
digitalis
, a medicine used to treat certain heart disorders
-
medicines for
blood pressure
(e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids
and guanethidine)
-
decongestants
(oral or nasal)
-
diet pills
(appetite suppressants)
-
amphetamines
-
medicines for
migraines
e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or
methylergometrine)
-
an antibiotic called
linezolide
-
medicines for
Parkinson’s disease
or for
infertility
e.g. bromocriptine, cabergoline, lisuride and
pergolide
-
antacids for
indigestion
or
stomach problems
-
a medicine for
diarrhoea
called kaolin.
Taking Aerinaze with food and drink
Aerinaze tablets may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
Taking Aerinaze is not recommended if you are pregnant.
Decreased milk production in nursing mothers has been reported with pseudoephedrine, a component of
Aerinaze. If you are breast-feeding taking Aerinaze is not recommended.
Driving and using machines
20
At the recommended dose, Aerinaze 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.
3.
HOW TO TAKE AERINAZE
Always take Aerinaze tablets exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults and adolescents 12 years of age and over
: Take one Aerinaze tablet
twice daily with a glass of
water, with or without food. Swallow the tablet whole; do not crush, break or chew the tablet before
swallowing.
Aerinaze should
not
be used in children under 12 years of age.
Do not take more Aerinaze tablets than recommended on the label. Do not take Aerinaze tablets more
often than recommended.
Do not take this medicine for more than 10 days continuously unless your doctor tells you to do so.
If you take more Aerinaze than you should
If you take more Aerinaze than you were told to, tell your doctor or pharmacist immediately.
If you forget to take Aerinaze
If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing
schedule. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Aerinaze can cause side effects, although not everybody gets them. The following
side effects have been seen in studies:
Common (at least 1 in 100 patients) side effects associated with Aerinaze include:
•
fast heartbeat
•
restlessness with increased
body movement
•
dry mouth
•
dizziness
•
sore throat
•
decreased appetite
•
constipation
•
sugar in urine
•
increased sugar in blood
•
thirst
•
tiredness
•
headache
•
trouble sleeping
•
nervousness
•
drowsiness
21
Uncommon (at least 1 in 1,000 patients) side effects include:
•
pounding or irregular heart
beat
•
increased body movement
•
flushing
•
hot flushes
•
confusion
•
blurry vision
•
dry eyes
•
nose bleeds
•
irritated nose
•
inflammation of the nose
•
runny nose
•
inflammation of the sinus
•
dry throat
•
stomach pain
•
stomach flu
•
nausea
•
abnormal stool
•
painful or difficult
urination
•
problems urinating
•
changes in frequency of
urination
•
itching
•
chills
•
decreased sense of smell
•
abnormal liver function tests
•
agitation
•
anxiety
•
irritability
During the marketing of desloratadine, the following side effects have been reported very rarely:
•
severe allergic reactions
(difficulty in breathing,
wheezing, itching, hives and
swelling)
•
rash
•
palpitations
•
rapid heartbeat
•
stomach pain
•
nausea (feeling sick)
•
vomiting
•
upset stomach
•
diarrhoea
•
hallucinations
•
dizziness
•
drowsiness
•
inability to sleep
•
muscle pain
•
seizures
•
restlessness with increased
body movement
•
liver inflammation
•
abnormal liver function tests
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 AERINAZE
Keep out of the reach and sight of children.
Do not use Aerinaze after the expiry date which is stated on the blister.
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blisters in the outer carton.
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 Aerinaze contains
-
The active substances are desloratadine and pseudoephedrine (as sulphate)
-
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
-
The other ingredients are:
-
Inactive ingredients in the blue, immediate-release layer:
maize starch, microcrystalline
cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132,
Aluminum lake).
-
Inactive ingredients in the white, sustained-release layer:
hypromellose 2208, microcrystalline
cellulose, povidone K30, silicon dioxide and magnesium stearate.
22
What Aerinaze looks like and contents of the pack
Aerinaze is a blue and white oval bi-layer tablet with “D12” branded on the blue layer.
Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate blister film
and foil lidding.
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 medicine, 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
Walmolen 1
NL-3994 DL Houten
Tel: + 31-(0)800 9999000
Deutschland
Thomas-Dehler-Straße 27
D-81737 München
Tel: + 49-(0)89 627 31-0
Norge
Pb. 398
N-1326 Lysaker
Tlf: + 47 67 16 64 50
23
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
Km. 36, Ctra. Nacional I
E-28750 San Agustín de Guadalix – Madrid
Tel: + 34-91 848 85 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 86/PB 86
FIN-02151 Espoo/Esbo
Puh/Tel: + 358-(0)20-7570 300
Κύπρος
Οδός Αγίου Νικολάου, 8
CY-1055 Λευκωσία
Τηλ: +357-22 757188
Sverige
Box 6185
S-102 33 Stockholm
Tel: + 46-(0)8 522 21 500
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
24
Lietuva
Kęstučio g. 65/40
LT-08124 Vilnius
Tel. + 370 52 101868
This leaflet was last approved on
Detailed information on this medicine is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/
25
Source: European Medicines Agency
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