Aerinaze

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



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1. NAME OF THE MEDICINAL PRODUCT

Aerinaze 2.5 mg/120 mg modified-release tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate. 
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Modified-release tablet.
Blue and white bilayer oval tablet with “D12” branded to blue layer.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of 
seasonal allergic rhinitis when accompanied by nasal congestion. 

4.2 Posology and method of administration

Posology
The recommended dose of Aerinaze is one tablet twice a day. 

The recommended dosage and the duration of treatment should not be exceeded.

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 sulphate may diminish. After improvement of the 
congestive condition of the mucosae of the upper airway, treatment may be maintained with 
desloratadine alone, if necessary.

Elderly patients
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic 
medicinal products, such as pseudoephedrine sulphate. The safety and efficacy of Aerinaze have not 
been established in this population, and there are insufficient data to give adequate dose 
recommendations. Therefore Aerinaze should be used with caution in patients above 60 years of age.

Patients with renal or hepatic impairment
The safety and efficacy of Aerinaze have not been established in patients with impaired renal or 
hepatic function, and there are insufficient data to give adequate dose recommendations. Aerinaze is 
not recommended for use in patients with impaired renal or hepatic function.

Paediatric population
The safety and efficacy of Aerinaze in children below the age of 12 years have not been established.
No data are available. Aerinaze is not recommended for use in children below the age of 12 years.

Method of administration

Oral use.

 



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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.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to adrenergic 
medicinal products or to loratadine. 

As Aerinaze contains pseudoephedrine sulphate, 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,
 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 sulphate 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…). 

4.4 Special warnings and precautions for use

Cardiovascular and general effects
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).

Caution should be exercised in the following patient groups:
 Patients with cardiac arrhythmias
 Patients with hypertension
 Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or 

positive anamnesis of bronchospasm
 Patients receiving digitalis (see section 4.5)

Gastrointestinal and genitourinary effects
Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction 
of the vesical cervix.

Central nervous system effects
Caution should also be exercised in patients being treated with other sympathomimetics (see 
section 4.5). These include:
 decongestants
 anorexogenics or amphetamine-type psychostimulants
 antihypertensive medicinal products
 tricyclic antidepressants and other antihistamines.

Caution should be exercised in patients suffering from migraine who are currently being treated with 
ergot alkaloid vasoconstrictors (see section 4.5).

 



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Convulsions
Desloratadine should be administered with caution in patients with medical or familial history of 
seizures, and mainly young children, being more susceptible to develop new seizures under 
desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients 
who experience a seizure while on treatment.

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 adolescents from 12 years old, elderly patients, or in cases of overdose (see section 4.9).

Risks of abuse
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.

Other
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.

Interference with serological testing
Athletes should be informed that treatment with pseudoephedrine sulphate 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 otherwise positive reaction to dermal reactivity index.

Severe skin reactions
Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with 
pseudoephedrine-containing products. Patients should be carefully monitored. If signs and symptoms 
such as pyrexia, erythema or many small pustules are observed, administration of Aerinaze should be 
discontinued and appropriate measures taken if needed.

4.5 Interaction with other medicinal products and other forms of interaction

Aerinaze
The following combinations are not recommended:
 digitalis (see section 4.4)
 bromocriptine
 cabergoline
 lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.

No interaction studies have been performed with the combination of desloratadine and 
pseudoephedrine sulphate.

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. Alcohol use should be 
avoided during Aerinaze treatment.

Desloratadine
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. 

 



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The enzyme responsible for the metabolism of desloratadine has not been identified yet, and 
therefore, some interactions with other medicinal products cannot 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.

Pseudoephedrine sulphate
Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.

Sympathomimetics
Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood 
pressure. 

Concurrent administration with other sympathomimetics (decongestants, anorexogenics or 
amphetamine-type psychostimulants, antihypertensive medicinal products, tricyclic antidepressants 
and other antihistamines) may result in critical hypertension reactions (see section 4.4).

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.

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the 
combination of desloratadine and pseudoephedrine sulphate in pregnant women. Animal studies do 
not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
As a precautionary measure, it is preferable to avoid the use of Aerinaze during pregnancy.

Breast-feeding
Desloratadine and pseudoephedrine sulphate have been identified in breastfed newborns/infants of 
treated women. There is insufficient information on the effects of desloratadine and pseudoephedrine 
sulphate in newborns/infants. Decreased milk production in nursing mothers has been reported with 
pseudoephedrine sulphate. Aerinaze should not be used during breast-feeding.

Fertility
There are no data available on male and female fertility.

4.7 Effects on ability to drive and use machines

Aerinaze has no or negligible influence on the ability to drive and use machines. Patients should be 
informed that most people do not experience drowsiness. Nevertheless, as there is individual variation in 
response to all medicinal products, it is recommended that patients are advised not to engage in activities 
requiring mental alertness, such as driving a car or using machines, until they have established their own 
response to the medicinal product.

4.8 Undesirable effects

Summary of the safety profile
In clinical trials involving 414 adults the most frequent of adverse reactions reported were insomnia 
(8.9 %), dry mouth (7.2 %) and headache (3.1 %). 

 



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Tabulated list of adverse reactions
Adverse reactions considered by investigators to be causally related to Aerinaze are listed below by 
System Organ Class. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), 
uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not 
known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse reactions seen with Aerinaze

Metabolism and nutrition 
disorders

Common

Uncommon

Decreased appetite

Thirst, glycosuria, hyperglycaemia 

Psychiatric disorders Common

Uncommon

Insomnia, somnolence, sleep disorder, 
nervousness
Agitation, anxiety, irritability

Nervous system disorders Common

Uncommon

Dizziness, psychomotor hyperactivity 

Hyperkinesia, confusional state

Eye disorders Uncommon Vision blurred, dry eye

Cardiac disorders Common

Uncommon

Tachycardia

Palpitation, supraventricular extrasystoles

Respiratory, thoracic and 
mediastinal disorders

Common 

Uncommon

Pharyngitis

Rhinitis, sinusitis, epistaxis, nasal discomfort, 
rhinorrhea, dry throat, hyposmia

Gastrointestinal disorders Common

Uncommon

Constipation

Dyspepsia, nausea, abdominal pain, 
gastroenteritis, abnormal faeces

Skin and subcutaneous tissue 
disorders

Uncommon Pruritus

Renal and urinary disorders Uncommon Dysuria, micturition disorder

General disorders and 
administration site 
conditions 

Common

Uncommon

Headache, fatigue, dry mouth

Chills, flushing, hot flush

Investigations Uncommon Hepatic enzymes increased

 



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Other adverse reactions reported for desloratadine during the post-marketing period are listed 
hereunder.

System Organ Class Frequency Adverse reactions

Immune system disorders Very rare Hypersensitivity (such as anaphylaxis, 
angioedema, dyspnoea, pruritus, rash, and 
urticaria)

Metabolism and nutrition 
disorders

Not known Increased appetite

Psychiatric disorders Very rare

Not known

Hallucination

Abnormal behaviour, aggression
Nervous system disorders Very rare Convulsion

Cardiac disorders Not known QT prolongation

Gastrointestinal disorders Very rare Vomiting, diarrhoea

Hepatobiliary disorders Very rare Hepatitis

Musculoskeletal and 
connective tissue disorders

Very rare Myalgia

Investigations Very rare

Not known

Blood bilirubin increased 

Weight increased

Cases of severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been 
reported with pseudoephedrine-containing products.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.

4.9 Overdose

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.

Management
In the event of overdose, symptomatic and supportive treatment immediately should be started and 
maintained it for as long as necessary. Adsorption of active substance remaining in the stomach may 

 

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be attempted by administration of active charcoal suspended in water. Gastric lavage with physiologic 
saline solution may be performed, particularly in children. In adults, tap water can be used. As much 
as possible of the amount administered should be removed 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, medical monitoring of the patient should be continued.

Treatment of the pseudoephedrine sulphate overdose is symptomatic and supportive. Stimulants 
(analeptics) must not be used. Hypertension can be controlled with an adrenoceptor-blocking agent 
and tachycardia with a beta-blocking agent. Short acting barbiturates, 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. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Nasal preparations, nasal decongestants for systemic use, ATC code: 
R01BA52.

Mechanism of action
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-
receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral 
histamine H1-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 -
mimetic activity in comparison with the -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 sulphate at the recommended dose can cause other 
sympathomimetic effects, such as increased blood pressure, tachycardia or manifestations of central 
nervous system excitation.

Pharmacodynamic effects
The pharmacodynamic effects of Aerinaze tablets are directly related to that of its components.

Clinical efficacy and safety
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 sulphate alone over the 2-week treatment period. In addition, the 

 



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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 sulphate:

Absorption
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 
(Tmax) for desloratadine occurred at approximately 4-5 hours post dose and mean peak plasma 
concentrations (Cmax) 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 sulphate, the mean 
Tmax occurred at 6-7 hours post dose and mean peak plasma concentrations (Cmax and AUC) of 
approximately 263 ng/ml and 4,588 ng•hr/ml, respectively, were observed. Food had no effect on the 
bioavailability (Cmax and AUC) of desloratadine or pseudoephedrine sulphate. The half-life for 
desloratadine is 27.4 hours. The apparent half-life of pseudoephedrine sulphate 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
sulphate. For desloratadine, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of 
approximately 1.7 ng/ml and 16 ng•hr/ml were observed, respectively. For pseudoephedrine sulphate, 
mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of 459 ng/ml and 
4,658 ng•hr/ml were observed.

- Desloratadine 

Absorption
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 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 Cmax concentration about 3-fold higher at approximately 7 hours 
with a terminal phase half-life of approximately 89 hours.

Distribution
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.

- Pseudoephedrine sulphate

Absorption
A component interaction study demonstrated that the exposure (Cmax and AUC) of pseudoephedrine
sulphate following administration of pseudoephedrine sulphate alone was bioequivalent to 
pseudoephedrine sulphate exposure following administration of the Aerinaze tablet. Therefore 
absorption of pseudoephedrine sulphate was not affected by the Aerinaze formulation.

Distribution
Pseudoephedrine sulphate is presumed to cross the placenta and the haematoencephalic barrier.

The active substance is excreted in breast milk of breast-feeding women.

 



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Elimination
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 alkalinisation of the urine, a partial resorption takes place.

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, carcinogenic potential, toxicity to reproduction
and development. 

The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and 
loratadine.

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 sulphate component.

During reproductive toxicity studies, the combination of loratadine/pseudoephedrine sulphate 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. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Blue, immediate-release layer
maize starch
microcrystalline cellulose
edetate disodium
citric acid
stearic acid
colorant (Indigo carmine E132 Aluminium 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 in order to protect from light.

 



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6.5 Nature and contents of container

Aerinaze is supplied in blisters comprised of laminate blister film and foil lidding.
The blister consists of clear polychlorotrifluorethylene/polyvinyl chloride (PCTFE/PVC) film, sealed 
with a vinyl heat seal coated aluminium 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 

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER 

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/399/001
EU/1/07/399/002
EU/1/07/399/003
EU/1/07/399/004
EU/1/07/399/005
EU/1/07/399/006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 30 July 2007
Date of latest renewal: 30 July 2012

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 



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ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

SP Labo N.V. 
Industriepark 30
2220 Heist-op-den-Berg
Belgium

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk Management Plan (RMP)

Not applicable.

 



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ANNEX III

LABELLING AND PACKAGE LEAFLET

 



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A. LABELLING

 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Aerinaze 2.5 mg/120 mg modified-release tablets
desloratadine/pseudoephedrine sulphate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

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.
Read the package leaflet before use.
Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



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9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.
Keep the blisters in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

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

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aerinaze

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



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18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:
SN:
NN:

 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aerinaze 2.5 mg/120 mg modified-release tablets
desloratadine/pseudoephedrine sulphate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

 



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B. PACKAGE LEAFLET

 



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Package leaflet: Information for the patient

Aerinaze 2.5 mg/120 mg modified-release tablets
desloratadine/pseudoephedrine sulphate

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs or illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet: 
1. What Aerinaze is and what it is used for
2. What you need to know before you take Aerinaze
3. How to take Aerinaze 
4. Possible side effects
5. How to store Aerinaze
6. Contents of the pack and other information

1. What Aerinaze is and what it is used for

What Aerinaze is
Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an 
antihistamine and pseudoephedrine sulphate which is a decongestant. 

How Aerinaze works
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
(blocked/stuffy nose).

When Aerinaze should be used
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 in adults and 
adolescents 12 years of age and older.

2. What you need to know before you take Aerinaze

Do not take Aerinaze:
- if you are allergic to desloratadine, pseudoephedrine sulphate, adrenergic medicines, or any of 

the other ingredients of this medicine (listed in section 6) or to loratadine
- if you have high blood pressure, heart or blood vessel disease or a history of stroke
- if you have glaucoma, difficulty in urinating, urinary tract blockage, or an overactive thyroid
- if you are taking monoamine oxidase (MAO) inhibitor (a class of antidepressant medicines) 

therapy or have stopped taking these types of medicines within the last 14 days.

Warnings and precautions
Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine sulphate
contained in this medicine. Talk to your doctor, pharmacist or nurse before taking Aerinaze:
- if you are 60 years of age or older. Older adults may be more sensitive to the effects of this 

medicine
- if you have diabetes

 



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- if you have intestinal ulcers leading to the narrowing of the stomach, small intestine or 
esophagus (stenosing peptic ulcer)

- if you have intestinal blockage (pyloral or duodenal blockage) 
- if you have bladder neck blockage (vesical cervix blockage)
- if you have a history of difficulty breathing due to tightening of the lung muscles

(bronchospasm)
- if you have problems with your liver, kidney, or bladder.

In addition, if you experience or are diagnosed with any of the following conditions you should talk to 
your doctor, pharmacist or nurse as they 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 have medical of familial history of seizures
- severe skin reactions, including signs and symptoms such as reddening of the skin, many small 

pimples, with or without fever 

If you are scheduled to have surgery, your doctor may advise you to stop taking Aerinaze 24 hours
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. Continuous use may lead to taking more 
Aerinaze than the recommended dose to get the desired effect, resulting in an increased risk of 
overdosing. If you suddenly stop treatment, depression may occur.

Laboratory tests
Stop taking Aerinaze at least 48 hours before you have any skin tests since antihistamines may
influence the result of the skin test.
Athletes taking Aerinaze may have positive doping-tests.

Use in children and adolescents
Do not give this medicine to children less than 12 years of age.

Other medicines and Aerinaze
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. 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 by oral or nasal route (such as phenylpropanolamine, phenylephrine, ephedrine, 

oxymetazoline, naphazoline)
- diet pills (appetite suppressants)
- amphetamines
- medicines for migraines e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or 

methylergometrine)
- 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.
- tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine, 

fexofenadine)

Aerinaze with alcohol
Speak with your doctor, pharmacist or nurse regarding whether you can drink alcohol while taking 
Aerinaze. Drinking alcohol while taking Aerinaze is not recommended.

 



23

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor, pharmacist or nurse for advice before taking this medicine.
Taking Aerinaze is not recommended if you are pregnant.

Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a 
component of Aerinaze. Desloratadine and pseudoephedrine sulphate are both excreted in human 
milk. If you are breast-feeding taking Aerinaze is not recommended.

Fertility
There is no data available on male/female fertility.

Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use 
machines. Although most people do not experience drowsiness, it is recommended not to engage in 
activities requiring mental alertness, such as driving a car or operating machinery until you have 
established your own response to the medicinal product.

3. How to take Aerinaze

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 
doctor, pharmacist or nurse if you are not sure.

Adults and adolescents 12 years of age and over
The recommended dose is one tablet twice daily with a glass of water, with or without food. 

This medicine is for oral use.
Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.

Do not take more tablets than recommended on the label. Do not take 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, pharmacist or nurse 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 stop taking Aerinaze
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The 
following side effects have been seen in studies:

 



24

Common: the following may affect up to 1 in 10 people

 fast heartbeat
 restlessness with increased 

body movement
 dry mouth
 dizziness
 sore throat

 decreased appetite
 constipation

 tiredness 
 headache
 trouble sleeping
 nervousness
 drowsiness

Uncommon: the following may affect up to 1 in 100 people

 pounding or irregular heart 
beat

 increased body movement
 flushing
 hot flush
 confusion
 blurry vision
 dry eye
 nose bleeds
 irritated nose 
 inflammation of the nose
 runny nose
 inflammation of the sinus

 dry throat
 stomach ache
 stomach flu
 feeling sick (nausea)
 abnormal stool
 painful or difficult 

urination
 sugar in urine
 increased sugar in blood
 thirst
 problems urinating
 changes in frequency of 

urination

 itching
 chills
 decreased sense of smell
 abnormal liver function tests
 agitation
 anxiety
 irritability

Very rarely: the following other side effects reported during the marketing of desloratadine, may 
affect up to 1 in 10,000 people

 severe allergic reactions 
(difficulty in breathing, 
wheezing, itching, hives and 
swelling) 

 rash 

 vomiting
 diarrhoea
 hallucination

 muscle pain
 convulsion
 liver inflammation
 abnormal liver function tests

Not known: frequency cannot be estimated from the available data
 abnormal behaviour  aggression  changes in the way the heart

beats 
 weight increased, increased 

appetite

Cases of severe skin reactions, including signs and symptoms such as fever, reddening of the skin, or 
many small pimples, have been reported with pseudoephedrine-containing products.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.

5. How to store Aerinaze

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and blister after 
EXP. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


25

The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the blisters in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Aerinaze contains
- The active substances are desloratadine and pseudoephedrine sulphate.
- Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate. 
- The other ingredients are:

- Ingredients in the blue, immediate-release layer: maize starch, microcrystalline 
cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132, 
Aluminum lake).

- Ingredients in the white, sustained-release layer: hypromellose 2208, microcrystalline 
cellulose, povidone K30, silicon dioxide and magnesium stearate.

What Aerinaze looks like and contents of the pack

Aerinaze is a blue and white oval bilayer modified-release tablet with “D12” debossed in 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:
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

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
MSD Belgium BVBA/SPRL
Tél/Tel : +32 (0)2 776 62 11
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5 278 02 47
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel : +32 (0)2 776 62 11
dpoc_belux@merck.com

 



26

Česká republika
Merck Sharp & Dohme s.r.o.
Tel: +420 233 010 111 
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888-5300
hungary_msd@merck.com

Danmark
Organon Denmark ApS 
Tlf: + 45 4484 6800
info.denmark@organon.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000

(+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel: + 372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H. 
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Organon Salud, S.L.
Tel: +34 91 591 12 79

Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
Organon France
Tél: + 33 (0) 1 57 77 32 00

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 214465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel.: + 40 21 529 2900
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila 
d.o.o.
Tel: +386 1 5204 201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 70 00

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: +421 2 58282010
dpoc_czechslovak@merck.com

 



27

Italia
MSD Italia S.r.l. 
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: + 358 (0)9 804 650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited. 
Τηλ.: 800 00 673

(+357 22866700) 
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67364224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@msd.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET