Azomyr

1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



2

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 5 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg desloratadine.

Excipient(s) with known effect:
This medicine contains lactose. 

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Azomyr is indicated in adults and adolescents aged 12 years and older for the relief of symptoms 
associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

4.2 Posology and method of administration

Posology
Adults and adolescents (12 years of age and over)
The recommended dose of Azomyr is one tablet once a day.

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. 

Paediatric population
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).

The safety and efficacy of Azomyr 5 mg film-coated tablets in children below the age of 12 years 
have not been established.

Method of administration
Oral use.
The dose can be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

 



3

4.4 Special warnings and precautions for use

In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).

Desloratadine should be administered with caution in patients with medical or familial history of 
seizures, and mainly young children (see section 4.8), 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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or 
glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which 
erythromycin or ketoconazole were co-administered (see section 5.1).

Paediatric population
Interaction studies have only been performed in adults.

In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate 
the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance 
and intoxication have been reported during post-marketing use. Therefore, caution is recommended if 
alcohol is taken concomitantly.

4.6 Fertility, pregnancy and lactation

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no 
malformative nor foeto/ neonatal toxicity of desloratadine. 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 Azomyr during pregnancy.

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of 
desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman.

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

4.7 Effects on ability to drive and use machines

Azomyr has no or negligible influence on the ability to drive and use machines based on clinical trials. 
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 in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at 
the recommended dose of 5 mg daily, undesirable effects with Azomyr were reported in 3 % of 

 



4

patients in excess of those treated with placebo. The most frequent of adverse reactions reported in 
excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). 

Paediatric population
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.

Tabulated list of adverse reactions
The frequency of the clinical trial adverse reactions reported in excess of placebo and other 
undesirable effects reported during the post-marketing period are listed in the following table. 
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).

System Organ Class Frequency Adverse reactions seen with Azomyr
Metabolism and nutrition 
disorders

Not known Increased appetite

Psychiatric disorders Very rare
Not known

Hallucinations
Abnormal behaviour, aggression

Nervous system disorders Common
Very rare

Headache
Dizziness, somnolence, insomnia, 
psychomotor hyperactivity, seizures

Cardiac disorders Very rare
Not known

Tachycardia, palpitations
QT prolongation

Gastrointestinal disorders Common
Very rare

Dry mouth
Abdominal pain, nausea, vomiting, 
dyspepsia, diarrhoea

Hepatobiliary disorders Very rare

Not known

Elevations of liver enzymes, increased 
bilirubin, hepatitis
Jaundice

Skin and subcutaneous tissue 
disorders

Not known Photosensitivity

Musculoskeletal and 
connective tissue disorders

Very rare Myalgia

General disorders and 
administration site conditions

Common
Very rare

Not known

Fatigue
Hypersensitivity reactions (such as 
anaphylaxis, angioedema, dyspnoea, 
pruritus, rash, and urticaria)
Asthenia

Investigations Not known Weight increased

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an 
unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and
aggression.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in 
patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving 
desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% 
Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new 
onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute 
increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. 
(See section 4.4.)

 



5

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

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. 
Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal 
dialysis.

Symptoms
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.

Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27

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. The clinical relevance of these observations remains to be confirmed.

Clinical efficacy and safety
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. Azomyr 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 

 

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6

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, Azomyr was effective in relieving symptoms such as sneezing, nasal 
discharge and itching, as well as ocular itching, tearing and redness, and itching of palate. Azomyr 
effectively controlled symptoms for 24 hours.

Paediatric population
The efficacy of Azomyr 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.

Azomyr 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, Azomyr 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 Azomyr 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

Absorption
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.

 



7

Distribution
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. 

Biotransformation
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.

Elimination
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.

Renally impaired patients
The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was 
compared with that of healthy subjects in one single-dose study and one multiple dose study. In the 
single-dose study, the exposure to desloratadine was approximately 2 and 2.5-fold greater in subjects 
with mild to moderate and severe CRI, respectively, than in healthy subjects. In the multiple-dose 
study, steady state was reached after Day 11, and compared to healthy subjects the exposure to 
desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in 
subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax) of desloratadine and 
3-hydroxydesloratadine were not clinically relevant.

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 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.

6. PHARMACEUTICAL PARTICULARS

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

 



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6.4 Special precautions for storage

Do not store above 30°C. 
Store in the original package.

6.5 Nature and contents of container

Azomyr is supplied in blisters comprised of laminate blister film with foil lidding.
The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride 
(PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat 
(product contact surface) which is heat sealed.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBERS 

EU/1/00/157/001-013

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2001
Date of latest renewal: 15 January 2006

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.

 



9

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 2.5 mg orodispersible tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each orodispersible tablet contains 2.5 mg desloratadine.

Excipient(s) with known effect:
This medicine contains mannitol and aspartame (E951). 

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Orodispersible tablet

Light-red, flat-faced, round, speckled tablets, one side branded with “K” 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Azomyr is indicated in adults, adolescents aged 12 years and older and children aged 6 – 11 years old 
for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

4.2 Posology and method of administration 

Posology
Adults and adolescents (12 years of age and over)
The recommended dose of Azomyr is two 2.5 mg orodispersible tablets placed in the mouth once a 
day.

Paediatric population
Children 6 to 11 years of age: the recommended dose of Azomyr is one 2.5 mg orodispersible tablet 
placed in mouth once a day.

The safety and efficacy of Azomyr 2.5 mg orodispersible tablets in children below the age of 6 years 
have not been established.

There is limited clinical trial efficacy experience with the use of desloratadine in children 6 through 
11 years of age (see section 5.2).

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.

 



10

Method of administration
Oral use.
The dose can be taken with or without food.
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.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

4.4 Special warnings and precautions for use

In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2). 

Desloratadine should be administered with caution in patients with medical or familial history of 
seizures, and mainly young children (see section 4.8), 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.

This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Azomyr orodispersible tablet. 
Phenylalanine may be harmful for people with phenylketonuria.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which 
erythromycin or ketoconazole were co-administered (see section 5.1). 

Paediatric population
Interaction studies have only been performed in adults.

In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate 
the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance 
and intoxication have been reported during post-marketing use. Therefore, caution is recommended if 
alcohol is taken concomitantly.

4.6 Fertility, pregnancy and lactation

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no 
malformative nor foeto/ neonatal toxicity of desloratadine. 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 Azomyr during pregnancy.

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of 
desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman.

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

 



11

4.7 Effects on ability to drive and use machines

Azomyr has no or negligible influence on the ability to drive and use machines based on clinical 
trials. 
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, desloratadine in the syrup formulation was administered to a paediatric population. 
The overall incidence of adverse reactions 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 Azomyr 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 %). 

Paediatric population
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.

Tabulated list of adverse reactions
The frequency of the clinical trial adverse reactions reported in excess of placebo and other 
undesirable effects reported during the post-marketing period are listed in the following table. 
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).

System Organ Class Frequency Adverse reactions seen with Azomyr
Metabolism and nutrition 
disorders

Not known Increased appetite

Psychiatric disorders Very rare
Not known

Hallucinations
Abnormal behaviour, aggression

Nervous system disorders Common
Very rare

Headache
Dizziness, somnolence, insomnia, 
psychomotor hyperactivity, seizures

Cardiac disorders Very rare
Not known

Tachycardia, palpitations
QT prolongation

Gastrointestinal disorders Common
Very rare

Dry mouth
Abdominal pain, nausea, vomiting, 
dyspepsia, diarrhoea

Hepatobiliary disorders Very rare

Not known

Elevations of liver enzymes, increased 
bilirubin, hepatitis
Jaundice

Skin and subcutaneous tissue 
disorders

Not known Photosensitivity

Musculoskeletal and 
connective tissue disorders

Very rare Myalgia

 



12

System Organ Class Frequency Adverse reactions seen with Azomyr
General disorders and 
administration site conditions

Common
Very rare

Not known

Fatigue
Hypersensitivity reactions (such as 
anaphylaxis, angioedema, dyspnoea, 
pruritus, rash, and urticaria)
Asthenia

Investigations Not known Weight increased

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an 
unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and
aggression.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in 
patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving 
desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% 
Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new 
onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute 
increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. 
(See section 4.4.)

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

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. 
Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal 
dialysis.

Symptoms
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.

Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27

 

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13

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. The clinical relevance of these observations remains to be confirmed.

Clinical efficacy and safety
In a multiple dose trial, Azomyr orodispersible tablets were well tolerated.

At the recommended dose, Azomyr 5 mg orodispersible tablet was found to be bioequivalent to the 
Azomyr 5 mg conventional tablet formulation of desloratadine. Therefore, the efficacy of Azomyr 
orodispersible tablet is expected to be the same as with the Azomyr 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. Azomyr 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, Azomyr 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. Azomyr tablets effectively controlled symptoms for 24 hours.

Paediatric population
The efficacy of Azomyr 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.

Azomyr 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. 

 



14

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, Azomyr 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 Azomyr 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 

Absorption
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.

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. There is no evidence of 
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 
20 mg) for 14 days. 

Biotransformation
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.

In single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg 
conventional tablets, the formulations were bioequivalent. Azomyr 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 Azomyr orodispersible tablets supports the use of the 2.5 mg dose in 
paediatric patients 6 to 11 years of age.

Elimination
The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax 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 effect on the bioavailability of Azomyr orodispersible tablets.

 



15

Renally impaired patients
The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was 
compared with that of healthy subjects in one single-dose study and one multiple dose study. In the 
single-dose study, the exposure to desloratadine was approximately 2 and 2.5-fold greater in subjects 
with mild to moderate and severe CRI, respectively, than in healthy subjects. In the multiple-dose 
study, steady state was reached after Day 11, and compared to healthy subjects the exposure to 
desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in 
subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax) of desloratadine and 
3-hydroxydesloratadine were not clinically relevant.

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 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 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. PHARMACEUTICAL PARTICULARS

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.

 



16

6.5 Nature and contents of container

Azomyr 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. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBERS 

EU/1/00/157/035-046

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2001
Date of latest renewal: 15 January 2006

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.

 



17

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 5 mg orodispersible tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each orodispersible tablet contains 5 mg desloratadine.

Excipient(s) with known effect:
This medicine contains mannitol and aspartame (E951). 

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Orodispersible tablet

Light-red, flat-faced, round, speckled tablets, one side branded with “A” 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Azomyr is indicated in adults and adolescents aged 12 years and older for the relief of symptoms 
associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

4.2 Posology and method of administration 

Posology
Adults and adolescents (12 years of age and over)
The recommended dose of Azomyr is one 5 mg orodispersible tablet placed in the mouth once a day.

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.

Paediatric population
The safety and efficacy of Azomyr 5 mg orodispersible tablets in children below the age of 12 years 
have not been established.

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).

Method of administration
Oral use.
The dose can be taken with or without food.
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 

 



18

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.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

4.4 Special warnings and precautions for use

In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2). 

Desloratadine should be administered with caution in patients with medical or familial history of 
seizures, and mainly young children (see section 4.8), 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.

This product contains 2.9 mg of phenylalanine per 5 mg dose of Azomyr orodispersible tablet. 
Phenylalanine may be harmful for people with phenylketonuria.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which 
erythromycin or ketoconazole were co-administered (see section 5.1). 

Paediatric population
Interaction studies have only been performed in adults.

In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate 
the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance 
and intoxication have been reported during post-marketing use. Therefore, caution is recommended if 
alcohol is taken concomitantly.

4.6 Fertility, pregnancy and lactation

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no 
malformative nor foeto/ neonatal toxicity of desloratadine. 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 Azomyr during pregnancy.

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of 
desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman.

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

4.7 Effects on ability to drive and use machines

Azomyr has no or negligible influence on the ability to drive and use machines based on clinical trials. 
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.

 



19

4.8 Undesirable effects

Summary of the safety profile
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 Azomyr tablets were reported in 3 % of 
patients in excess of those treated with placebo. The most frequent of adverse reactions reported in 
excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). 

Paediatric population
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.

Tabulated list of adverse reactions
The frequency of the clinical trial adverse reactions reported in excess of placebo and other 
undesirable effects reported during the post-marketing period are listed in the following table. 
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).

System Organ Class Frequency Adverse reactions seen with Azomyr
Metabolism and nutrition 
disorders

Not known Increased appetite

Psychiatric disorders Very rare
Not known

Hallucinations
Abnormal behaviour, aggression

Nervous system disorders Common
Very rare

Headache
Dizziness, somnolence, insomnia, 
psychomotor hyperactivity, seizures

Cardiac disorders Very rare
Not known

Tachycardia, palpitations
QT prolongation

Gastrointestinal disorders Common
Very rare

Dry mouth
Abdominal pain, nausea, vomiting, 
dyspepsia, diarrhoea

Hepatobiliary disorders Very rare

Not known

Elevations of liver enzymes, 
increased bilirubin, hepatitis
Jaundice

Skin and subcutaneous tissue 
disorders

Not known Photosensitivity

Musculoskeletal and 
connective tissue disorders

Very rare Myalgia

General disorders and 
administration site conditions

Common
Very rare

Not known

Fatigue
Hypersensitivity reactions (such as 
anaphylaxis, angioedema, dyspnoea, 
pruritus, rash, and urticaria)
Asthenia

Investigations Not known Weight increased

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an 
unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and
aggression.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in 
patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving 

 



20

desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% 
Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new 
onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute 
increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. 
(See section 4.4.)

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

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. 
Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal 
dialysis.

Symptoms
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.

Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27

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. The clinical relevance of these observations remains to be confirmed.

Clinical efficacy and safety
In a multiple dose trial, Azomyr orodispersible tablets were well tolerated.

At the recommended dose, Azomyr 5 mg orodispersible tablet was found to be bioequivalent to the 
Azomyr 5 mg conventional tablet formulation of desloratadine. Therefore, the efficacy of Azomyr 
orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.

 

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


21

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. Azomyr 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, Azomyr 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. Azomyr tablets effectively controlled symptoms for 24 hours.

Paediatric population
The efficacy of Azomyr 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.

Azomyr 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, Azomyr 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 Azomyr also significantly reduced interference with sleep and daytime 
function, as measured by a four-point scale used to assess these variables.

 



22

5.2 Pharmacokinetic properties 

Absorption
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 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. There is no evidence of 
clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 
20 mg) for 14 days. 

Biotransformation
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.

In single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg 
conventional tablets, the formulations were bioequivalent. 

Elimination
The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax 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 effect on the bioavailability of Azomyr orodispersible tablets.

Renally impaired patients
The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was 
compared with that of healthy subjects in one single-dose study and one multiple dose study. In the 
single-dose study, the exposure to desloratadine was approximately 2 and 2.5-fold greater in subjects 
with mild to moderate and severe CRI, respectively, than in healthy subjects. In the multiple-dose 
study, steady state was reached after Day 11, and compared to healthy subjects the exposure to 
desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in 
subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax) of desloratadine and 
3-hydroxydesloratadine were not clinically relevant.

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 reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction

 



23

and development. 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. PHARMACEUTICAL PARTICULARS

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

Azomyr 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

 



24

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBERS

EU/1/00/157/047-058

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2001
Date of latest renewal: 15 January 2006

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.

 



25

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 0.5 mg/ml oral solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of oral solution contains 0.5 mg desloratadine.

Excipient(s) with known effect:
This medicinal product contains 150 mg/ml of sorbitol

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Azomyr is indicated in adults, adolescents and children over the age of 1 year for the relief of 
symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

4.2 Posology and method of administration

Posology
Adults and adolescents (12 years of age and over)
The recommended dose of Azomyr is 10 ml (5 mg) oral solution once a day.

Paediatric population
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 Azomyr.

Children 1 through 5 years of age: 2.5 ml (1.25 mg) Azomyr oral solution once a day.

Children 6 through 11 years of age: 5 ml (2.5 mg) Azomyr oral solution once a day.

The safety and efficacy of Azomyr 0.5 mg/ml oral solution in children below the age of 1 year have 
not been established.

There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 
11 years of age and 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. 

 



26

Method of administration
Oral use.
The dose can be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine. 

4.4 Special warnings and precautions for use

Desloratadine should be administered with caution in patients with medical or familial history of 
seizures, and mainly young children (see section 4.8), 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.

Paediatric population
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, Azomyr 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.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which 
erythromycin or ketoconazole were co-administered (see section 5.1). 

Paediatric population
Interaction studies have only been performed in adults.

In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate 
the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance 
and intoxication have been reported during post-marketing use. Therefore, caution is recommended if 
alcohol is taken concomitantly.

4.6 Fertility, pregnancy and lactation

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no 
malformative nor foeto/ neonatal toxicity of desloratadine. 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 Azomyr during pregnancy.

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of 
desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue 

 



27

breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman.

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

4.7 Effects on ability to drive and use machines

Azomyr has no or negligible influence on the ability to drive and use machines based on clinical trials.
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

Paediatric population
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 reactions 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.

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.

Adults and adolescents
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 Azomyr 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 %). 

Tabulated list of adverse reactions
The frequency of the clinical trial adverse reactions reported in excess of placebo and other 
undesirable effects reported during the post-marketing period are listed in the following table. 
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).

 



28

System Organ Class Frequency Adverse reactions seen with Azomyr
Metabolism and nutrition 
disorders

Not known Increased appetite

Psychiatric disorders Very rare
Not known

Hallucinations
Abnormal behaviour, aggression

Nervous system disorders Common
Common (children less 

than 2 years)
Very rare

Headache
Insomnia

Dizziness, somnolence, insomnia, 
psychomotor hyperactivity, seizures

Cardiac disorders Very rare
Not known

Tachycardia, palpitations
QT prolongation

Gastrointestinal disorders Common
Common (children less 

than 2 years)
Very rare

Dry mouth
Diarrhoea

Abdominal pain, nausea, vomiting, 
dyspepsia, diarrhoea 

Hepatobiliary disorders Very rare

Not known

Elevations of liver enzymes, increased 
bilirubin, hepatitis
Jaundice

Skin and subcutaneous tissue 
disorders

Not known Photosensitivity

Musculoskeletal and 
connective tissue disorders

Very rare Myalgia

General disorders and 
administration site conditions

Common
Common (children less 

than 2 years)
Very rare

Not known

Fatigue
Fever

Hypersensitivity reactions (such as 
anaphylaxis, angioedema, dyspnoea, 
pruritus, rash, and urticaria)
Asthenia

Investigations Not known Weight increased

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an 
unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and 
aggression.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in 
patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving
desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% 
Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new 
onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute 
increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. 
(See section 4.4.)

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.

 

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


29

4.9 Overdose

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. 
Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal 
dialysis.

Symptoms
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.

Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to 
that seen with therapeutic doses, but the magnitude of the effects can be higher.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27

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. The clinical relevance of these observations remains to be confirmed.

Clinical efficacy and safety

Paediatric population
Efficacy of Azomyr oral solution has not been investigated in separate paediatric trials. However, the 
safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as 
Azomyr oral solution, 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.

Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years 
of age.

 



30

Adults and adolescents
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 
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. Azomyr 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.

In adult and adolescent patients with allergic rhinitis, Azomyr 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. Azomyr effectively controlled symptoms for 24 hours. The efficacy of Azomyr 
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.

Azomyr 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, Azomyr 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 Azomyr also significantly reduced interference with sleep and daytime 
function, as measured by a four-point scale used to assess these variables.

 



31

5.2 Pharmacokinetic properties

Absorption
Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine 
administration in adults and adolescents. Desloratadine is well absorbed with maximum concentration 
achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The 
degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and 
a once daily dosing frequency. The bioavailability of desloratadine was dose proportional over the 
range of 5 mg to 20 mg. 

In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of 
desloratadine. The prevalence of this poor metaboliser phenotype was comparable for adult (6 %) and 
paediatric subjects 2- to 11-year old (6 %), and greater among Blacks (18 % adult, 16 % paediatric) 
than Caucasians (2 % adult, 3 % paediatric) in both populations.

In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult 
subjects, four subjects were found to be poor metabolisers of desloratadine. These subjects had a Cmax
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 
Cmax 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.

In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC 
and Cmax values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.

Distribution
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 Azomyr 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.

Biotransformation
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.

Elimination
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.

Renally impaired patients
The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was 
compared with that of healthy subjects in one single-dose study and one multiple dose study. In the 
single-dose study, the exposure to desloratadine was approximately 2 and 2.5-fold greater in subjects 
with mild to moderate and severe CRI, respectively, than in healthy subjects. In the multiple-dose 

 



32

study, steady state was reached after Day 11, and compared to healthy subjects the exposure to 
desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in 
subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax) of desloratadine and 
3-hydroxydesloratadine were not clinically relevant.

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 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.

6. PHARMACEUTICAL PARTICULARS

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

Azomyr 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.

 



33

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBERS 

EU/1/00/157/059-067

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2001
Date of latest renewal: 15 January 2006

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.

 



34

ANNEX II

A. MANUFACTURERSRESPONSIBLE 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

 



35

A. MANUFACTURIERS 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 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 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 marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and 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)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP.

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time.

 



36

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



37

A. LABELLING

 



38

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 5 mg film-coated tablets
desloratadine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg desloratadine.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet 
2 film-coated tablets
3 film-coated tablets
5 film-coated tablets
7 film-coated tablets
10 film-coated tablets
14 film-coated tablets
15 film-coated tablets
20 film-coated tablets
21 film-coated tablets
30 film-coated tablets
50 film-coated tablets
100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablet whole with water.
Oral use
Read the package leaflet before use.

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

Keep out of the sight and reach of children.

 



39

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

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/1/00/157/001 1 tablet
EU/1/00/157/002 2 tablets
EU/1/00/157/003 3 tablets
EU/1/00/157/004 5 tablets
EU/1/00/157/005 7 tablets
EU/1/00/157/006 10 tablets
EU/1/00/157/007 14 tablets
EU/1/00/157/008 15 tablets
EU/1/00/157/009 20 tablets
EU/1/00/157/010 21 tablets
EU/1/00/157/011 30 tablets
EU/1/00/157/012 50 tablets
EU/1/00/157/013 100 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

 



40

16. INFORMATION IN BRAILLE

Azomyr

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN: 
NN: 

 



41

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 5 mg tablet
desloratadine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

 



42

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 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.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

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 SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



43

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

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/1/00/157/035 5 orodispersible tablets
EU/1/00/157/036 6 orodispersible tablets
EU/1/00/157/037 10 orodispersible tablets
EU/1/00/157/038 12 orodispersible tablets
EU/1/00/157/039 15 orodispersible tablets
EU/1/00/157/040 18 orodispersible tablets
EU/1/00/157/041 20 orodispersible tablets
EU/1/00/157/042 30 orodispersible tablets
EU/1/00/157/043 50 orodispersible tablets
EU/1/00/157/044 60 orodispersible tablets
EU/1/00/157/045 90 orodispersible tablets
EU/1/00/157/046 100 orodispersible tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Azomyr 2.5 mg orodispersible tablet

 



44

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN: 
NN: 

 



45

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 2.5 mg orodispersible tablets
desloratadine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP 

4. BATCH NUMBER

Lot

5. OTHER

 



46

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 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.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

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 SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



47

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

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/1/00/157/047 5 orodispersible tablets
EU/1/00/157/048 6 orodispersible tablets
EU/1/00/157/049 10 orodispersible tablets
EU/1/00/157/050 12 orodispersible tablets
EU/1/00/157/051 15 orodispersible tablets
EU/1/00/157/052 18 orodispersible tablets
EU/1/00/157/053 20 orodispersible tablets
EU/1/00/157/054 30 orodispersible tablets
EU/1/00/157/055 50 orodispersible tablets
EU/1/00/157/056 60 orodispersible tablets
EU/1/00/157/057 90 orodispersible tablets
EU/1/00/157/058 100 orodispersible tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Azomyr 5 mg orodispersible tablet

 



48

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN: 
NN: 

 



49

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Azomyr 5 mg orodispersible tablets
desloratadine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP 

4. BATCH NUMBER

Lot

5. OTHER

 



50

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. NAME OF THE MEDICINAL PRODUCT

Azomyr 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

Contains propylene glycol and sorbitol.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

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 SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 



51

8. EXPIRY DATE

EXP 

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

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/1/00/157/059 30 ml with 1 spoon
EU/1/00/157/060 50 ml with 1 spoon
EU/1/00/157/061 60 ml with 1 spoon
EU/1/00/157/062 100 ml with 1 spoon
EU/1/00/157/063 120 ml with 1 spoon
EU/1/00/157/064 150 ml with 1 spoon
EU/1/00/157/067 150 ml with 1 oral syringe
EU/1/00/157/065 225 ml with 1 spoon
EU/1/00/157/066 300 ml with 1 spoon

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Azomyr

17. UNIQUE IDENTIFIER – 2D BARCODE

 



52

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN: 
NN: 

 



53

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Azomyr 0.5 mg/ml oral solution
desloratadine

2. METHOD OF ADMINISTRATION

Oral use

3. EXPIRY DATE

EXP 

4. BATCH NUMBER

Lot

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

Contains propylene glycol and sorbitol.
See leaflet for further information.

7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

 



54

8. 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.

9. SPECIAL STORAGE CONDITIONS

Do not freeze. Store in the original package.

 



55

B. PACKAGE LEAFLET

 



56

Package leaflet: Information for the patient

Azomyr 5 mg film-coated tablets
desloratadine

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

1. What Azomyr is and what it is used for

What Azomyr is
Azomyr contains desloratadine which is an antihistamine.

How Azomyr works
Azomyr is an antiallergy medicine that does not make you drowsy. It helps control your allergic 
reaction and its symptoms.

When Azomyr should be used
Azomyr relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages 
caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 
12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and 
itchy, red or watery eyes. 

Azomyr 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. What you need to know before you take Azomyr

Do not take Azomyr
- if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in 

section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Azomyr:
- if you have poor kidney function.
- if you have medical or familial history of seizures.

 



57

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

Other medicines and Azomyr
There are no known interactions of Azomyr with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Azomyr with food, drink and alcohol
Azomyr may be taken with or without a meal. 
Use caution when taking Azomyr with alcohol.

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 or pharmacist for advice before taking this medicine.
Taking Azomyr is not recommended if you are pregnant or nursing a baby.
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. 

Azomyr contains lactose
Azomyr 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 Azomyr

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

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

This medicine is for oral use.
Swallow the tablet whole.

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 Azomyr.
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.

 



58

If you take more Azomyr than you should
Take Azomyr only as it is prescribed for you. No serious problems are expected with accidental 
overdose. However, if you take more Azomyr than you were told to, tell your doctor, pharmacist or 
nurse immediately.

If you forget to take Azomyr
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 Azomyr
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.

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, 
itching, hives and swelling) have been reported very rarely. If you notice any of these serious side 
effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies 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.

In clinical studies with Azomyr, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people
● fatigue
● dry mouth
● headache

Adults
During the marketing of Azomyr, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people
● severe allergic reactions ● rash ● pounding or irregular heartbeat
● fast heartbeat ● stomach ache ● feeling sick (nausea)
● vomiting ● upset stomach ● diarrhoea
● dizziness ● drowsiness ● inability to sleep
● muscle pain ● hallucinations ● seizures
● restlessness with increased ● liver inflammation ● abnormal liver function tests
   body movement

Not known: frequency cannot be estimated from the available data
● unusual weakness ● yellowing of the skin and/or eyes
● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to 
UV lights of a solarium
● changes in the way the heart beats
● abnormal behaviour
● aggression
● weight increased, increased appetite

Children
Not known: frequency cannot be estimated from the available data
● slow heartbeat ● change in the way the heart beats

 



59

● abnormal behaviour ● aggression

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 Azomyr

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 carton and blister after EXP. The 
expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the tablets.

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 Azomyr 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 Azomyr looks like and contents of the pack

Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 
50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: 
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 medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:

 

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


60

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
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)27766211
dpoc_belux@merck.com

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
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.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
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

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

France
MSD France
Tél: + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
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 

 



61

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

Italia
ESSEX 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@merck.com

This leaflet was last revised in

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

 



62

Package leaflet: Information for the patient

Azomyr 2.5 mg orodispersible tablets
desloratadine

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 of 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 Azomyr orodispersible tablet is and what it is used for
2. What you need to know before you take Azomyr orodispersible tablet
3. How to take Azomyr orodispersible tablet
4. Possible side effects
5. How to store Azomyr orodispersible tablet
6. Contents of the pack and other information

1. What Azomyr orodispersible tablet is and what it is used for

What Azomyr is
Azomyr contains desloratadine which is an antihistamine.

How Azomyr works
Azomyr orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps 
control your allergic reaction and its symptoms.

When Azomyr should be used
Azomyr 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) in adults,
adolescents and children 6 years of age and older. These symptoms include sneezing, runny or itchy 
nose, itchy palate, and itchy, red or watery eyes. 

Azomyr 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. What you need to know before you take Azomyr orodispersible tablet

Do not take Azomyr orodispersible tablet
- if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in 

section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Azomyr:
- if you have poor kidney function.
- if you have medical or familial history of seizures.

 



63

Use in children and adolescents
Do not give this medicine to children less than 6 years of age.

Other medicines and Azomyr
There are no known interactions of Azomyr with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Azomyr orodispersible tablet with food, drink and alcohol
Azomyr orodispersible tablet does not need to be taken with water or liquid. Additionally, Azomyr 
orodispersible tablet may be taken with or without a meal. Use caution when taking Azomyr with 
alcohol.

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 or pharmacist for advice before taking this medicine. 
Taking Azomyr is not recommended if you are pregnant or nursing a baby.
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.

Azomyr orodispersible tablet contains aspartame
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for 
people with phenylketonuria.

3. How to take Azomyr orodispersible tablet

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

Adults and adolescents 12 years of age and over
The recommended dose is two tablets once a day with or without food.

This medicine is for oral use.
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. Take the dose immediately after removal from the blister.

Children from 6 to 11 years of age
The recommended dose is one tablet once a day 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 Azomyr 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.

 



64

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 Azomyr orodispersible tablet than you should
Take Azomyr orodispersible tablet only as prescribed for you. No serious problems are expected with 
accidental overdose. However, if you take more Azomyr orodispersible tablet than you were told to, 
tell your doctor, pharmacist or nurse immediately.

If you forget to take Azomyr orodispersible tablet
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 forgotten individual doses.

If you stop taking Azomyr orodispersible tablet
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. 

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, 
itching, hives and swelling) have been reported very rarely. If you notice any of these serious side 
effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies 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.

In clinical studies with Azomyr, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people
● fatigue
● dry mouth
● headache

Adults
During the marketing of Azomyr, the following side effects were reported as: 

Very rare: the following may affect up to 1 in 10,000 people
● severe allergic reactions ● rash ● pounding or irregular heartbeat
● fast heartbeat ● stomach ache ● feeling sick (nausea)
● vomiting ● upset stomach ● diarrhoea
● dizziness ● drowsiness ● inability to sleep
● muscle pain ● hallucinations ● seizures
● restlessness with increased ● liver inflammation ● abnormal liver function tests
   body movement

Not known: frequency cannot be estimated from the available data
● unusual weakness ● yellowing of the skin and/or eyes
● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to 
UV lights of a solarium
● changes in the way the heart beats
● abnormal behaviour
● aggression
● weight increased, increased appetite

 



65

Children
Not known: frequency cannot be estimated from the available data
● slow heartbeat ● change in the way the heart beats
● abnormal behaviour ● aggression

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 Azomyr orodispersible tablet

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 carton and blister after EXP. The 
expiry date refers to the last day of that month.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.

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 Azomyr 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 Azomyr orodispersible tablet looks like and contents of the pack

Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side. 
Azomyr 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: 
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 medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:

 

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


66

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
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)27766211
dpoc_belux@merck.com

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
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.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
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

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

France
MSD France
Tél: + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
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 

 



67

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 7000

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

Italia
ESSEX 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@merck.com

This leaflet was last revised in

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

 



68

Package leaflet: Information for the patient

Azomyr 5 mg orodispersible tablets
desloratadine

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 of 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 Azomyr orodispersible tablet is and what it is used for
2. What you need to know before you take Azomyr orodispersible tablet
3. How to take Azomyr orodispersible tablet
4. Possible side effects
5. How to store Azomyr orodispersible tablet
6. Contents of the pack and other information

1. What Azomyr orodispersible tablet is and what it is used for

What Azomyr is
Azomyr contains desloratadine which is an antihistamine.

How Azomyr works
Azomyr orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps 
control your allergic reaction and its symptoms.

When Azomyr should be used
Azomyr 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) in adults and 
adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy 
palate, and itchy, red or watery eyes. 

Azomyr 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. What you need to know before you take Azomyr orodispersible tablet

Do not take Azomyr orodispersible tablet
- if you are allergic to desloratadine, or any of the other ingredients of, this medicine (listed in 

section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Azomyr:
- if you have poor kidney function.
- if you have medical or familial history of seizures.

 



69

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

Other medicines and Azomyr
There are no known interactions of Azomyr with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Azomyr orodispersible tablet with food, drink and alcohol
Azomyr orodispersible tablet does not need to be taken with water or liquid. Additionally, Azomyr 
orodispersible tablet may be taken with or without a meal. Use caution when taking Azomyr with 
alcohol.

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 or pharmacist for advice before taking this medicine. 
Taking Azomyr is not recommended if you are pregnant or nursing a baby.
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.

Azomyr orodispersible tablet contains aspartame
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for 
people with phenylketonuria.

3. How to take Azomyr orodispersible tablet

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

Adults and adolescents 12 years of age and over
The recommended dose is one tablet once a day with or without food.

This medicine is for oral use.
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. 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 Azomyr 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.

 



70

If you take more Azomyr orodispersible tablet than you should
Take Azomyr orodispersible tablet only as prescribed for you. No serious problems are expected with 
accidental overdose. However, if you take more Azomyr orodispersible tablet than you were told to, 
tell your doctor, pharmacist or nurse immediately.

If you forget to take Azomyr orodispersible tablet
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 forgotten individual doses.

If you stop taking Azomyr orodispersible tablet
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. 

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, 
itching, hives and swelling) have been reported very rarely. If you notice any of these serious side 
effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies 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.

In clinical studies with Azomyr, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people
● fatigue
● dry mouth
● headache

Adults
During the marketing of Azomyr, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people
● severe allergic reactions ● rash ● pounding or irregular heartbeat
● fast heartbeat ● stomach ache ● feeling sick (nausea)
● vomiting ● upset stomach ● diarrhoea
● dizziness ● drowsiness ● inability to sleep
● muscle pain ● hallucinations ● seizures
● restlessness with increased ● liver inflammation ● abnormal liver function tests
   body movement 

Not known: frequency cannot be estimated from the available data
● unusual weakness ● yellowing of the skin and/or eyes
● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to 
UV lights of a solarium
● changes in the way the heart beats
● abnormal behaviour
● aggression
● weight increased, increased appetite

Children
Not known: frequency cannot be estimated from the available data
● slow heartbeat ● change in the way the heart beats

 



71

● abnormal behaviour ● aggression

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 Azomyr orodispersible tablet

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 carton and blister after EXP. The 
expiry date refers to the last day of that month.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.

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 Azomyr 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 Azomyr orodispersible tablet looks like and contents of the pack

Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side. 
Azomyr 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: 
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 medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:

 

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


72

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
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)27766211
dpoc_belux@merck.com

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
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.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
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

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

France
MSD France
Tél: + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
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 

 



73

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 7000

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

Italia
ESSEX 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@merck.com

This leaflet was last revised in

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

 



74

Package leaflet: Information for the patient

Azomyr 0.5 mg/ml oral solution
desloratadine

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 of 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 Azomyr oral solution is and what it is used for
2. What you need to know before you take Azomyr oral solution
3. How to take Azomyr oral solution
4. Possible side effects
5. How to store Azomyr oral solution
6. Contents of the pack and other information 

1. What Azomyr oral solution is and what it is used for

What Azomyr is
Azomyr contains desloratadine which is an antihistamine.

How Azomyr works
Azomyr oral solution is an antiallergy medicine that does not make you drowsy. It helps control your 
allergic reaction and its symptoms.

When Azomyr should be used
Azomyr 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) in adults, adolescents 
and children 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy 
palate, and itchy, red or watery eyes. 

Azomyr 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. What you need to know before you take Azomyr oral solution

Do not take Azomyr oral solution
- if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in 

section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Azomyr:
- if you have poor kidney function.
- if you have medical or familial history of seizures.

 



75

Use in children and adolescents
Do not give this medicine to children less than 1 year of age.

Other medicines and Azomyr
There are no known interactions of Azomyr with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Azomyr oral solution with food, drink and alcohol
Azomyr may be taken with or without a meal. 
Use caution when taking Azomyr with alcohol.

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 or pharmacist for advice before taking this medicine. 
Taking Azomyr oral solution is not recommended if you are pregnant or nursing a baby.
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.

Azomyr oral solution contains sorbitol
Azomyr 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 Azomyr oral solution

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

Children
Children 1 through 5 years of age: 
The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.

Children 6 through 11 years of age: 
The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once a day.

Adults and adolescents 12 years of age and over
The recommended dose is 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.

This medicine is for oral use.

Swallow the dose of oral solution and 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 Azomyr oral solution.

 



76

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 Azomyr oral solution than you should
Take Azomyr oral solution only as it is prescribed for you. No serious problems are expected with 
accidental overdose. However, if you take more Azomyr oral solution than you were told to, tell your
doctor, pharmacist or nurse immediately.

If you forget to take Azomyr oral solution
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 Azomyr oral solution
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.

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, 
itching, hives and swelling) have been reported very rarely. If you notice any of these serious side 
effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in most children and adults, side effects with Azomyr 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.

In clinical studies with Azomyr, the following side effects were reported as:

Children
Common in children less than 2 years of age: the following may affect up to 1 in 10 children
● diarrhoea
● fever 
● insomnia

Adults
Common: the following may affect up to 1 in 10 people
● fatigue
● dry mouth
● headache

During the marketing of Azomyr, the following side effects were reported as:

Adults
Very rare: the following may affect up to 1 in 10,000 people
● severe allergic reactions ● rash ● pounding or irregular heartbeat
● fast heartbeat ● stomach ache ● feeling sick (nausea)
● vomiting ● upset stomach ● diarrhoea

 



77

● dizziness ● drowsiness ● inability to sleep
● muscle pain ● hallucinations ● seizures
● restlessness with increased ● liver inflammation ● abnormal liver function tests
   body movement

Not known: frequency cannot be estimated from the available data
● unusual weakness ● yellowing of the skin and/or eyes
● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to 
UV lights of a solarium
● changes in the way the heart beats
● abnormal behaviour
● aggression
● weight increased, increased appetite

Children
Not known: frequency cannot be estimated from the available data
● slow heartbeat ● change in the way the heart beats
● abnormal behaviour ● aggression

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 Azomyr oral solution 

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

Do not freeze. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the oral solution.

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 Azomyr oral solution 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 Azomyr oral solution looks like and contents of the pack

Azomyr 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. 

 

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


78

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 medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
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)27766211
dpoc_belux@merck.com

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
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.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

 



79

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

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

France
MSD France
Tél: + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
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

Italia
ESSEX 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@merck.com

This leaflet was last revised in

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

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURIERS 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