Desloratadine Teva

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Teva 5 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 5 mg desloratadine. 
 
Excipient(s) with known effect:  
Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
Blue, round, biconvex film-coated tablet - printed in with ink: “D5” on one side and plain on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Desloratadine Teva 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 Desloratadine Teva 5 mg film-coated tablets 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 Desloratadine Teva 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 
 



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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, Desloratadine Teva 5 mg film-coated tablets 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, desloratadine 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 Desloratadine Teva 5 mg film-coated tablets 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 Desloratadine Teva 5 mg film-coated tablets 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 
 
Desloratadine 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 



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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 desloratadine 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 

desloratadine 
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.) 
 
Reporting of suspected adverse reactions 



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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. 
Desloratadine 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. 
 

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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, desloratadine was effective in relieving symptoms such as sneezing, nasal 
discharge and itching, as well as ocular itching, tearing and redness, and itching of palate. Desloratadine 
effectively controlled symptoms for 24 hours.  
 
Paediatric population 
The efficacy of desloratadine 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. 
 
Desloratadine 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, desloratadine 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 nonresponsive 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 
desloratadine 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. 
 
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. 



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Biotransformation 
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some 
interactions with other medicinal products can not be fully excluded. Desloratadine does not inhibit CYP3A4 
in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a 
substrate nor an inhibitor of P-glycoprotein. 
 
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 
Microcrystalline cellulose 
Pregelatinised maize starch 
Talc 
Silica colloidal anhydrous 
 
Tablet coating 
Lactose monohydrate 
Hypromellose 
Titanium dioxide (E171) 
Macrogol 400 
Indigo carmine (E132) 
 
Printing ink 
Shellac 
Titanium dioxide (E171) 
Propylene glycol 
 
6.2 Incompatibilities 
 
Not applicable. 



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6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
OPA/Alu/PVC - Aluminium blisters. 
Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets. 
 
OPA/Alu/PVC - Aluminium perforated unit dose blisters. 
Pack of 50 x 1 film-coated tablet (unit dose). 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands  
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/732/001 
EU/1/11/732/002 
EU/1/11/732/003 
EU/1/11/732/004 
EU/1/11/732/005 
EU/1/11/732/006 
EU/1/11/732/007 
EU/1/11/732/008 
EU/1/11/732/009 
EU/1/11/732/010 
EU/1/11/732/011 
EU/1/11/732/012 
EU/1/11/732/013 
EU/1/11/732/014 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 November 2011 
Date of latest renewal: 8 August 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 



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

http://www.ema.europa.eu/


10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

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

 



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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
TEVA Pharmaceutical Works Private Limited Company 
Pallagi út 13 
HU-4042 Debrecen 
Hungary 
 
TEVA UK Ltd. 
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG 
United Kingdom 
 
Pharmachemie B.V. 
Swensweg 5, 2031 GA Haarlem 
The Netherlands 
 
Merckle GmbH 
Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
 
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 (PSURSs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent 
updates published on the European medicines web-portal. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
Not applicable. 
  



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
  



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



14 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Teva 5 mg film-coated tablets 
desloratadine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg desloratadine. 
 
 
3. LIST OF EXCIPIENTS 
 
It also contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
10 film-coated tablets 
14 film-coated tablets 
20 film-coated tablets 
21 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
40 film-coated tablets 
50 film-coated tablets 
50 x 1 film-coated tablet (unit dose) 
60 film-coated tablets 
90 film-coated tablets 
100 film-coated tablets 
105 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Swallow the tablet whole with water.  
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



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8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands  
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/732/001 7 film-coated tablets 
EU/1/11/732/002 10 film-coated tablets 
EU/1/11/732/003 14 film-coated tablets 
EU/1/11/732/004 20 film-coated tablets 
EU/1/11/732/005 21 film-coated tablets 
EU/1/11/732/006 28 film-coated tablets 
EU/1/11/732/007 30 film-coated tablets 
EU/1/11/732/008 40 film-coated tablets 
EU/1/11/732/009 50 film-coated tablets 
EU/1/11/732/010 60 film-coated tablets 
EU/1/11/732/011 90 film-coated tablets 
EU/1/11/732/012 100 film-coated tablets 
EU/1/11/732/013 50 x 1 film-coated tablet (unit dose) 
EU/1/11/732/014 105 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Desloratadine Teva 5 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



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2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Teva 5 mg film-coated tablets 
desloratadine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 

Teva B.V. 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



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Package leaflet: Information for the patient 
 

Desloratadine Teva 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 or pharmacist. 
- 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 or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4.  
 
 
What is in this leaflet: 
1. What Desloratadine Teva is and what it is used for 
2. What you need to know before you take Desloratadine Teva 
3. How to take Desloratadine Teva 
4. Possible side effects 
5. How to store Desloratadine Teva 
6. Contents of the pack and other information 
 
 
1. What Desloratadine Teva is and what it is used for 
 
What Desloratadine Teva is 
Desloratadine Teva contains desloratadine which is an antihistamine. 
 
How Desloratadine Teva works 
Desloratadine Teva is an antiallergy medicine that does not make you drowsy. It helps control your allergic 
reaction and its symptoms. 
 
When Desloratadine Teva should be used 
Desloratadine Teva 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. 
 
Desloratadine Teva 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 Desloratadine Teva 
 
Do not take Desloratadine Teva 
• 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 or pharmacist before taking Desloratadine Teva 
• if you have poor kidney function. 
• if you have medical or familial history of seizures. 
 



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Use in children and adolescents 
 Do not give this medicine to children less than 12 years of age. 
 
Other medicines and Desloratadine Teva 
There are no known interactions of Desloratadine Teva with other medicines. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
Desloratadine Teva with food, drink and alcohol 
Desloratadine Teva may be taken with or without a meal.  
Use caution when taking Desloratadine Teva 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 Desloratadine Teva 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. 
 
Desloratadine Teva contains lactose 
Desloratadine Teva contains lactose. If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicine. 
 
 
3. How to take Desloratadine Teva 
 
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 doctor will determine the type of allergic rhinitis you are suffering 
from and will determine for how long you should take Desloratadine Teva. 
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 
4 weeks), your doctor 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 doctor 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 doctor. 
 
If you take more Desloratadine Teva than you should 
Take Desloratadine Teva only as it is prescribed for you. No serious problems are expected with accidental 
overdose. However, if you take more Desloratadine Teva than you were told to, tell your doctor, pharmacist 
or nurse immediately. 
 



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If you forget to take Desloratadine Teva 
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 Desloratadine Teva 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
During the marketing of Desloratadine Teva, 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 desloratadine, 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 Desloratadine Teva, 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 
● abnormal behaviour   ● aggression 
 
Reporting of side effects  
 



22 

If you get any side effects, talk to your doctor or pharmacist. 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 Desloratadine Teva 
 
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. 
 
This medicinal product does not require any special storage conditions. 
 
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 protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Desloratadine Teva contains  
- The active substance is 5 mg desloratadine. 
- The other ingredients are microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal 

anhydrous, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo 
carmine (E132), shellac and propylene glycol. 

 
What Desloratadine Teva looks like and contents of the pack 
Blue, round, biconvex film-coated tablet - printed in with ink: “D5” on one side and plain on the other. 
Desloratadine Teva 5 mg film-coated tablets are supplied in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 
60, 90, 100 and 105 film-coated tablets and in perforated blister packs of 50 x 1 film-coated tablet (unit 
dose). Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer  
 
Marketing Authorisation Holder 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturer 
TEVA Pharmaceutical Works Private Limited Company 
Pallagi út 13, 
4042 Debrecen, 
Hungary 
 
or 
 
TEVA UK Ltd 
Brampton Road, Hampden Park, Eastbourne, 
East Sussex, BN22 9AG, 
United Kingdom 
 
or 
 

http://www.google.co.uk/url?url=http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc&rct=j&frm=1&q=&esrc=s&sa=U&ei=aaztVLTSMOSc7gbJq4DAAg&ved=0CBYQFjAA&sig2=yzUOL4Px9reyQdo7yLkGLA&usg=AFQjCNH3PGeyMuvF5o4tqk4n9r4W0dgBIQ


23 

Pharmachemie B.V. 
Swensweg 5, 
2031 GA Haarlem, 
The Netherlands 
 
or 
 
Merckle GmbH 
Ludwig-Merckle-Strasse 3 
D-89143 Blaubeuren 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Teva Pharma Belgium N.V./S.A./AG 
Belgique/Belgien 
Tél/Tel: +32 38207373 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 19127700 
 

Deutschland 
TEVA GmbH 
Tel: +49 73140208 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 8000228400 
 

Eesti 
 
UAB Teva Baltics Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Teva Pharma, S.L.U. 
Tel: +34 913873280 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Teva Santé 
Tél: +33 155917800 
 

Portugal 
Teva Pharma - Produtos Farmacêuticos Lda. 
Tel: +351 214767550 
 



24 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: + 385 13720000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +4021 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 19127700 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Teva Finland Oy 
Finnland 
Sími: +358 201805900 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 028917981 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Teva Ελλάς Α.Ε. 
Ελλάδα 
Τηλ: +30 211 880 5000 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Teva Baltics filiāle Latvijā  
Tel: +371 67323666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 
 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS 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