Desloratadine Actavis

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Actavis 5 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 5 mg desloratadine. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT’ 
engraved on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Desloratadine Actavis 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 Actavis 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 Actavis 5 mg film-coated tablets in children below the age of 
12 years have not been established. No data are available.  
 
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, desloratadine 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, 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. 
 
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 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 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 
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%). 
 



4 

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. 
 
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. 

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


5 

 
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 anti-allergic properties from in vitro studies. These include inhibiting 
the release of pro-inflammatory 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. 
 
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.  



6 

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 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 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. 
 
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 



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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  
Starch, pregelatinised 
Mannitol 
Talc 
Magnesium stearate 
 
Tablet coating: 
Hypromellose 6cP 
Titanium dioxide (E171) 
Macrogol 6000 
Indigo carmine aluminum lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Blisters: 
This medicinal product does not require any special storage conditions. 
 
Bottles: 



8 

This medicinal product does not require any special temperature storage conditions. 
Keep the bottle tightly closed in order to protect from light. 
 
6.5 Nature and contents of container 
 
OPA/Aluminium/PVC–Aluminium blisters. 
Pack sizes: 7, 10, 14, 20, 21, 30, 50, 90 and 100 tablets. 
 
Polyethylene bottles containing a desiccant and closed with a polyethylene cap. 
Pack sizes: 30 and 100 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/745/001  
EU/1/11/745/002  
EU/1/11/745/003  
EU/1/11/745/004  
EU/1/11/745/005  
EU/1/11/745/006  
EU/1/11/745/007  
EU/1/11/745/008  
EU/1/11/745/009 
EU/1/11/745/010 
EU/1/11/745/011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 13.01.2012 
Date of latest renewal: 11.11.2016 
 
 
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 
  

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


9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER 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 
 
 
 



10 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
or 
 
Balkanpharma-Dupnitsa AD 
3 Samokovsko Shosse Str. 
2600 Dupnitsa 
Bulgaria 
 
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 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 

 
Not applicable. 
  



11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



13 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Actavis 5 mg film-coated tablets 
desloratadine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg desloratadine. 
 
 
3. LIST OF EXCIPIENTS 
 
 
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 
30 film-coated tablets 
50 film-coated tablets 
90 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Swallow the tablet whole with water. 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



14 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/745/001 7 film-coated tablets 
EU/1/11/745/002 10 film-coated tablets 
EU/1/11/745/003 14 film-coated tablets 
EU/1/11/745/004 20 film-coated tablets 
EU/1/11/745/005 21 film-coated tablets 
EU/1/11/745/006 30 film-coated tablets 
EU/1/11/745/007 50 film-coated tablets 
EU/1/11/745/008 90 film-coated tablets 
EU/1/11/745/009 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
desloratadine actavis 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
<Not applicable.>  
 
 



15 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
< PC: {number}  
SN: {number}  
NN: {number} > 
 
<Not applicable.> 
 



16 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Actavis 5 mg tablets 
desloratadine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



17 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOTTLE CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Actavis 5 mg film-coated tablets 
desloratadine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg desloratadine. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 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 
 
Do not swallow the desiccant. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the bottle tightly closed in order to protect from light. 
 
 



18 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/745/010 30 film-coated tablets 
EU/1/11/745/011 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
desloratadine actavis 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
<Not applicable.>  
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
< PC: {number}  
SN: {number}  
NN: {number} > 
 
<Not applicable.> 
 
  



19 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Desloratadine Actavis 5 mg film-coated tablets 
desloratadine  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg desloratadine. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 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 
 
Do not swallow the desiccant. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the bottle tightly closed in order to protect from light. 
 
 



20 

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 
 
[Actavis Group PTC ehf. Logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/745/010 30 film-coated tablets 
EU/1/11/745/011 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 

  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



22 

Package leaflet: Information for the patient 
 

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



23 

Use in children and adolescents 
Do not give this medicine to children less than 12 years of age. 
 
Other medicines and Desloratadine Actavis 
There are no known interactions of Desloratadine Actavis with other medicines. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Desloratadine Actavis with food, drink and alcohol 
Desloratadine Actavis may be taken with or without a meal. 
Use caution when taking Desloratadine Actavis 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 Actavis 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. 
 
 
3. How to take Desloratadine Actavis 
 
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 Actavis. 
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 Actavis than you should 
Take Desloratadine Actavis only as it is prescribed for you. No serious problems are expected with 
accidental overdose. However, if you take more Desloratadine Actavis than you were told to, tell your 
doctor, pharmacist or nurse immediately. 
 
If you forget to take Desloratadine Actavis 
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. 
 



24 

If you stop taking Desloratadine Actavis 
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 desloratadine, 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, 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 body 

movement 
• liver inflammation • abnormal liver function tests 

   
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 
• abnormal behaviour 

• change in the way the heart beats 
• 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. 
 

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


25 

 
5. How to store Desloratadine Actavis 
 
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, bottle label and blister 
after ‘EXP’. The expiry date refers to the last day of that month. 
 
Blisters: 
This medicine does not require any special storage conditions. 
 
Bottles: 
This medicine does not require any special temperature storage conditions. 
Keep the bottle tightly closed in order to protect from light. 
 
Tell your pharmacist 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 Actavis contains 
- The active substance is desloratadine. Each film-coated tablet (tablet) contains 5 mg 

desloratadine. 
- The other ingredients are: 
 Tablet core: Microcrystalline cellulose, starch (pregelatinised), mannitol, talc, magnesium 

stearate. Tablet coating: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo 
carmine aluminum lake (E132). 

 
What Desloratadine Actavis looks like and contents of the pack 
Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT’ 
engraved on one side. 
 
Desloratadine Actavis 5 mg film-coated tablets are packed in:  
Blister packs: 7, 10, 14, 20, 21, 30, 50, 90 or 100 tablets. 
 
Plastic bottles containing a desiccant and closed with a plastic cap: 30 or 100 tablets. 
Do not swallow the desiccant. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
or 



26 

 
Balkanpharma-Dupnitsa AD 
3 Samokovsko Shosse Str. 
2600 Dupnitsa 
Bulgaria 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Aurobindo Pharma B.V. 
Nederland / Pays-Bas / Niederlande 
Tél/Tel: +31 (0)35 542 99 33 
 

Lietuva 
UAB "Sicor Biotech" 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Aurobindo Pharma B.V. 
Pays-Bas / Niederlande 
Tél/Tel: +31 (0)35 542 99 33 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: + 420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
PUREN Pharma GmbH & Co. KG 
Telefon: +49 (0)89 558909 0 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 (0)35 542 99 33 
 

Eesti 
UAB "Sicor Biotech" Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 210 5401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 

España 
Aurovitas Spain, S.A.U. 
Tfno.: +34 91 630 86 45 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o.  
Tel: +385 1 37 20 000  
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 



27 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Aurobindo Pharma (Italia) s.r.l. 
Tel: +39 0296392601 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 (0)20 180 5900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00  
 

Latvija 
UAB "Sicor Biotech" filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271 385257 
 

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

 

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

	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 appro...
	Annex II
	A. manufacturer 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

	ANNEX III
	LABELLING AND PACKAGE LEAFLET
	Keep out of the sight and reach of children.
	Keep out of the sight and reach of children.
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
	Keep out of the sight and reach of children.
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	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
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	What is in this leaflet
	Not known: frequency cannot be estimated from the available data
	Reporting of side effects
	This leaflet was last revised in MM/YYYY