Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
desloratadine
Denk Pharma GmbH & Co. KG
R06AX27
desloratadine
5mg
tablets film-coated
(10/1x10/) blister
Prescription
Registered
2015-05-15
_Deslora-Denk 5_ Film-coated tablet – oral use Antiallergic / antihistaminic agent Active substance: desloratadine Package leaflet: Information for the user 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 DESLORA-DENK 5 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORA-DENK 5 3. HOW TO TAKE DESLORA-DENK 5 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DESLORA-DENK 5 6. CONTENTS OF THE PACK AND OTHER INFOR- MATION 1. What Deslora-Denk 5 is and what it is used for What Deslora-Denk 5 is Deslora-Denk 5 contains desloratadine which is an antihistamine. How Deslora-Denk 5 works Deslora-Denk 5 is an antiallergy medicine that does not make you drowsy. It helps con- trol your allergic reaction and its symptoms. When Deslora-Denk 5 should be used Deslora-Denk 5 relieves symptoms associat- ed with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for ex- ample, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, run- ny or itchy nose, itchy palate, and itchy, red or watery eyes. Deslora-Denk 5 is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symp- toms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activ- ities and sleep. 2. What you need to know before you take Deslora-Denk 5 Do not take Deslora-Denk 5 • if you are allergic to desloratadine, or any of the Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Deslora-Denk 5 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: desloradine Each tablet contains 5 mg desloratadine. Excipient(s) with known effect : each film-coated tablet contains 12 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Blue, round film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deslora-Denk 5 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 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 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. 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). Patients with rare hereditary problems of galactose intolerance, the Les hele dokumentet