Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
desloratadine
Ratiopharm GmbH
R06AX27
desloratadine
Antihistamines for systemic use,
Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician
Revision: 12
Authorised
2012-01-13
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESLORATADINE RATIOPHARM 5 MG FILM-COATED TABLETS desloratadine For adults READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET 1. What Desloratadine ratiopharm is and what it is used for 2. What you need to know before you take Desloratadine ratiopharm 3. How to take Desloratadine ratiopharm 4. Possible side effects 5. How to store Desloratadine ratiopharm 6. Contents of the pack and other information 1. WHAT DESLORATADINE RATIOPHARM IS AND WHAT IT IS USED FOR WHAT DESLORATADINE RATIOPHARM IS Desloratadine ratiopharm contains desloratadine which is an antihistamine. HOW DESLORATADINE RATIOPHARM WORKS Desloratadine ratiopharm is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLORATADINE RATIOPHARM SHOULD BE USED Desloratadine ratiopharm 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. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Desloratadine ratiopharm is also used to relieve the symptoms associated with chronic idiopathic urticaria (a skin condition with unknown cause), initially diagnosed by your doctor. 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. You Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Desloratadine ratiopharm 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg desloratadine. Excipient(s) with known effect: Each tablet contains 14.25 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round, biconvex, blue film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - chronic idiopathic urticaria as initially diagnosed by a physician (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one tablet once a day. Duration of treatment The duration of treatment depends on the type, duration and course of symptoms. If symptoms persist for more than 7 days or deteriorate, patients should seek medical advice in order to minimise the risk of masking an underlying disease. 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. For chronic idiopathic urticaria the symptoms may persist more than 6 weeks it is characterised by recurrent episodes and continued treatment may be necessary. _Paediatric population _ Desloratadine ratiopharm is not recommended for use in children and adolescents below 18 years of age. 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). 3 The safety and efficacy of Desloratadine Preberite celoten dokument