البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
desloratadine
Actavis Group PTC ehf
R06AX27
desloratadine
Antihistamines for systemic use,
Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Treatment of allergic rhinitis and urticaria.
Revision: 16
Authorised
2012-01-13
22 B. PACKAGE LEAFLET 23 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 AC اقرأ الوثيقة كاملة
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. 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). Desloratad اقرأ الوثيقة كاملة