Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
desloratadine
N.V. Organon
R06AX27
desloratadine
Antihistamines for systemic use,
Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria
Revision: 46
Authorised
2001-01-15
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEOCLARITYN 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 Neoclarityn is and what it is used for 2. What you need to know before you take Neoclarityn 3. How to take Neoclarityn 4. Possible side effects 5. How to store Neoclarityn 6. Contents of the pack and other information 1. WHAT NEOCLARITYN IS AND WHAT IT IS USED FOR WHAT NEOCLARITYN IS Neoclarityn contains desloratadine which is an antihistamine. HOW NEOCLARITYN WORKS Neoclarityn is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN NEOCLARITYN SHOULD BE USED Neoclarityn 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. Neoclarityn 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 NEOCLARITYN DO NOT TAKE NEOCLARITYN - if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine. WARNINGS AND PR Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Neoclarityn 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg desloratadine. Excipient(s) with known effect This medicinal product contains lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Light blue, round and embossed film-coated tablets with elongated letters “S” and “P” on one side and plain on the other. The diameter of the film-coated tablet is 6.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neoclarityn 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 Neoclarityn 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 Neoclarityn 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. 3 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 Renal function Lesen Sie das vollständige Dokument