البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
FEXOFENADINE HYDROCHLORIDE
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
R06AX26
FEXOFENADINE HYDROCHLORIDE
FILM-COATED TABLET
FEXOFENADINE HYDROCHLORIDE 120 milligram(s)
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2005-11-15
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER TELFAST 120 MG FILM-COATED TABLETS FEXOFENADINE HYDROCHLORIDE 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 Telfast is and what it is used for 2. What you need to know before you take Telfast 3. How to take Telfast 4. Possible side effects 5. How to store Telfast 6. Contents of the pack and other information 1. WHAT TELFAST IS AND WHAT IT IS USED FOR Telfast contains fexofenadine hydrochloride, which is a non-drowsy antihistamine. Telfast 120 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELFAST DO NOT TAKE TELFAST • if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Telfast if: • you have problems with your liver or kidneys • you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat • you are elderly If any of these apply to you, or if you are not sure, tell your doctor before taking Telfast. OTHER MEDICINES AND TELFAST Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal pr اقرأ الوثيقة كاملة
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 1. NAME OF THE MEDICINAL PRODUCT Telfast 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Peach, modified capsule-shaped, film-coated tablet of 6.1 x 15.8 mm debossed with “012" on one side and a scripted “e” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Telfast 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. _Paediatric population _ • Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal. • Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12. In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population. _Special populations _ Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Page 3 of 7 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups (see section 4.2). Patients with a history of or ongoing car اقرأ الوثيقة كاملة