البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
FEXOFENADINE HYDROCHLORIDE
PHARMA SHALOM
R06AX26
FILM COATED TABLETS
FEXOFENADINE HYDROCHLORIDE 120 MG
PER OS
Not required
OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE
FEXOFENADINE
FEXOFENADINE
Relief of symptoms associated with seasonal allergic rhinitis
2022-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor's prescription TELFAST ® 120 MG, FILM COATED TABLETS _ _ _Active ingredient and its amount: _ Each tablet contains: Fexofenadine hydrochloride 120 mg _INACTIVE INGREDIENTS:_ See section 6 READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. - Keep this leaflet. You may need to read it again. - This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. - Take this preparation exactly as per the instructions in the dosage section of this leaflet or as instructed by your doctor or pharmacist. Consult the pharmacist if you need further information. Refer to the doctor if the symptoms get worse or do not improve after few days. - The medicine is not intended for children under the age of 12. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is used for relief of symptoms associated with seasonal allergic rhinitis. THERAPEUTIC GROUP: Antihistamine. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: you are sensitive (allergic) to fexofenadine or to any of the other ingredients of the medicine (see section 6). _SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE _ Before starting treatment with Telfast, consult the doctor if: • you suffer from impaired function of the: kidney or liver. • you suffer or have suffered in the past from 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. IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND FOOD SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. In particular, inform the doctor or pharmacist if you are taking medicines for digestive problems that contain aluminium or magnesium which may affect the action of Telfast by lowering the amount of Telfast absorbed. اقرأ الوثيقة كاملة
1. NAME OF THE MEDICINAL PRODUCT Telfast 120 mg film-coated tablets Telfast 180 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TELFAST 120 MG FILM-COATED TABLETS : Each tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. TELFAST 180 MG FILM-COATED TABLETS: Each tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TELFAST 120 MG FILM-COATED TABLETS: Relief of symptoms associated with seasonal allergic rhinitis. TELFAST 180 MG FILM-COATED TABLETS: Relief of symptoms associated with chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS _ TELFAST 120 MG FILM-COATED TABLETS: The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal. TELFAST 180 MG FILM-COATED TABLETS: The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. _PEDIATRIC POPULATION _ • _CHILDREN AGED 12 YEARS AND OVER_ TELFAST 120 MG FILM-COATED TABLETS: The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal. TELFAST 180 MG FILM-COATED TABLETS: The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 180 mg once daily taken before a meal. • _CHILDREN UNDER 12 YEARS OF AGE_ The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12. _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. 4.4 SPECIAL WARNINGS اقرأ الوثيقة كاملة