Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
FEXOFENADINE HYDROCHLORIDE
PHARMA SHALOM
R06AX26
FILM COATED TABLETS
FEXOFENADINE HYDROCHLORIDE 180 MG
PER OS
Not required
OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE
FEXOFENADINE
FEXOFENADINE
Relief of symptoms associated with chronic idiopathic urticaria.
2022-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor’s prescription TELFAST 180 MG, FILM COATED TABLETS _ _ _Active ingredient and its amount: _ Each tablet contains: Fexofenadine hydrochloride 180 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 the preparation according to the instructions in the dosage section in this leaflet. Consult the pharmacist if you need further information. Refer to the doctor if the symptoms of the illness worsen or are not improving after a few days. - The medicine is not intended for children under 12 years of age. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is used for relief in cases of prolonged rash accompanied by itching. 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 taking 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 heartbeat. • you are elderly. If any of these conditions 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. It is recommended that you take these me Citiți documentul complet
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 Citiți documentul complet