البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
KETOTIFEN AS FUMARATE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
R06AX
SYRUP
KETOTIFEN AS FUMARATE 1 MG / 5 ML
PER OS
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
OTHER ANTIHISTAMINES FOR SYSTEMIC USE
Prophylactic treatment of bronchial asthma. Symptomatic treatment of allergic conditions including bronchitis, rhinitis, hay fever and urticaria.
2021-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. PROFITEN TABLETS EACH TABLET CONTAINS: KETOTIFEN (AS FUMARATE) 1 MG PROFITEN SYRUP EACH TEASPOON (5 ML) OF SYRUP CONTAINS: KETOTIFEN (AS FUMARATE) 1 MG Inactive and allergenic ingredients in the preparation - see section 6 in the leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The tablets are not intended for children under the age of 3. The syrup is not intended for children under 6 months of age. 1. WHAT IS THE MEDICINE INTENDED FOR? As a prophylactic treatment of bronchial asthma. For symptomatic treatment of allergic conditions such as: bronchitis, rhinitis, hay fever, and skin rash )urticaria(. THERAPEUTIC GROUP: Other antihistamines for systemic treatment. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: ∙ You are sensitive )allergic( to the active ingredient or to any of the additional ingredients contained in the medicine )see section 6 for a list of inactive ingredients(. ∙ You are being concomitantly treated with oral anti-diabetic preparations. SPECIAL WARNINGS REGARDING USE OF PROFITEN: Since this medicine is intended for asthma prophylaxis, it is not effective in cases of acute asthma attacks. In such cases, use other preparations. When you start treatment with Profiten, do not stop taking anti-asthma preparations you are currently using )especially preparations containing corticosteroids( without the doctor’s permission. BEFORE TREATMENT WITH PROFITEN, TELL THE DOCTOR IF: ∙ You are pregnant, planning to become pregnant or are breastfeeding. ∙ You are suffering from epilepsy. ∙ You are suffering from a hereditary اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Profiten Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 1 mg Ketotifen (as fumarate). For the full list of excipients and information on excipients with known effect, see section 4.4 and section 6.1. 3 PHARMACEUTICAL FORM Clear to slightly yellow –raspberry flavoured liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic treatment of bronchial asthma. Symptomatic treatment of allergic conditions including bronchitis, rhinitis, hay fever and urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults 1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily. Children From 3 years of age: 1 mg twice daily with food. From 6 months to 3 years of age: 1/2 mg twice daily with food Use in the elderly No evidence exists that elderly patients require different dosages or show different side-effects from younger patients. Patients known to be easily sedated should be given 0.5 -1 mg at night for the first few days. 4.3 CONTRAINDICATIONS o Hypersensitivity to ketotifen or any of the excipients listed in section 6.1. o Epilepsy o Patients being treated with oral antidiabetic agent o Breastfeeding 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 2 If intercurrent infection occurs, Profiten treatment must be supplemented by specific antimicrobial therapy. Convulsions have been reported very rarely during Profiten therapy. As Profiten may lower the seizure threshold it should be used with caution in patients with a history of epilepsy. Thrombocytopenia may occur in patients taking Profiten at the same time as oral antidiabetic drugs (biguanides). The simultaneous administration of these drugs should therefore be avoided (see section 4.3). In case of reduced attention, possibly due to the sedating effect of Profiten, the dose should be reduced. Excipients with known effect: Sucrose, sorbitol, sodium benzoate. Each 5 ml of Profiten syrup contains about: o 3 grams of sucrose. Patients with rare heredi اقرأ الوثيقة كاملة