Country: Իսրայել
language: անգլերեն
source: Ministry of Health
PHENTERMINE AS RESINATE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
A08AA01
CAPSULES
PHENTERMINE AS RESINATE 15 MG
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
PHENTERMINE
PHENTERMINE
For the treatment of severe obesity that has not responded to an appropriate diet - a minimal body mass index of 30 kg/m2 is required.
2022-08-31
LFL 206 12/21 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only RAZIN CAPSULES Each capsule contains: Phentermine (as resinate) 15 mg Inactive ingredients and allergens in the preparation – see the section “Important information about some of the ingredients of the medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is not intended for children and adolescents under the age of 16. This medicine is usually not intended for adults over the age of 65. 1. WHAT IS THE MEDICINE INTENDED FOR? Razin is intended for the treatment of severe obesity that does not respond to appropriate dietary treatment – a minimum body mass index of 30 kg/m 2 is required. The treatment should be undertaken under medical supervision and should be based, among other things, on changes in lifestyle, exercise, controlled diet, behavioral support, etc. THERAPEUTIC CLASS: a group of preparations for weight loss that work via the central nervous system. The medicine directly affects the area in the brain that is responsible for appetite and reduces the feeling of hunger. 2. BEFORE USING RAZIN DO NOT USE THIS MEDICINE IF ANY OF THE FOLLOWING CONDITIONS APPLIES: · Sensitivity (allergy) to the active ingredient or to any of the additional ingredients the medicine contains, or to similar medicines used for weight loss. The symptoms of an allergic reaction may be: shortness of breath, wheezing or breathing difficulties, swelling of the face, lips, tongue or other areas in the body, rash, itch, hives. · In combination with other medicines for weight loss · Very high blood pressure · P read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Razin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Phentermine (as resinate) 15 mg/cap For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of severe obesity that has not responded to an appropriate diet- a minimal body mass index of 30 kg/m 2 is required. Razin is indicated as an adjunct in a medically monitored comprehensive regimen of weight reduction based on exercise, diet (caloric restriction) and behaviour modification . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children aged over 16 years: One capsules daily at breakfast, swallowed whole. Evening dosing should be avoided as this agent may induce insomnia. It is recommended that treatment should be initiated under the care of medical practitioners experienced in the treatment of obesity. Razin capsules may be used for a period of up to 3 months of treatment. Children: Razin is not recommended for children under the age of 16. Elderly: Razin is not recommended for the elderly 4.3 CONTRAINDICATIONS The use of Razin is contraindicated in cases of: hypersensitivity to phentermine, Sympathomimetic drugs or to any of the excipients listed in section 6.1 Pulmonary artery hypertension Existing heart valve abnormalities or heart murmurs Moderate to severe arterial hypertension Cerebrovascular disease Severe cardiac disease including arrhythmias, Advanced arteriosclerosis Hyperthyroidism Agitated states or a history of psychiatric illness including anorexia nervosa and depression. Glaucoma History of drug/alcohol abuse or dependence. Concomitant treatment with monoamine oxidase (MAO) inhibitors or within 14 days following their administration. Co-administration of drug products for weight loss. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Razin capsules may be used for a period of up to 3 months of treatment. Razin capsules are indicated only as read_full_document