البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
POTASSIUM CLORAZEPATE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
N05BA05
CAPSULES
POTASSIUM CLORAZEPATE 15 MG
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
POTASSIUM CLORAZEPATE
POTASSIUM CLORAZEPATE
For the management and relief of anxiety, symptomatic relief of acute alcohol withdrawal, adjunctive therapy in the management of partial seizures.
2022-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor's prescription only TRANXAL 5 MG CAPSULES TRANXAL 15 MG CAPSULES THE ACTIVE INGREDIENT AND ITS QUANTITY: Tranxal 5 mg: Each capsule contains Potassium Clorazepate 5 mg Tranxal 15 mg: Each capsule contains Potassium Clorazepate 15 mg Inactive ingredients and allergens in the preparation – see 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 your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. INTRODUCTION The introduction is intended for users taking this medicine for the indication of anxiety and tension only. This medicine belongs to the benzodiazepine group, which has special characteristics that require extra care during use. · It is highly important to be under close medical supervision when taking this medicine. · When taking this medicine, be sure to refer to your doctor after 2-4 weeks, as the treatment is intended for short time periods only. · Prolonged use of this medicine may cause the effect of the medicine to decrease. · Prolonged use may cause severe dependency, which will make it difficult for the patient to stop taking the medicine. · Uncontrolled discontinuation of the treatment may be accompanied by withdrawal effects, such as: stress, nervousness, confusion, tremor, insomnia, abdominal pain, vomiting, nausea, sweating, spasms, cramps and muscle pain. · Prolonged use of this medicine may sometimes cause changes in behavioral patterns and obsessive thoughts. · Care should be taken when walking, especially in the elderly, since the medicine impairs alertness and sometimes the coordination of body movements, which may lead to tripping or falling down. Taking this medici اقرأ الوثيقة كاملة
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT TRANXAL 5 MG, HARD CAPSULES TRANXAL 15 MG, HARD CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tranxal 5 mg- Clorazepate dipotassium 5mg Tranxal 15 mg- Clorazepate dipotassium 15mg 3. PHARMACEUTICAL FORM Capsules WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death _[_see _chapter _DRUG INTERACTIONS_]_. • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the management and relief of anxiety, symptomatic relief of acute alcohol withdrawal, adjunctive therapy in the management of partial seizures. 4.2 Posology and route of administration Duration: Treatment should be as of a short duration as possible and reassessed on a regular basis, particularly if the patient has no symptoms. The overall duration of treatment should not exceed 8 to 12 weeks in most of patients, including the period of dosage tapering (see sections WARNINGS and PRECAUTIONS). In some cases, it may be necessary to prolong treatment beyond the recommended period. Prolonged treatment requires careful and repeated assessments of the patient's status. 2 Prevention and treatment of delirium tremens and other symptoms of alcohol withdrawal: short-term treatment of about 8 to 10 days. Pediatric population Tranxal is not indicated for the management of partial seizures in pediatric patients under 9 years old. Tranxal is not indicated for the management and relief of anxiety and symptomatic relief of acute alcohol withdrawal in pediatric patients under 6 years old. Dose: In all cases, treatment must be initiated at the lowest effective dose, and the maximum dose of 90 mg اقرأ الوثيقة كاملة