Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BROTIZOLAM
RAFA LABORATORIES LTD
N05CD09
TABLETS
BROTIZOLAM 0.25 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
BROTIZOLAM
BROTIZOLAM
Treatment of Insomnia.
2010-10-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only BONDORMIN TABLETS ACTIVE INGREDIENT: Each tablet contains 0.25 mg brotizolam. For a list of the other ingredients, please see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or 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 to yours. INTRODUCTION TO THE PATIENT LEAFLET FOR BENZODIAZEPINES This medicine belongs to the group of benzodiazepines, which has special properties requiring the utmost caution while using it. Close medical follow-up is very important while taking this medicine. When taking this medicine, make sure to refer to your doctor after two weeks, since treatment is intended for short periods of time only. Prolonged use of this medicine may cause a reduction in its effect. Prolonged use may cause a severe effect of dependence, making it difficult for the patient to discontinue taking the medicine and therefore, discontinuation of the medicine should be done gradually, according to the doctor's instructions. Uncontrolled discontinuation of treatment is accompanied by withdrawal symptoms, such as: tension, nervousness, confusion, tremor, insomnia, abdominal pains, vomiting, nausea, sweating, spasms, cramps and muscle pain. Sometimes prolonged use of the medicine may cause changes in behavioral patterns and nagging thoughts. Especially in the elderly, caution is recommended when walking, since the medicine impairs alertness and sometimes coordination of body movements, thus raising concern about stumbles or falls. Taking this medicine along with medicines from the opioid group, other medicines which depres সম্পূর্ণ নথি পড়ুন
Page 1 of 10 Bondormin-DL-April 2017-01 Doctor leaflet 1. NAME OF THE MEDICINAL PRODUCT BONDORMIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Bondormin tablet contains 0.25 mg brotizolam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. The tablet can be divided into 2 equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Insomnia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Unless otherwise prescribed, the usual dose is ½ - 1 tablet a day (equivalent to 0.125 - 0.25 mg brotizolam). Treatment should be started with ½ a tablet a day (equivalent to 0.125 mg brotizolam). Depending on individual response, ½ a tablet a day (equivalent to 0.125 mg brotizolam) may be sufficient. The WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. 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. Page 2 of 10 maximum dose of 1 tablet a day (equivalent to 0.25 mg brotizolam) should not be exceeded because of the increased risk of adverse CNS effects. In isolated cases (e.g. pre-operative sleep disturbances) the dose may be increased to 2 tablets. Special populations: A reduction in dosage to ½ a tablet a day should be considered in the following populations (see section 4.4): - patients with impaired liver function (see section 4.3 and section 5.2) - elderly and debilitated patients (see section 5.2) - patients with chronic respiratory insufficiency with hypercapnia due to the risk of respiratory depression, especially at night (see section 4.3) The tablets can be divided into equal halves for this purpose. No dosage adjustment is normally necessary in patients with impaired renal function (see 5.2). _Paediatric population _ Bondor সম্পূর্ণ নথি পড়ুন