Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIANEPTINE SODIUM
SERVIER MALAYSIA SDN BHD
TIANEPTINE SODIUM
30Tablet Tablets
LES LABS SERVIER INDUSTRIE
_Consumer Medication Information Leaflet (RiMUP) _ 1 STABLON 12.5MG COATED TABLETS Sodium tianeptine 12.5mg WHAT IS IN THIS LEAFLET 1. What STABLON 12.5mg is and what it is used for 2. How Stablon 12.5mg works 3. Before you use STABLON 12.5mg 4. How to use STABLON 12.5mg 5. While you are using STABLON 12.5mg 6. Side effects of STABLON 12.5mg 7. Storage and Disposal of STABLON 12.5mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT STABLON 12.5MG IS AND WHAT IT IS USED FOR STABLON 12.5mg is an antidepressant. This medicine is recommended in : - Neurotic and reactive depression - Anxio-depressive states with psychosomatic manifestations, especially gastrointestinal - Anxio-depressive states in alcoholic during withdrawal stage. HOW STABLON 12.5MG WORKS The active ingredient of STABLON 12.5mg, tianeptine increases the activity of cells in the brain and increases the rate of serotonin (a type of brain chemical) reuptake by neurones in the brain. Serotonin is important for nerve cells to communicate, which controls many body activities, including regulating mood. BEFORE YOU USE STABLON 12.5MG - _When you must not use it _ DO NOT TAKE STABLON 12.5MG - if you are allergic (hypersensitive) to tianeptine or any of the other ingredients of STABLON 12.5mg, - in children under 15 years of age, - in combination with drugs for depression of the non-selective MAOI class (see section “Taking other medicines”). IF YOU ARE IN ANY DOUBT, YOU MUST CONSULT YOUR DOCTOR OR YOUR PHARMACIST FOR ADVICE. - _Before you start to use it _ WARNINGS AND PRECAUTIONS - Prolonged use at high doses may lead to dependency. - Do not exceed the recommended doses. - Do not discontinue the treatment suddenly, but reduce the dosage over a period of 7 to 14 days. - If you must undergo general anaesthesia, it is advisable to notify the anaesthetist and to discontinue the treatment 24 or 48 hours before the operation. - Notify your doctor in case of kidney or liver failures. - As with any psychotropic trea Đọc toàn bộ tài liệu
Final PI_Stablon_17.05.2022 _ _ _1 _ STABLON INN : TIANEPTINE 1. NAME OF THE MEDICINAL PRODUCT STABLON 12.5 MG, COATED TABLET. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tianeptine sodium salt .................................................................................................................. 12.5 mg For one coated tablet Excipients with known effect: sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - Neurotic and reactive depression - Anxio-depressive states with psychosomatic manifestations, especially gastrointestinal - Anxio-depressive states in alcoholic during withdrawal stage. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended dosage is one tablet containing 12.5 mg, three times a day (morning, midday and evening) at the beginning of the main meals. SPECIAL POPULATIONS _Elderly subjects _ The efficacy and safety of tianeptine have been established in elderly depressed patients (≥ 65 years) (see section 5.1). No dose adjustment is required in relation to age In frail elderly patients (< 55 kg), the dosage should be restricted to 2 tablets per day (see section 5.2). _Renal failure _ In patients with severe renal failure (ClCr < 19 ml/min), the posology should be restricted to 2 tablets per day (see section 5.2). _Hepatic impairment _ In patients with severe cirrhosis (Class C, Child Pugh Score), the posology should be restricted to 2 tablets per day (see section 5.2). In chronic alcoholic patients, irrespective of whether they have mild or moderate cirrhosis or no cirrhosis, the posology does not need to be adjusted (see section 5.2). _Paediatric population _ The safety and efficacy of tianeptine in children and adolescents under 18 years of age have not been determined. There is no data available (see section 4.4). Tianeptine is contraindicated in children and adolescents under 15 years old (see section 4.3). _Discontinuation of treatment _ Final PI_Stablon_17.05.2022 _ _ _2 Đọc toàn bộ tài liệu