Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
TIANEPTINE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
N06AX14
TIANEPTINE 12.5 mg
COATED TABLET
TIANEPTINE 12.5 mg
POM
PSYCHOANALEPTICS
Authorised
2005-08-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER STABLON ® 12.5 MG COATED TABLETS Tianeptine, sodium salt READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Stablon is and what it is used for 2. What you need to know before you take Stablon 3. How to take Stablon 4. Possible side effects 5. How to store Stablon 6. Contents of the pack and other information 1. WHAT STABLON IS AND WHAT IT IS USED FOR Stablon is an antidepressant. This medicine is recommended in major depressive disorders (i.e. typical). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STABLON DO NOT TAKE STABLON - if you are allergic to tianeptine or any of the other ingredients of this medicine (listed in Section 6), - in children under 15 years of age, - if you are pregnant or breastfeeding, If you have any doubt, you must consult your doctor or pharmacist for advice. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Stablon. - Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: - If you have previously had thoughts about killing or harming yourself. - If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an a Leggi il documento completo
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Stablon 12.5 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tianeptine (INN), sodium salt ............................................................................................. 12.5 mg Excipient(s) with known effect: 24 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, oval coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Major depressive episodes (i.e. typical). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 1 tablet (12.5 mg) three times a day (morning, midday and evening) before the main meals of the days. Method of administration Oral use. Special populations _Elderly _ 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/day (see section 5.2). _ _ _Renal impairment _ In patients with severe renal impairment (CLCR<19ml/min), the dosage should be 2 tablets/day (see section 5.2). _Hepatic impairment _ In patients with severe cirrhosis (Class C, Child Pugh’s Scale), the dosage should be 2 tablets/day (see section 5.2). In chronic alcoholics, whether mildly or moderately cirrhotic or not cirrhotic at all, no dosage adaptation is needed (see section 5.2). _Paediatric population _ The safety and efficacy of tianeptine in children and adolescents below 18 years have not been established. No data are available (see section 4.4). Page 2 of 10 _Discontinuation of treatment _ Abrupt discontinuation of the treatment should be avoided. The dosage should be gradually reduced over a period of 7 to 14 days in order to reduce the risk of withdrawal reactions (see sections 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under 15 years old. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - Leggi il documento completo