Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
TIANEPTINE SODIUM
SERVIER (S) PTE LTD
N06AX14
12.5 mg
TABLET, SUGAR COATED
TIANEPTINE SODIUM 12.5 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE
ACTIVE
1999-10-07
SPC_20.08.2012 1 PACKAGE INSERT 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. Excipient: sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS This drug is recommended in depressive states of mild, moderate or severe intensity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one 12.5 mg tablet three times a day (morning, midday and evening) at the beginning of the main meals. In chronic alcoholics, whether cirrhotic or not, no alteration of the dosage is necessary. In subjects aged over 70 years, and in subjects with renal insufficiency, the dosage should be restricted to 2 tablets per day. 4.3 CONTRAINDICATIONS Hypersensitivity to tianeptine or to any of the excipients Children under 15 years old. Association with MAOIs. A wash-out period of two weeks is required between treatment with MAOIs and treatment with tianeptine. A wash-out period of only 24 hours is required when replacing tianeptine with an MAOI. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING Depression is associated with an increased risk of suicidal thoughts, self-harming and suicidality (suicidal behaviour). This risk persists until a significant remission has been obtained. Clinical improvement may not be obtained until after several weeks of treatment, and so patients must be closely monitored until this improvement has been achieved. Clinical experience shows that the risk of suicide can increase during the very early stages of recovery. Patients with a history of Prečítajte si celý dokument
_ _ 1 PACKAGE INSERT 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 a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS This drug is recommended in depressive states of mild, moderate or severe intensity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one 12.5 mg tablet three times a day (morning, midday and evening) at the beginning of the main meals. In chronic alcoholics, whether cirrhotic or not, no alteration of the dosage is necessary. In subjects aged over 70 years, and in subjects with renal insufficiency, the dosage should be restricted to 2 tablets per day. _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 drug substance or to any of the excipients mentioned in section 6.1. ▪ Children and adolescents under 15 years old. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING Depression is associated with an increased risk of suicidal thoughts, self-harming and suicide (suicidal behaviour). This risk persists until a significant remission has been obtained. Clinical improvement may not be obtained until after several weeks of treatment, therefore, patients must be closely monitored until this improvement has been achieved. Clinical experience shows that the risk of suicide can increase during the very early stages of recovery. Patients with a history of suicidal type behaviour or those expressing significant suicidal thoughts before starting the treatment fa Prečítajte si celý dokument