Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, SUGAR COATED
**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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**4.1 Therapeutic indications** This drug is recommended in depressive states of mild, moderate or severe intensity.
**4.3 Contraindications** - Hypersensitivity to drug substance or to any of the excipients mentioned in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Children and adolescents under 15 years old.
N06AX14
tianeptine
Manufacturer Information
SERVIER (S) PTE LTD
LES LABORATOIRES SERVIER INDUSTRIE
Active Ingredients
Documents
Package Inserts
Stablon Tablet PI.pdf
Approved: November 14, 2019