STABLON Coated tablet Ref.[7676] Active ingredients: Tianeptine

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Product name and form

Stablon 12.5 mg coated tablets.

Pharmaceutical Form

White, oval coated tablets.

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.

Active Ingredient Description
Tianeptine

Tianeptine is an antidepressant. In man, tianeptine is characterised by marked action on somatic complaints, especially gastrointestinal complaints related to anxiety and mood disturbances. Moreover, tianeptine has no effect on sleep and alertness nor on the cholinergic system (no anticholinergic symptoms).

List of Excipients

Tablet:

Maize starch
Mannitol
Magnesium stearate
Talc

Coating:

Sodium bicarbonate
Sodium carboxymethylcellulose
White beeswax
Titanium dioxide (E171)
Ethylcellulose
Glycerol 80
Polysorbate 80
Povidone
Sucrose
Anhydrous colloidal silica
Talc

Pack sizes and marketing

30 tablets in heat-sealed blister packs (PVC/aluminium).

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Marketing authorization dates and numbers

Date of first authorisation: 19 August 2005
Date of latest renewal: 06 September 2010

Drugs

Drug Countries
STABLON Austria, Brazil, France, Hong Kong, Malta, Singapore, Tunisia, Turkey

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.