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

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).

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).

Symptoms

Experience with tianeptine in overdose (the maximum amount was 2250 mg in a single intake) has indicated signs and symptoms including: confusional state, convulsion, somnolence, dry mouth and respiratory distress mainly when tianeptine was associated with alcohol.

Management

In all cases, stop treatment and monitor the patient closely.

• Gastric lavage can be performed if the drug was ingested less than 2 hours prior to hospitalisation. After this interval activated charcoal can be administered.
• Cardio-respiratory, metabolic and renal monitoring.
• Symptomatic treatment of any clinical manifestations, especially assisted ventilation and correction of metabolic and renal disorders.

No specific antidote is known for tianeptine.

3 years.

Store below 30°C.

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

No special requirements.