Stablon 12.5 mg, 30 tablets

Trade Name:

Stablon

Tianeptine 12.5 mg 

30 sugar coated tablets

Composition:

Tianeptine (sodium salt) 12.5 mg 

Inactive ingredients: 

D-mannitol, maize starch, talc, magnesium stearate, ethylcellulose, glycerol oleate, Sepifilm SE 700 White (povidone, sodium carmellose, anhydrous colloidal silica, talc, sucrose, polysorbate 80, titanium dioxide, sodium hydrogen carbonate), white beeswax.

Properties:

Tianeptine is an antidepressant.

In animals, tianeptine has the following properties: tianeptine increases the spontaneous activity of pyramidal cells in the hippocampus and accelerates their recovery after functional inhibition; tianeptine increases the rate of serotonin re-uptake by neurons in the cortex and hippocampus.

In man, tianeptine is characterized by: marked action on somatic complaints, especially gastrointestinal complaints related to anxiety and mood disturbances.

Moreover, tianeptine has no effect on: sleep and alertness; the cholinergic system (no anticholinergic symptoms).

Indications:

Major depressive episodes 

Dosage and 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.

Side effects:

Side effects reported with tianeptine in clinical trials are of moderate intensity. They consist mainly of nausea, constipation, abdominal pain, somnolence, headache, dry mouth and dizziness.

Contraindications:

-Children and adolescents under 15 years of age;

-Hypersensitivity to tianeptine or any of the tablet’s excipients.

Warnings and precautions:

• Pregnancy: It is preferable to maintain a good psychological balance throughout pregnancy. If medical treatment is necessary to ensure this balance, treatment should be initiated or continued at an effective dose throughout pregnancy and if possible as monotherapy.

Animal data is reassuring but clinical data is still insufficient. In consideration of this data, it is preferable not to use tianeptine during pregnancy whatever the term. If initiation or continuation of treatment by tianeptine proves to be vital during pregnancy, the pharmacological profile of the molecule should be taken into account when monitoring the newborn baby.

• Breast-feeding: Tricyclic antidepressants are excreted into breast milk, and thus breast-feeding is not recommended during treatment.
• Fertility: A study demonstrated in rats a decrease in reproductive performance in females (increase in pre-implantation losses) at a maternotoxic dose. The clinical impact is unknown.
• Drug Interactions:

Combinations that are inadvisable: Irreversible MAOIs (iproniazid): because of the risk of cardiovascular collapse or paroxysmal hypertension, hyperthermia, convulsions, death.

• If general anesthesia is necessary, the anesthetist should be informed of the treatment, and the drug discontinued 24 or 48 hours prior to surgery.

In an emergency, surgery may be performed without an intervening wash-out period; perioperative monitoring should be performed.

• As with any psychotropic drug, this medicinal product should not be taken with alcoholic beverages or medicines containing alcohol.
• Do not exceed the recommended doses.
• This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
• Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm 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, 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.
• Effects on ability to drive and use machines: 

Some patients may experience diminished alertness. The attention of drivers and machine-operators in particular should thus be drawn to the risk of somnolence with this product.

• Use in Children: STABLON is contraindicated in children and adolescents under 15 years of age.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds 3 blisters each of 10 sugar coated tablets, paper instructions