Description
Summary of Product CharacteristicsIndications:
Major
depressive episodes (mild, moderate, or severe).
Properties:
In
man, tianeptine is characterized by an action on anxious symptomatology
associated with depression.
Dosage and administration:
The
recommended dosage is 3 tablets daily, 1 in the morning, 1
at midday, and 1 in the evening before the main meals of the
day. In chronic alcoholics, whether cirrhotic or not, no alteration
of dosage is necessary. In subjects over 70 years of age,
and in subjects with renal insufficiency, the dosage should
be restricted to 2 tablets per day.
Contraindications:
Children
under 15 years of age; combination with MAOIs; pregnancy;
lactation.
Precautions:
Given
the inherent suicide risk in depressed patients, patients
should be carefully monitored, especially at the beginning
of treatment; precautions in case of anesthesia; the attention
of drivers and machine-operators should be drawn to the risk
of drowsiness; as with all psychotropic agents, if the treatment
is to be interrupted, the dosage should be gradually reduced.
Drug interactions:
With
nonselective MAOIs.
Side effects:
Rare
and generally not severe: epigastric pain, abdominal pain,
dry mouth, anorexia, nausea, vomiting, constipation, flatulence;
insomnia, drowsiness, nightmares, asthenia; tachycardia, extrasystoles,
precordial pain; vertigo, headache, lipothymia, tremor, hot
flushes; respiratory discomfort, lump in the throat; myalgia,
back pain.
How supplied:
Coated
tablets of 12.5 mg tianeptine sodium salt per tablet.
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