TIACOB Tablet Ref.[8438] Active ingredients: Tiapride

Revision Year: 2006  Publisher: HEXAL AG, Industriestrasse 25, 83607, Holzkirchen, Germany

Therapeutic indications

For the treatment of neuroleptic-induced tardive dyskinesia, mainly oro-bucco-lingual type.

Posology and method of administration

Adults should take 100–200 mg tiapride three times daily, depending on the severity of the disease and the body weight of the individual. The proposed daily dose for the claimed indication is 300–600 mg tiapride.

The effect of treatment may not be apparent until after a period of 4-6 weeks of treatment.

Tiacob tablets should preferably be taken with a little liquid after meals.

Tiapride is not intended for treatment in children.

Dosage in renal impairment

Creatinine clearance:

50-80 ml/min = 75% of the normal daily dose

10-50 ml/min = 50% of the normal daily dose

less than 10 ml/min = 25% of the normal daily dose

Overdose

Experience with overdose of tiapride is limited. Drowsiness, sedation, coma, hypotension and extrapyramidal symptoms have been observed. In the case of an acute overdose, the possibility of multiple drug use should be considered.

After an oral overdose, therapy to reduce absorption can be administered (gastric lavage in the case of a potentially severe intoxication and, if shortly after ingestion, administration of activated charcoal in combination with a laxative).

Because tiapride is moderately dialysed, haemodialysis should not be administered to eliminate the active substance.

There is no specific antidote to tiapride. Appropriate supportive measures should be administered, and careful evaluation of the vital functions and cardiac monitoring should be performed until the patient has recovered. In the case of severe extrapyramidal symptoms, anticholinergics should be administered.

Shelf life

2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/Aluminium blister pack:

Pack of 10 tablets.
Pack of 20 tablets.
Pack of 50 tablets.
Pack of 60 tablets.
Pack of 100 tablets.
Hospital pack: 500 (10 × 50 tablets).

Not all pack sizes may be marketed.

Special precautions for disposal

No special requirements.

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