TRIVASTAL RETARD 50 TABLET 50 MG [SIN09947P]

Product Info

TRIVASTAL RETARD 50 TABLET 50 MG

[SIN09947P]

4.1 Therapeutic indications

The medicine is a dopaminergic agonist.

It is recommended in treatment of Parkinson’s disease.

4.2 Posology and method of administration

Oral route.
The tablets are to be swallowed with a half-glass of water, without chewing, at the end of meals.

Treatment of Parkinson's disease:

• as monotherapy : 150 mg to 250 mg, i.e. 3 to 5 tablets per day, to be divided into 3 to 5 administrations per day.

These doses must be attained gradually: increase by one tablet every three days.

Discontinuation of treatment

• Sudden discontinuation of dopamine agents may result in neuroleptic malignant syndrome. To avoid this risk the dose of piribedil must be reduced gradually until complete discontinuation of treatment.

Impulse control disorders

• To avoid the risk of impulse control disorders, prescription of the minimum effective dose is recommended. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Kidney or liver failure

• Piribedil has not been studied in these groups of patients. It is recommended to treat these patients with caution.

Paediatric population

• The safety and efficacy of piribedil in children under the age of 18 years have not been established. There is no available data. There is no justified use of piribedil in the paediatric population for this indication.

4.3 Contra-indications

This medicine is contra-indicated in the following situations:

• hypersensitivity to piribedil, or to any of the excipients,

• cardiovascular shock,

• acute phase of myocardial infarction,

• in association with antiemetic neuroleptics (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).