Name of the product: VIGABATRIN DOSA (*)

Active ingredient: Vigabatrin 150 mg

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

Each film-coated tablet contains vigabatrin 500 mg, sodium starch glycolate, microcrystalline cellulose, titanium dioxide, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 8000, and povidone.

Indications:

VIGABATRIN DOSA in combination with other anti-epileptic drugs is indicated for the treatment of resistant partial epilepsy with or without secondary generalisation that cannot be satisfactorily controlled by any other anti-epileptic drug, or when other drug combinations have not been tolerated; also, as single therapy for the treatment of spasms in infant patients (West syndrome).

Therapeutic action:

Anti-epileptic.

Storage:

Keep at room temperature between 15º and 25º C in the marketed packing.

Marketed presentations:

Packs containing 10, 30, 60 and 120 film-coated tablets.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 53132

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist