Sibutramine - Downtrat EN.pdf

Name of the product: DOWNTRAT 10

Active ingredient: Sibutramine 10 mg (as sibutramine hydrochloride monohydrate)

Dosage form: hard capsules

Name of the product: DOWNTRAT 15

Active ingredient: Sibutramine 15 mg (as sibutramine hydrochloride monohydrate)

Dosage form: hard capsules

Dispensing requirements: Rx only

Argentine Industry

Composition:

DOWNTRAT 10:

Each tablet contains sibutramine 10 mg (as sibutramine hydrochloride monohydrate), lactose, microcrystalline cellulose, colloidal silicium dioxide and magnesium estearate.

DOWNTRAT 15:

Each tablet contains sibutramine 15 mg (as sibutramine hydrochloride monohydrate), lactose, microcrystalline cellulose, colloidal silicium dioxide and magnesium estearate.

Indications:

DOWNTRAT is indicated for the treatment of the obesity as complement of the hypocaloric diet to loose weight and to maintain the weight loss.

Therapeutic action:

Complementary treatment for the obesity.

Storage:

Keep at room temperature, below 15º C, in the marketed packing.

Marketed presentations:

DOWNTRAT 10:

Packs containing 20 and 30 capsules, for use in hospitals.

DOWNTRAT 15:

Packs containing 20 and 30 capsules, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 52495

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist