Simvastatin - Dosavastatin EN.pdf

Name of the product: DOSAVASTATIN 5 (*)

Active ingredient: Simvastatin 5 mg

Dosage form: film-coated tablets

Name of the product: DOSAVASTATIN 10

Active ingredient: Simvastatin 10 mg

Dosage form: film-coated tablets

Name of the product: DOSAVASTATIN 20

Active ingredient: Simvastatin 20 mg

Dosage form: film-coated tablets

Name of the product: DOSAVASTATIN 40 (*)

Active ingredient: Simvastatin 40 mg

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

DOSAVASTATIN 5:

Each film-coated tablet contains simvastatin 5 mg, lactose monohydrate, BHA, ascorbic acid, citric acid, microcrystalline cellulose pH 101, microcrystalline cellulose pH 102, sodium croscarmellose, colloidal silicium acid, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, and titanium dioxide.

DOSAVASTATIN 10:

Each film-coated tablet contains simvastatin 10 mg, lactose monohydrate, BHA, ascorbic acid, citric acid, microcrystalline cellulose pH 101, microcrystalline cellulose pH 102, sodium croscarmellose, colloidal silicium acid, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide and indigotine aluminium lake.

DOSAVASTATIN 20:

Each film-coated tablet contains simvastatin 20 mg, lactose monohydrate, BHA, ascorbic acid, citric acid, microcrystalline cellulose pH 101, microcrystalline cellulose pH 102, sodium croscarmellose, colloidal silicium acid, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, and titanium dioxide.

DOSAVASTATIN 40:

Each film-coated tablet contains simvastatin 40 mg, lactose monohydrate, BHA, ascorbic acid, citric acid, microcrystalline cellulose pH 101, microcrystalline cellulose pH 102, sodium croscarmellose, colloidal silicium acid, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide and yellow aluminium lake.

Indications:

DOSAVASTATIN is indicated to reduce the risk of coronary death and non-fatal myocardial infarction. DOSAVASTATIN reduces the risk of undergoing miocardial revascularisation procedures (coronary artery bypass and percutaneous transluminal coronary angioplasty); slows down the progression of coronary arteriosclerosis including the development of new lesions and total oclusions. DOSAVASTATIN is indicated as an adjunct diet to reduce elevated levels of total cholesterol, LDL cholesterol, apoliprotein-B and triglicerids in patients with primary hypercholesterolemia, familiar heterozigous hypercholesterolemia or combined (mixed) hyperlipidemia when the response to the diet or to other non pharmacological mesures has been inadequate.

Therapeutic action:

Hypercholesterolemiant.

Storage:

Keep between 15º and 20º C in the marketed packing.

Marketed presentations:

Packs containing 30 and 60 film-coated tablets.

Packs containing 500 film-coated tablets, for use in hospital.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 51679

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist