PACKAGE INSERT TRADE NAME OF DRUG: Carsil INN: Silymarin DRUG FORM: Carsil coated tablets of 35.0 mg COMPOSITION: One coated tablet contains (mg):
Active substance: Silymarin (as 100%) 35.0 mg
Additives: Lactose, Wheat starch, Sorbite, Glucose, Microcrystaline cellulose, Talk, Magnesium Stearate, Polyvinylpyrolidone, Sodium bicarbonate.
PHARMACO-THERAPEUTIC GROUP: Lipotropic agent with hepatoprotective action. INDICATIONS: Chronic inflammation of liver, hepatic dystrophy; cirrhosis of liver; fatty degeneration due to hepatitis, damage of the liver with functional disorders caused by intoxication; as a prophylactic agent in cases with enhanced intake of substances and drugs overloading the hepatic function. CONTRAINDICATIONS: Hypersensitivity to Silymarin WARNINGS: The drug can be administered only under physician’s supervision during pregnancy and breast feeding period, and only if the drug treatment benefit outweighs the risk of its administration. No data is available about disorders in driving ability and machine operation in Carsil treated patients. ADMINISTRATION AND DOSAGE: It is perorally administered: adults 1 – 2 coated tablets, 3 times daily. In cases of highly disordered hepatic function, the daily dose may be doubled. The treatment courses last at least 3 months. Carsil can be prescribed prophylactically – 70 – 100 mg daily. The daily dose for children is 5 mg/kg body weight, devided into 2 – 3 intakes. UNDESIRED SIDE EFFECTS: Undesired adverse effects necessitating the discontinuation of the treatment have not been observed so far – neither during a short-term high dosage, nor during long-term treatment. Light laxative and diuretic effect has been observed in some patients. Some disorders of the vestibular functions and disorders in the digestion can occur or pre-existing ones can be aggravated during long-term treatment with Carsil, which usually abate after discontinuation. SUPPLIED: Packages with 80 coated tablets of 35 mg. STORAGE: In original packages. In dry and light-protected place, at a temperature of 15 – 20ºC. EXPIRY TERM: 2 years Sopharma AD 16 Iliensko Chosee St, Sofia, Bulgaria. |