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active ingredient: simvastatin; 1 film-coated tablet contains 20 mg of simvastatin; excipients: lactose, corn starch, butylhydroxyanisole (E 320), citric acid, ascorbic acid, corn starch, microcrystalline cellulose, magnesium stearate film shell: hypromellose, talc, propylene glycol, titanium dioxide (E 171).
Hypercholesterolemia Treatment of primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet when response to diet and other non-pharmacological treatments (eg, exercise, weight loss) is inadequate. Treatment of homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid-lowering treatments (eg, low-density lipid apheresis), if such treatments are not acceptable.
Cardiovascular Prevention Reducing cardiovascular mortality and morbidity in patients with overt atherosclerotic cardiovascular disease or diabetes mellitus, with normal or elevated cholesterol levels, as adjunctive therapy to correct other risk factors and to other cardioprotective therapy (see section “Pharmacological properties”).
Dosage & Administration
The recommended dose range – from 10 to 80 mg / day when administered orally one evening dose. If necessary, the dose may be changed every 4 weeks of treatment up to a maximum dose of 80 mg / day when it is administered as one dose in the evening. The dose of 80 mg / day is recommended only in patients with severe hypercholesterolaemia and high risk for cardiovascular complications.
Prevention of cardiovascular complications. For the treatment of patients with coronary artery disease and high risk for cardiovascular events (regardless of the presence or absence of hyperlipidemia), the recommended dose of simvastatin 20-40 mg / day for a single application in the evening. Drug therapy should be started simultaneously with diet and exercise. Dose correction should be carried out if necessary as described above.
Hypercholesterolemia. Patients should adhere to a standard lipid-lowering diet, and during treatment with simvastatin as well. The usual starting dose – 10-20 mg / day, when used 1 time in the evening. Patients who require a large reduction in LDL-C (over 45%), it is necessary to start with the dose of 20-40 mg / day, 1 time in the evening. Dose correction is performed in the manner described above, if necessary.
Hypersensitivity to simvastatin or to any component of the drug; liver disease in active phase; a steady rise in transaminase levels in blood serum of unknown origin; During pregnancy and breastfeeding; the combined use of potent inhibitors of the activity of cytochrome P450 3A4 (CYP 3A4) (such as itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone).