Expiration date: 03/2025
The composition and form of issue:
Tablets, film-coated. 1 tablet contains active substance:
simvastatin 10, 20 or 40 mg
excipients: MKC — 70/140 mg of lactose monohydrate (milk sugar) — 21/42 mg pregelatinization starch (starch 1500) from 33.73/67,46 mg silica colloidal anhydrous (Aerosil) is 0.75/1.5 mg ascorbic acid and 2.5/5 mg butylhydroxyanisole — 0,02/0,04 mg stearic acid is 1.25/2.5 mg of magnesium stearate and 0.75/1.5 mg polyvinyl alcohol of 2.33/4.66 mg macrogol (polyethylene glycol) — 1,18/2,36 mg dye iron oxide black — 0,02/0,04 mg talc is 0.86/1,72 mg dye iron oxide yellow — 0,28/0,56 mg dye iron oxide red — 0,19/0,38 mg titanium dioxide — 0,97/1,94 mg
10 PCs in blister from PVC film and aluminum foil printed patent in the paper cartons 1, 2, 3, 4 or 5 packs.
Method of application and dose:
Inside, 1 time a day, in the evening, squeezed enough water. The drug should not be linked with food intake.
Before starting treatment with Simvastatin, patients should apply a standard gipoholesterinovu diet that must be adhered to throughout the course of treatment.
The recommended dose of Simvastatin for treatment of hypercholesterolemia ranges from 10 to 80 mg 1 time per day in the evening. The recommended initial dose for patients with hypercholesterolemia is 10 mg. Maximum daily dose of 80 mg.
Changes (selection) the dose should be carried out at intervals of 4 weeks. In most patients the optimal effect is achieved when taking the drug in doses up to 20 mg/day.
In patients with homozygous hereditary hypercholesterolemia the recommended daily dose of Simvastatin is 40 mg 1 time per day or evening 80 mg 3 reception (20 mg morning, 20 mg day and 40 mg in the evening).
In the treatment of patients with CHD or high risk for coronary heart disease effective dose amount of Simvastatin 20-40 mg/day. Therefore, the recommended initial dose in such patients — 20 mg/day. Changes (selection) the dose should be carried out at intervals of 4 weeks, the dose can be increased to 40 mg/day. If LDL <75 mg/DL (1,94 mmol/l), total cholesterol <140 mg/DL (3.6 mmol/l), the dose should be reduced.
Elderly patients and patients with mild-to-moderately severe renal failure changes dosage not required.
In patients with chronic renal failure (Cl creatinine <30 ml/min) or receiving ciclosporin, danazol, gemfibrozil or other fibrates (except phenofibrate), nicotinic acid lepidotrigla doses (&ge1 g/day) in combination with Simvastatin, the maximum recommended dose of Simvastatin should not exceed 10 mg/day.
For patients taking amiodarone or verapamil simultaneously with Simvastatin, the daily dose should not exceed 20 mg.
