Index of drugs

hypercholesterolemia. Treatment of primary hypercholesterolemia or mixed dyslipidemia, as a dietary supplement, when the response to diet or other nonpharmacological treatment (eg physical exercise, weight loss) is insufficient. Treatment of familial homozygous hypercholesterolemia, as a supplement to diet and other lipid-lowering therapy (eg LDL apheresis) or if such treatment is inappropriate or unavailable.Prevention of events from the cardiovascular system. Reduce morbidity and mortality from cardiovascular disease in patients with overt atherosclerosis or diabetes, with normal or elevated cholesterol, as adjunctive therapy to correct other risk factors or to supplement other treatments to prevent heart disease.

1 tabl contains 20 mg or 40 mg Simvastatin (and 140 mg or 280 mg lactose, respectively).

Hypersensitivity to the active substance or to any of the excipients. Active liver disease or persistent, unexplained elevation of blood transaminases. Concomitant use of strong CYP3A4 inhibitors such as Itraconazole, ketoconazole, posaconazole, HIV protease inhibitors (eg nelfinavir), Erythromycin, Clarithromycin, telithromycin, nefazodone. Pregnancy. Breastfeeding period.

The drug is contraindicated during pregnancy (mother's treatment with simvastatin may reduce the fetus concentration of mevalonate, which is a precursor to cholesterol biosynthesis). Do not use in women planning pregnancy or those who are suspected of being pregnant. It is not known whether simvastatin or its metabolites are excreted in human milk - do not use during breast-feeding due to the possibility of serious side effects in the infant.

Rare: anemia, headache, paresthesia, dizziness, peripheral neuropathy, constipation, abdominal pain, flatulence, indigestion, diarrhea, nausea, vomiting, pancreatitis, hepatitis, jaundice, rash, pruritus, alopecia, myopathy (often after 80 mg), including muscle inflammation; rhabdomyolysis (with or without acute renal failure), muscle pain, muscle spasms, weakness, symptoms of hypersensitivity syndrome (angioneurotic edema, lupus-like syndrome, rheumatoid type muscle pain, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, accelerated OB, arthritis , arthralgia, urticaria, hypersensitivity to light, fever, redness, difficulty in breathing, malaise), increase in blood transaminases (ALT, AST, GGT), increase in ALP, increase in CK in the blood. Very rare: insomnia, impaired memory, interstitial lung disease, liver failure. Frequency unknown: depression, erectile dysfunction. Side effects characteristic of statins: sleep disorders (including nightmares), memory loss, sexual dysfunction, diabetes (frequency depends on the presence or absence of risk factors, i.e. fasting blood Glucose ≥ 5.6 mmol / l, BMI> 30 kg / m2, increased triglycerides, history of hypertension). The long-term effect of simvastatin is not known for the physical and intellectual development and sexual maturation of children and adolescents.

Orally. The dose range is 5-80 mg / day. If necessary, the dose should be adjusted at intervals of at least 4 weeks to a maximum of 80 mg / day. A dose of 80 mg per day is only recommended for patients with severe hypercholesterolaemia and a high risk of cardiovascular complications who have not achieved the goals of treatment with a lower dose. The patient should use a standard low-cholesterol diet, which should be continued during treatment.hypercholesterolemia10-20 mg once a day; if it is necessary to reduce the LDL-cholesterol> 45%, the initial dose may be 20-40 mg once a day.Homozygous familial hypercholesterolaemia: 40 mg once daily (or 80 mg / day in 3 doses: in the morning and at noon after 20 mg, and in the evening 40 mg).Prevention of cardiovascular diseases20-40 mg once a day.Combination treatment with other medicines: simvastatin should be taken not less than 2 hours before or not less than 4 hours after administration of bile acid sequestrants. In the case of simultaneous treatment with cyclosporin, danazol, gemfibrozil and other fibrates (except fenofibrate) the simvastatin dose can not be> 10 mg / day. Patients who take either Amiodarone or Verapamil concomitantly with simvastatin must not receive simvastatin> 20 mg / day. In patients taking diltiazem or Amlodipine, the dose of simvastatin should not be> 40 mg / day.Special groups of patients. In patients with severe renal impairment (CCr <30 ml / min), simvastatin> 10 mg / day should be carefully considered and, if necessary, very cautiously start treatment. No dosage adjustment is necessary in patients with mild or moderate renal impairment or in elderly patients.Children and adolescents10-17 years (boys ≥12 on the Tanner scale and girls at least one year from the first menstruation) with heterozygous familial hypercholesterolaemia: the recommended starting dose is 10 mg per day. The recommended dose range is 10-40 mg / day. The largest recommended dose is 40 mg per day. Doses should be adjusted individually according to the recommended goal of therapy according to the recommendations for treatment of children and adolescents. The dose should be adjusted at intervals of at least 4 weeks. The appropriate diet should be used. There is limited experience in the use of simvastatin in pre-pubertal children.Way of giving. The drug should be taken once a day, in the evening.