Expiration date: 05/2026

DOSAGE FORMS

tablets film-coated 10, 20 or 40mg

MANUFACTURERS

Alkaloid of AO (Macedonia)

Alkaloid AO

Packed kanonfarma Prodakshn (Macedonia)

GROUP

Lipid-lowering means inhibitors of HMG-COA reductase

COMPOSITION

The active substance is Simvastatin.

INTERNATIONAL NONPROPRIETARY NAME

Simvastatin

SYNONYMS

Actalipid, Aterostat, Vasilip, Vero Simvastatin, Savatin, Zocor, Zocor Forte, Trstat, Levemir, Ofankor, Simvahexal, Simvatin, Simvacol, Simvalimit, Simvastatin, Simvastatin-Sz Simvastatin-Verein, Simvastol, Simvor, Simgal, Simla, Simcard

PHARMACOLOGICAL ACTION

Hypocholesteremic. Reduces both elevated and normal cholesterol levels, the concentration of LDL (low density lipoprotein) and VLDL (lipoprotein of very low density). Increases LPVP content and reduces the concentration of triglycerides. In the absence of inheritance of LDL receptors (homozygous familial hypercholesterolemia) simvastatin ineffective. A reliable clinical result after 2 weeks after the start of treatment, the maximum - 4-6 weeks. Long-term use increases the survival of patients with hypercholesterolemia and ischemic heart disease, reduces the progression of atherosclerotic lesions of the coronary arteries. Active with poor diet and etc. non-pharmacological treatments. After oral administration the concentration of simvastatin and its metabolites (formed mainly in the liver) reaches a maximum after 4 hours and is reduced by 90% after 12 h Simvastatin and its biotransformation products in plasma, 95% protein bound. Excreted as metabolites in the bile and urine.

INDICATIONS FOR USE

Hypercholesterolemia in the absence of the effect of diet, combined hypercholesterolemia and triglyceridemia, ischemic heart disease, prevention of myocardial infarction and stroke, atherosclerosis.

CONTRAINDICATIONS

Hypersensitivity, acute liver dysfunction, severe renal failure, pregnancy, breast-feeding, child age.

SIDE EFFECTS

Diarrhoeal phenomenon, diarrhoea, flatulence, nausea, exacerbation of pancreatitis and hepatitis, raising transaminaz, disorders of the Central nervous system (headache, paresthesia, cramps), myalgia, asthenia, myopathy, rhabdomyolysis, photosensitization, allergic reactions (vasculitis, urticaria, arthralgia, thrombocytopenia, eosinophilia, angioneurotic edema, symptoms similar to lupus erythematosus).

INTERACTION

Immunodepressus therapy, high doses of nicotinic acid, antifungals - derivatives Azola (ketoconazole, Itraconazole) increase the risk of myopathy and rhabdomyolysis. Do indirect effects anticoagulants, gepatotoksicnosti alcohol and drugs, are negatively acting on the liver.

OVERDOSE

Treatment: induction vomiting, the appointment of activated carbon, monitoring of liver, kidney, respiratory system, cardiovascular system and the content of creatine kinase in serum.

SPECIAL INSTRUCTIONS

Before and during treatment to monitor liver function and caution is prescribed for violations. During the course of therapy is necessary to control cholesterol levels. Be wary designate patients who misuse alcohol and /or having a history of liver disease after organ transplants, for conditions that can be accompanied by the development of severe renal failure. At occurrence of unexplained muscle pain, tenderness and weakness of the muscles need to consult a doctor. Significant increase in the level of creatine kinase or suspected myopathy require discontinuation of the drug.

STORAGE CONDITIONS

List B. Store in a dry place at room temperature.