Description

Compound: Each tablet contains:

rosuvastatin 10 mg

Auxiliary components: Lactose monohydrate, microcrystalline cellulose, dicalcium phosphate anhydrous, croscarmellose sodium, magnesium stearate.

Properties: Rosuvastatin reduces elevated concentrations of LDL cholesterol (LDL-C), total cholesterol (TC), triglycerides (TG), increases the concentration of high-density lipoprotein cholesterol (HDL-C), and also reduces the concentration of apolipoprotein B (ApoB), VLDL-C , TG-VLDL and increases the concentration of apolipoprotein A-I (ApoA-I). As a result of the action of rosuvastatin, a decrease in the coefficient (index) of atherogenicity is observed, which characterizes the improvement in the lipid profile in patients with hypercholesterolemia.

Indications: Fredrickson’s primary hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-pharmacological treatments (eg, exercise, weight loss) are inadequate; – familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (for example, LDL apheresis), or in cases where such therapy is not effective enough; -hypertriglyceridemia (type IV according to the Fredrickson classification) as an addition to the diet; – to slow the progression of atherosclerosis as an addition to the diet in patients who are indicated for therapy to reduce the concentration of total cholesterol and LDL-C; Primary prevention of major cardiovascular complications.

Mode of application: Inside, do not chew or crush the tablet, swallow it whole with water. The drug can be administered at any time of the day, regardless of the time of the meal. Prior to initiation of drug therapy, the patient should begin to follow a standard hypocholesterolemic diet and continue to follow it during treatment. The dose of the drug should be selected individually depending on the goals of therapy and the therapeutic response to treatment, taking into account current recommendations for target lipid concentrations. The average initial dose is 5-10 mg.

Contraindications: – hypersensitivity to rosuvastatin or any of the components of the drug; – lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose); – children’s age up to 18 years; – liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times the upper limit of normal); – severe renal dysfunction (CC less than 30 ml / min); – myopathy and predisposition to the development of myotoxic complications; – simultaneous reception of cyclosporine; – in women: pregnancy, breastfeeding period, lack of adequate contraceptive methods.

Precautionary measures: Carefully: The presence of a risk of developing myopathy / rhabdomyolysis – renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity when using other HMG-CoA reductase inhibitors (statins) or fibrates; excessive alcohol consumption; age over 65; conditions in which an increase in the plasma concentration of rosuvastatin was noted; race (Mongoloid race); simultaneous appointment with fibrates; a history of liver disease; sepsis; arterial hypotension; major surgery, trauma, severe metabolic, endocrine, or fluid and electrolyte disturbances, or uncontrolled seizures. Side effects: Endocrine system: often – type 2 diabetes mellitus. From the side of the central nervous system: often – headache, dizziness. From the digestive tract: often – constipation, nausea, abdominal pain; rarely – pancreatitis. From the musculoskeletal system: often – myalgia; rarely – myopathy (including myositis), rhabdomyolysis. Other: often – asthenic syndrome. The following side effects have been reported in post-marketing use of Rosuvastatin: On the part of the hematopoietic system: unspecified frequency – thrombocytopenia. From the digestive tract: very rarely – jaundice, hepatitis; rarely – increased activity of “liver” transaminases; unspecified frequency – diarrhea.

Storage: Store at a temperature not exceeding 30 degrees.