Rosulip tablets 10mg, No. 28

primary hypercholesterolemia (Fredrickson type IIa) or mixed hypercholesterolemia (type IIb), as an adjunct to diet when diet and other non-drug treatments (eg exercise, weight loss) are insufficient;

homozygous hereditary hypercholesterolemia, as an adjunct to diet and other treatments aimed at lowering blood lipids (such as LDL apheresis), as well as in cases where these methods are not effective enough;

hypertriglyceridemia (type IV according to Fredrickson), as an addition to the diet;

to slow the progression of atherosclerosis, as an addition to the diet in patients, incl. for whom therapy is indicated to reduce the concentration of total cholesterol and cholesterol-LDL;

prevention of major cardiovascular complications (stroke, myocardial infarction, arterial revascularization) in adult patients without clinical signs of coronary heart disease, but with an increased risk of its development (age over 50 years for men and over 60 years for women, increased concentration of C -reactive protein (?2 mg / L) in the presence of at least one of the additional risk factors, such as arterial hypertension, low concentration of HDL-C, smoking, family history of early onset of coronary heart disease.

Inside, do not chew or crush the tablet, swallow it whole with water. RosulipЃ can be taken at any time of the day, regardless of food intake.

Before starting treatment with RosulipЃ, the patient should be prescribed a standard diet with a low CS content. The patient must follow a diet throughout the course of therapy. The dose of the drug should be selected individually, depending on the indications and the therapeutic response to treatment, taking into account the current recommendations for target lipid levels.

The recommended initial dose of RosulipЃ for patients starting to take the drug or transferred from taking other HMG-CoA reductase inhibitors is 5 or 10 mg once a day. When choosing an initial dose, one should be guided by the content of Xc in the patient and take into account the risk of developing cardiovascular complications, and it is also necessary to assess the potential risk of side effects. If necessary, the dose may be increased after 4 weeks.

After taking a dose in excess of the recommended initial dose for 4 weeks, its subsequent increase to 40 mg can be carried out only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired result therapy when taken in a dose of 20 mg and which will be under the supervision of a specialist. Particularly careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

For the treatment of patients over 65 years of age, the recommended starting dose is 5 mg. There is no need for other changes in the dose of the drug associated with the age of the patients.

No dose adjustment is required in patients with mild to moderate renal impairment. For patients with moderate renal impairment (Cl creatinine less than 60 ml / min), an initial dose of 5 mg is recommended. The 40 mg dose is contraindicated in patients with moderate renal impairment. In severe renal failure, RosulipЃ is contraindicated in any dose (see 'Contraindications').

With the appointment of doses of 10 and 20 mg, the recommended starting dose for patients of the Asian race is 5 mg. The appointment of the drug in a dose of 40 mg is contraindicated in patients of the Asian race (see 'Contraindications').

With the appointment of doses of 10 and 20 mg, the recommended starting dose for patients predisposed to myopathy is 5 mg. The appointment of the drug at a dose of 40 mg is contraindicated in patients with factors that may indicate a predisposition to the development of myopathy (see 'Contraindications').

After 2Ц4 weeks of therapy and / or with an increase in the dose of RosulipЃ, it is necessary to control the parameters of lipid metabolism, if necessary, a dose adjustment is required.

Film-coated tablets, 10 mg and 20 mg

hypersensitivity to rosuvastatin and other components of the drug;

liver disease in the active phase, including a persistent increase in serum transaminase activity or an increase in serum transaminase activity by more than 3 times compared with VGN;

severe renal dysfunction (Cl creatinine less than 30 ml / min);

myopathy;

concomitant use of cyclosporine;

pregnancy, lactation, as well as the lack of adequate methods of contraception in women with intact reproductive function;

predisposition to the development of myotoxic complications;

children under 18 years of age (due to the lack of sufficient clinical data, efficacy and safety have not been established, see 'Special instructions');

lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

With caution: risk of myopathy / rhabdomyolysis - renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity with the use of other HMG-CoA reductase inhibitors or fibrates; excessive alcohol consumption; patients over 65; conditions in which an increase in the plasma concentration of rosuvastatin is noted; patients of the Asian race; simultaneous use with fibrates; history of liver disease; sepsis; arterial hypotension; extensive surgical interventions, trauma; severe metabolic, endocrine or electrolyte disturbances or uncontrolled seizures.

Film-coated tablets, 40 mg

hypersensitivity to rosuvastatin and other components of the drug;

liver disease in the active phase, including a persistent increase in serum transaminase activity or an increase in serum transaminase activity by more than 3 times compared with VGN; there is no experience of using the drug in patients with a score above 9 on the Child-Pugh scale;

concomitant use of cyclosporine;

the presence of risk factors for the development of myopathy / rhabdomyolysis: renal failure of moderate severity (Cl creatinine less than 60 ml / min); hypothyroidism; a personal or family history of muscle disease; myotoxicity while taking other inhibitors of HMG-CoA reductase or fibrates in history; excessive alcohol consumption; conditions that can lead to an increase in the plasma concentration of rosuvastatin; simultaneous reception of fibrates; patients of the Asian race;

lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose);

pregnancy, lactation, as well as the lack of adequate methods of contraception in women with intact reproductive function;

children's age up to 18 years (due to the lack of sufficient clinical data, efficacy and safety have not been established, see 'Special instructions').

With care: renal failure of mild severity (Cl creatinine more than 60 ml / min); age over 65; history of liver disease; sepsis; arterial hypotension; major surgery, trauma, severe metabolic, endocrine, or electrolyte disturbances, or uncontrolled seizures.