tablets Rozvator are applied at the following indications:

• treatment of a hypercholesterolemia:
  • to adults, teenagers and children is more senior than 10 years with primary hypercholesterolemia (the IIa type, including with a heterozygous family hypercholesterolemia) or the mixed dislipidemiya (IIb type) as addition to a diet when observance of a diet and use of other non-medicament means (for example physical exercises, decrease in body weight) is insufficient;
  • at a homozygous family hypercholesterolemia as addition to a diet and other lipidosnizhayushchy remedies (for example an afereza ​​ LDL) or in cases when such treatment is inappropriate;
• prevention of cardiovascular disturbances: prevention to considerable cardiovascular disturbances at patients to whom, by estimates, the high risk of the first case of cardiovascular disturbance, in addition to correction of other risk factors threatens.

Structure

Active ingredient: rosuvastatin;

, a cover, contains rosuvastatin 10 mg or 20 mg in the form of calcium rosuvastatin;

Excipients: lactose monohydrate, cellulose microcrystalline, sodium, magnesium stearate, krospovidon;

Structure of a covering: Opadry pink 03B 24082 (gipromelloza, titan dioxide (E 171), macrogoal 400, ferrous oxide red (E 172)).

Contraindication

• hypersensitivity to rosuvastatin or to any of medicament excipients;
• a disease of a liver in an active phase, including an unknown etiology, with steady increase in activity of hepatic transaminases and also increase in level of any transaminase in blood serum more than by 3 times of rather upper bound of norm;
• heavy renal failure (clearance of creatinine <30 ml/min.);
• myopathy;
• concomitant use of cyclosporine;
• period of pregnancy and feeding by a breast and also to women of reproductive age, do not apply reliable means of contraception.

Prescribing of medicament in a dose of 40 mg is contraindicated to patients with the factors contributing to the development of a myopathy/rhabdomyolysis. Such factors include:

• moderate renal failures (clearance of creatinine <60 ml/min.);
• hypothyroidism;
• existence in the individual or family anamnesis of hereditary muscular diseases;
• existence in the anamnesis of a miotoksichnost against the background of intake of other inhibitors of GMG-KoA-reduktazy or fibrat;
• alcohol abuse;
• a state which can lead to increase in concentration of rosuvastatin in blood plasma;
• accessory to Mongoloid races;
• concomitant use of fibrat.

Prior to therapy of the patient to

to a standard diet with the lowered cholesterol content which to it should adhere also when performing therapy. Doses select individually, taking into account the purpose of therapy and the answer to it, observing the current agreed recommendations.

Rosuvastatin can be accepted at any time during the day, irrespective of meal.

Tablet should not be chewed or crushed. Swallow of a tablet entirely, washing down with water. If it is impossible to receive a necessary dose of rosuvastatin from the tablets Rozvatoru on 10 mg or 20 mg, it is necessary to use other medicines containing rosuvastatin in the necessary dosage.

to

Feature of use

Pregnant

It is contraindicated.

medicine Use to children only the expert has to carry out

.

Drivers

With care.

Overdose

Specific treatment of overdose. In case of overdose of the patient it is necessary to treat symptomatic and in case of need to host the supporting actions. It is necessary to control functions of a liver and the UK levels. The efficiency of a hemodialysis is improbable.

Side effects

Undesirable phenomena which are noted at medicament Rozvator use, usually easy and temporary. In controlled clinical trials less than 4% of the patients receiving Rozvator left a research because of side reactions.

gave the most frequent undesirable reactions to rosuvastatin according to clinical trials and wide experience of postregistration use Below.

Endocrine disorders: frequent (from ≥ 1/100 to <1/10) - diabetes.

from nervous system: frequent (from ≥ 1/100 to <1/10) - a headache, dizziness.

from digestive tract: frequent (from ≥ 1/100 to <1/10) - a constipation, nausea, abdominal pain.

from skeletal muscles and connective tissue: frequent (from ≥ 1/100 to <1/10) - myalgia.

during combined use of Rozvator medicine and cyclosporine AUC value of rosuvastatin were on average about 7 times higher than

, than those which were observed at healthy volunteers. Rozvator is contraindicated to patients who at the same time receive cyclosporine.

Storage conditions

to Store

at a temperature not above 30 °C out of children's reach.

Expiration date - 2 years.