tablets Rozart 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;

1 tablet is covered with a cover, contains rosuvastatin 5 mg or 10 mg or 20 mg, or 40 mg in the form of 5.21 mg, either 10.42 mg, or 20.84 mg, or 41.68 mg of rosuvastatin of calcium;

Excipients: microcrystalline cellulose, krospovidon, calcium hydrophosphate dihydrate, lactose, magnesium stearate

Cover:

• a tablet on 5 mg: gipromelloza, titan dioxide (E 171), lactose, macrogoal 3350, triacetin;
• a tablet on 10 mg: gipromelloza, titan dioxide (E 171), lactose, macrogoal 3350, triacetin, carmine (E 120);
• a tablet on 20 mg: gipromelloza, titan dioxide (E 171), lactose, macrogoal 3350, triacetin, carmine (E 120);
• a tablet on 40 mg: gipromelloza, titan dioxide (E 171), lactose, macrogoal 3350, triacetin, carmine (E 120).

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;
• hereditary intolerance of a galactose, lactose intolerance, glyukozo-galaktozny malabsorption.

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.

Route of administration

Before an initiation of treatment a standard gipokholesterinemichesky diet to which he has to adhere also during treatment. The dose should be selected individually, depending on the purpose of therapy and the response of the patient to treatment, being guided by the recommendations of the current standard managements.

Rozart Medicine can be accepted at any time, irrespective of meal.

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 Rozart use, usually easy and temporary. In controlled clinical trials less than 4% of the patients receiving Rozart 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 Rozart medicine and cyclosporine AUC value of rosuvastatin were on average about 7 times higher than

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

Storage conditions

to Store

at a temperature not above 25 °C out of children's reach.

Expiration date - 2 years.