Tablets " ^{Sandoz Rosuvastatin ®} " 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), (except for a family heterozygous hypercholesterolemia) or the mixed dislipidemiya (IIb type) as addition to a dietotherapy, when a diet or other non-medicament methods of treatment (for example physical exercises, decrease in body weight) it are p insufficient;
• at a homozygous family hypercholesterolemia, as addition to a diet and other measures for decrease in maintenance of lipids (for example an afereza ​​ lipoproteins of low density) or in cases when performing such therapy is inexpedient;
• prevention of cardiovascular disturbances (prevention of 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 (one tablet contains 20 mg of rosuvastatin (in the form of calcium rosuvastatin)).

Excipients: anhydrous lactose, silicon dioxide colloidal anhydrous, cellulose microcrystalline silikatizirovanny, starch corn, talc, the sodium stearylfumarating; cover: the gipromelloza, attracts (E 421), a macrogoal 6000, the titan dioxide (E 171), ferrous oxide yellow (E 172), ferrous oxide red (E 172), talc.

Contraindication

• hypersensitivity to rosuvastatin or to excipients as a part of drug;
• a disease of a liver in an active phase, including at permanent increase in level of serumal transaminases of an unknown etiology and also at increase in level of serumal transaminases that exceeds the upper bound of norm (UBN) more than by 3 times;
• heavy renal failures (clearance of creatinine <30 ml/minute);
• myopathy;
• simultaneous use of cyclosporine;
• during pregnancy and feeding by a breast and also to women of reproductive age who do not apply appropriate means of contraception.

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.

Treatment of a hypercholesterolemia

Recommended initial dose makes 5 or 10 mg orally 1 time a day for patients who did not receive medicaments of group of statines earlier, or the patients receiving earlier other inhibitors of GMG-KoA-reduktazy. When choosing an initial dose it is necessary to consider individual indicators, such as level of cholesterol and risk of cardiovascular disturbances in the future and also a likelihood of development of side reactions. Correction of a dose with its increase is in case of need carried out in 4 weeks. Because of increase in frequency of side reactions the increase in a dose to 40 mg is recommended only at treatment of patients with a hypercholesterolemia of high severity, at high risk of emergence of cardiovascular disturbances (in particular at patients with a family hypercholesterolemia) when administration of medicament in a dose of 20 mg a day does not provide desirable result, on condition of carrying out regular medical control.

Prevention of disturbances from a cardiovascular system

during the research of influence of medicament on reduction of risk of complications from a cardiovascular system medicament was used in a dose 20 mg a day.

Children

In pediatric practice medicament is appointed only by the doctor. To apply to children and teenagers aged from 10 up to 17 years (boys - on achievement of pubertal development of a stage it is I or above on Tannera, girls - not earlier than in 1 year after menarche). The initial daily dose for children and teenagers with a heterozygous family hypercholesterolemia makes 5 mg a day. Usual range of doses - 5-20 mg orally 1 time a day. Increase in a dose is carried out taking into account individual reaction and shipping, according to recommendations to use in pediatric practice. Before therapy by rosuvastatin the child should appoint a standard diet with the low content of cholesterol, it is necessary to adhere to a diet also during performing therapy. Safety and efficiency of use of medicament in a dose of 20 mg in therapy of this population did not investigate.

Experience of use of medicament in therapy of children aged up to 10 years is limited to a small amount of patients (aged from 8 up to 10 years) with a homozygous family hypercholesterolemia. So, rosuvastatin is not recommended for use in therapy of children up to 10 years.

Feature of use

Drivers

Research on influence of rosuvastatin on ability to run vehicles or other mechanisms. At control of motor transport or work with other mechanisms it is necessary to consider a possibility of dizziness during treatment.

Overdose

in case of overdose should provide to the patient symptomatic treatment, if necessary to carry out maintenance therapy. Monitoring of functions of a liver and level of a creatine kinase is necessary. Carrying out a hemodialysis is probably inexpedient.

Side effects

Undesirable phenomena which are noted at rosuvastatin use, usually easy and temporary.

from an endocrine system: often (≥ 1/100 and <1/10) - diabetes.

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

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

from a musculoskeletal system and connective tissues: often (≥ 1/100 and <1/10) - myalgia.

to Store

in original packing for protection against moisture at a temperature not above 25 °C, out of children's reach.

Expiration date - 2 years.