Tablets "Romestin ^® 20" 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 (IІb 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 hypolipidemic remedies (for example an afereza ​​ LDL) or in cases when such treatment is inappropriate);
• 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 calcium rosuvastatin in terms of rosuvastatin 20 mg).

Excipients: microcrystalline cellulose; calcium hydrophosphate anhydrous; lactose, monohydrate; sodium of a kroskarmelloz; krospovidon; talc; stearic acid; Instacoat sol dye (gipromelloza, polyethyleneglycol, talc, titan dioxide (E 171)); diamond blue (E 133); tartrazine (E 102).

to

Drug is contraindicated to

Contraindication

:

• to patients with hypersensitivity to rosuvastatin or to any of medicament excipients;
• to patients with an active disease of a liver, including steady increases in serumal transaminases of an unknown etiology and any increases in transaminases in blood serum that exceeds the upper bound of norm (UBN) three times;
• to patients with a heavy renal failure (clearance of creatinine <30 ml/minute);
• to patients with a myopathy;
• to patients who at the same time receive cyclosporine;
• during pregnancy and feeding by a breast and also to women of reproductive age who do not use appropriate contraceptives.

to

Dose of 40 mg is contraindicated to patients with tendency to a myopathy/rhabdomyolysis.

treat factors of such risk:

• moderate renal failure (clearance of creatinine <60 ml/minute);
• hypothyroidism;
• existence in the personal or family anamnesis of hereditary muscular diseases;
• existence in the anamnesis of a miotoksichnost against the background of use of other inhibitors of GMG-KoA-reduktazy or fibrat;
• alcohol abuse;
• a situation which can lead to increase in concentration of medicament in blood plasma;
• belonging to Mongoloid race;
• simultaneous use of fibrat.

Route of administration

to the patient should appoint by

Before an initiation of treatment standard cholesterol - the lowering diet which should adhere also during treatment. The dose should be selected individually, depending on the purpose of therapy and efficiency of treatment, being guided by the recommendations of the current standard instructions.

can take the Drug at any time, irrespective of meal.

Treatment of a hypercholesterolemia

Recommended initial dose makes 5 or 10 mg orally 1 time a day as for patients who did not apply statines earlier, and to patients who applied other inhibitors of GMG-KoA-reduktazy before. When choosing an initial dose it is necessary to consider cholesterol levels at each certain patient and risk of cardiovascular disturbances in the future and also a likelihood of development of side reactions. In case of need it is possible to raise a dose to the following level in 4 weeks. Considering that against the background of use of medicament in a dose of 40 mg the undesirable reactions arise more often than at smaller doses, finally patients need to titrate a dose to 40 mg with a heavy hypercholesterolemia and high risk of cardiovascular disturbances (in particular at patients with a family hypercholesterolemia) at which it was not succeeded to achieve the treatment goal at use of a dose of 20 mg and which will be under regular observation. At the beginning of administration of medicament in a dose of 40 mg supervision of experts is recommended.

Prevention of disturbances from a cardiovascular system

data that reduction of risk of disturbances from a cardiovascular system medicament was used in a dose 20 mg a day Exist.

Children by

Use of medicament for children only the expert has to carry out

.

to Apply

to children and teenagers aged from 10 up to 17 years (boys at a stage of development of the II and above on Tannera and girls at whom periods began less than a year ago).

Initial daily dose for children and teenagers with a heterozygous family hypercholesterolemia makes 5 mg a day. The medicament usually should be taken orally in doses from 5 mg to 20 mg of 1 times a day. It is necessary to raise a dose according to the individual response of the child to treatment and tolerance of drug, following recommendations about treatment of children.

rosuvastatin to children and teenagers should appoint by

before therapy a standard gipokholesterinemichesky diet which patients have to observe also during treatment. Safety and efficiency of medicine in doses did not investigate more than 20 mg in this population.

not to apply

Tablet on 40 mg to children.

Experience of treatment of children aged up to 10 years is limited to use of medicament for a small amount of patients (aged from 8 up to 10 years) with a homozygous family hypercholesterolemia. Thus, medicament is not recommended to be used to children up to 10 years.

to

Pregnant

to

Drug is contraindicated to

Feature of use

during pregnancy or feeding by a breast.

during intake of this medicine appropriate means of contraception have to apply

Woman of reproductive age.

As cholesterol and other products of biosynthesis of cholesterol are significantly important

for fetation, the potential risk of inhibition of GMG-KoA-reduktazy exceeds possible advantage of use of medicament during pregnancy. Researches on animals showed limited proofs of reproductive toxicity. If the patient becomes pregnant during medicament use, treatment should be stopped immediately.

Rosuvastatin gets into milk of rats. The person has no data on penetration of medicament into breast milk.

Drivers

did not carry out

Research on definition of influence of rosuvastatin on ability to run motor transport and to work with mechanisms. However, considering pharmakodinamichesky properties, it is improbable that this medicament can influence such ​​ ability. At control of motor transport or work with mechanisms it is necessary to consider an opportunity dizziness during treatment.

Overdose

is not present

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 rosuvastatin use, usually easy and temporary. Less than 4% of the patients accepting rosuvastatin in controlled clinical trials stopped treatment because of development of side reactions.

by

gave a profile of undesirable reactions to rosuvastatin according to clinical trials and wide experience of postregistration use of medicaments of rosuvastatin Below. Undesirable reactions are classified by frequency and the system and organ classes (SOC).

undesirable reactions are distributed by

On frequency as follows: often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), it is rare (≥ 1/10000 and <1/1000), is very rare (<1/10000), unknown frequency (it is impossible to estimate on the available data).

from blood and lymphatic system: seldom - thrombocytopenia.

from the immune system: seldom - reactions of hypersensitivity, including a Quincke's disease.

Endocrine disturbances: often - diabetes.

Mental disorders: frequency is unknown - a depression.

from nervous system: often - a headache, dizziness; very seldom - a polyneuropathy, memory loss; frequency is unknown - a peripheral neuropathy, sleep disorders (including insomnia and nightmares).

from respiratory organs, a thorax and mediastinum: frequency is unknown - cough, short wind.

from digestive tract: often - a constipation, nausea, an abdominal pain; seldom - pancreatitis; frequency is unknown - diarrhea.

from digestive system: seldom - increase in level of hepatic transaminases; very seldom - jaundice, hepatitis.

from skin and hypodermic cellulose: infrequently - an itching, rash, urticaria; frequency is unknown - Stephens-Johnson's syndrome.

from skeletal muscles and connective tissue: often - myalgia, it is rare - a myopathy (including a miositis), a rhabdomyolysis; very seldom - an arthralgia; frequency is unknown - the disturbances from sinews sometimes complicated by gaps, the immunomediated necrotizing myopathy.

from kidneys and an urinary system: very seldom - a hamaturia.

from a reproductive system and mammary glands: seldom - a gynecomastia.

General disturbances and condition of the injection site: often - an asthenia; frequency is unknown - hypostasis.

Storage conditions

to Store

in original packing at a temperature not above 30 °C, out of children's reach.

Expiration date - 3 years.