Tablets "Atoris ^® " are applied at the following indications:

• prevention of cardiovascular diseases;
• a lipidemia (primary hypercholesterolemia (heterozygous family and single) and the mixed dislipidemiya (the IIa and IIb type on Fredrikson's classification); a gipertriglitseridemiya (type IV on Fredrikson's classification); primary disbetalipoproteinemiya (type III on Fredrikson's classification); homozygous family hypercholesterolemia; a heterozygous family hypercholesterolemia at patients of children's age (at the age of 10-17 years)).

Structure

One tablet, coated, contains (active ingredient) of 20 mg of an atorvastatin in the form of an atorvastatin of calcium.

Excipients: povidone, sodium lauryl sulfate, calcium carbonate, cellulose microcrystalline, lactoses monohydrate, sodium of a kroskarmelloz, magnesium stearate, cover: talc, polyvinyl alcohol, macrogoal 3000, titan dioxide (E 171).

Contraindication

• hypersensitivity to any ingredient of drug;
• liver diseases in a sharp phase or permanent increase (unknown genesis) in levels of transaminases in blood serum by 3 times and more;
to
• medicament is contraindicated to pregnant women, women during feeding by a breast, and to women of reproductive age who do not apply suitable methods of contraception.

Route of administration

Prior to medicament treatment the level of a hypercholesterolemia and to control observance of the corresponding diet, physical activities, degrowth of a body at patients with obesity and treatment of other main medical problems of patients. At administration of medicament "Atoris ^® " the patient has to adhere to the standard diet reducing cholesterol level.

Lipidemia and the mixed dislipidemiya

Recommended initial dose of an atorvastatin of 10 mg or 20 mg of 1 times a day. For patients who demand considerable decrease in level of LDL cholesterol (more than for 45%) therapy it is possible to begin with a dose 40 mg of 1 times a day.

can take the Drug a single dose in any hours and irrespective of meal. The initial and supporting doses are selected individually, depending on the LDL level XC, by the purposes of treatment and the answer. After an initiation of treatment and/or after titration of a dose of medicament it is necessary to control the level of lipids within 2-4 weeks and as appropriate to modify a dose.

Heterozygous family hypercholesterolemia at patients of children's age (aged from 10 up to 17 years)

Recommended initial dose of an atorvastatin of 10 mg/days, usual range of doses makes from 10 mg to 20 mg orally 1 time a day. Doses of medicament should be selected individually according to the recommended treatment purpose. The therapeutic answer is shown within 2-4 weeks and supported at long therapy. It is necessary to carry out correction of a dose with an interval of 4 weeks or more.

Dose of an atorvastatin at patients with a homozygous family hypercholesterolemia makes

from 10 mg to 80 mg a day. Atorvastatin it is necessary to apply as addition to other hypolipidemic methods of treatment (for example aferez LDL) or if hypolipidemic methods of treatment are inaccessible.

Children (heterozygous family hypercholesterolemia)

only the doctors having experience of treatment of a lipidemia at children; patients should carry out regularly repeated control for therapy assessment.

For patients aged from 10 years the recommended dose of an atorvastatin makes 10 mg or 20 mg a day. Doses of medicament should be selected individually. It is necessary to carry out correction of a dose with an interval of 4 weeks or more.

. In a narrow controlled research the significant influence of medicament on growth or puberty of boys or on duration of a menstrual cycle at girls was not revealed. Teenage girls should be consulted rather acceptable methods of contraception during the treatment period.

at treatment of patients aged up to 10 years. For patients of this group of more reasonable there can be other pharmaceutical form / dosing.

It was reported about a research of clinical performance of use of an atorvastatin in doses up to 80 mg/days within one year at patients with a homozygous family hypercholesterolemia which included 8 patients of children's age.

Feature of use

Drivers

Are not present messages about influence of an atorvastatin on ability to drive the car and to use technical devices. But during medicament use some patients can test dizziness and myotonia. Therefore during treatment it is necessary to be careful at control of motor transport or work with other mechanisms.

Overdose

Specific treatment of overdose. In case of overdose of the patient it is necessary to treat symptomatic and if necessary to take the supporting measures. It is necessary to carry out analyses of function of a liver and to control the UK level in blood serum. From = for high extent of linking of medicament with proteins of plasma should not expect increase in clearance of medicament by means of a hemodialysis.

Side effects

According to information of clinical trials at the patients receiving treatment atorvastatiny such side reactions which led to medicament withdrawal and happened to frequency, above (> 2%), than in group of placebo: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), increase in level of alaninaminotranspherase (ALT) (0.4%) and liver enzymes (0.4%).

Most frequent side reactions (≥ 2% in comparison with placebo) irrespective of the reason, at the patients receiving placebo in researches (n = 8755), were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), extremity pain (6.0%) and infection of urinary tract (5.7%).

to Store

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

Expiration date - 2 years.