Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbsptablets of prolonged action, coated
    Composition:

    1 tablet of prolonged action, coated with the film contains as active substance trimetazidine dihydrochloride 0.035 g;

    Excipients: cellulose microcrystalline - 0.1206 g, hypromellose - 0.0522 g, silicon dioxide colloid - 0.0011 g,magnesium stearate 0.0011 g, opadrai II (hypromellose, lactose monohydrate, triacetin, macrogol, titanium dioxide, iron oxide yellow, iron oxide red) 0.008 g

    Description:

    Round, biconvex tablets, covered with a shell of pink color.

    Pharmacotherapeutic group:antihypoxic agent
    ATX: & nbsp

    C.01.E.B   Other drugs for the treatment of heart disease

    C.01.E.B.15   Trimetazidine

    Pharmacodynamics:Trimetazidine has an antihypoxic effect. Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function.
    The cytoprotective effect is due to an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and fat oxidation blockade). Supports contractility of the myocardium, prevents intracellular depletion of adenosine triphosphate and phosphocreatinine. In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular concentration of potassium ions.Reduces intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion. It prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electric potential decreases the yield of creatine from the cells and the severity of ischemic myocardial injury. When the frequency of attacks of angina reduces (decreases nitrate consumption) after 2 weeks of treatment increases exercise capacity, reduced blood pressure drops. Improves hearing and results of vestibular samples in patients with pathology of ENT organs, reduces dizziness and tinnitus. In vascular pathology, the eye restores the functional activity of the retina.
    Pharmacokinetics:

    After taking the drug inside trimetazidine quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration in blood plasma - 5 hours. The maximum concentration after a single dose of 35 mg of trimetazidine is about 115 ng / ml. Easily penetrates through the histohematological barriers.The half-life is about 6.5 hours. Connection with blood plasma proteins - 16%. It is excreted by the kidneys (about 60% - unchanged).

    Indications:

    - ischemic heart disease: prevention of angina attacks (in complex therapy);

    - chorioretinal vascular disorders;

    - cochlear-vestibular disorders of ischemic nature (dizziness, tinnitus, hearing impairment).

    Contraindications:

    - hypersensitivity to any component of the drug;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption syndrome;

    - renal failure (creatinine clearance below 15 ml / min);

    - severe liver dysfunction;

    - pregnancy;

    - the period of breastfeeding;

    - age to 18 years (efficacy and safety not established).

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Angiosil® retard is prescribed 1 tablet (35 mg) 2 times a day during meals in the morning and in the evening. The duration of therapy is set individually.

    Side effects:

    The frequency of side effects noted when taking trimetazidine is given in the following gradation: very often (more than 1/10); often (more than 1/100,less than 1/10); infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000); very rarely (less than 1/10000), including individual messages.

    From the digestive system

    Often: abdominal pain, diarrhea, indigestion, nausea, vomiting.

    From the central nervous system

    Often: dizziness, headache, asthenia.

    Very rarely: extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.

    From the skin

    Often: skin rash, itching, hives.

    From the side of the cardiovascular system

    Rarely: orthostatic hypotension, "hot flashes" of blood to the skin of the face.

    Overdose:

    At present, no cases of drug overdose have been reported.

    Interaction:Interaction with other drugs is not described.
    Special instructions:

    The drug is not intended for relief of angina attacks. In the case of an attack of angina pectoris, the treatment should be reviewed and adapted.

    The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction.

    Due to the lack of relevant clinical data, the administration of the drug is not recommended for patients with severe liver function disorders.

    Effect on the ability to drive transp. cf. and fur:

    Angiosyl® retard has little effect on the ability to drive vehicles and perform work that requires an increased rate of psychomotor reactions.

    Form release / dosage:

    The tablets of the prolonged action covered with a cover, 35 mg.

    Packaging:

    For 10 or 14 tablets in a contour mesh package. For 3 or 6 contour cell packs (10 tablets each), or 2 or 4 circuit packs (14 tablets) together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002629
    Date of registration:20.11.2011
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.10.2015
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