Active substanceMeldoneyMeldoney
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance - Meldonium dihydrate 250 mg;

    Excipients - potato starch, dried, silicon dioxide, calcium stearate; capsule (body and lid) - titanium dioxide (E 171), gelatin.

    Description:

    Hard gelatin capsules No. 1 in white. The contents are a white crystalline powder with a faint odor. The powder is hygroscopic.

    Pharmacotherapeutic group:Metabolic means
    ATX: & nbsp

    C.01.E.B.22   Meldoney

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

    Pharmacodynamics:

    Meldonium is a structural analogue of the precursor of carnitine-gamma-butiro-betaine (GBB), a substance that is found in every cell of the human body.

    In conditions of increased load meldoon restores the balance between delivery and the need for cells in oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; has also a tonic effect. As a result of its application, the body's resistance to stresses increases and the ability to quickly restore energy reserves.

    The drug has a stimulating effect on the central nervous system (CNS) - an increase in motor activity and physical endurance. Due to these properties, MILDRON® is also used to increase physical and mental performance.

    Pharmacokinetics:

    After ingestion, the drug is rapidly absorbed, bioavailability is 78%.

    The maximum concentration (Cmax) in the blood plasma is achieved 1-2 hours after ingestion. Metabolized in the body mainly in the liver with the formation of two major metabolites, which are excreted by the kidneys. The half-life (T1/2) when taken orally depends on the dose, is 3-6 hours. The trace concentrations of the drug persist for a long time in the body.

    Indications:

    Reduced performance, mental and physical overload.

    Contraindications:

    Hypersensitivity to meldonia or any other component of the drug.

    Increase in intracranial pressure (with violation of venous outflow, intracranial tumors).

    Pregnancy and the period of breastfeeding.

    Age under 18 years (safety not confirmed).

    Carefully:With diseases liver and / or kidney.
    Pregnancy and lactation:

    Safety of use in pregnant women has not been studied, therefore, in order to avoid possible adverse effects on the fetus, the use of the drug in pregnant women is contraindicated.

    Withdrawal from milk and the impact on the health of the newborn have not been studied, therefore, if a drug is needed, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside.

    The daily dose for adults is 500 mg (2 capsules). The whole dose is applied in the morning in one session or divided into 2 divided doses.

    The course of treatment is 10-14 days.

    If necessary, the treatment is repeated after 2-3 weeks.

    In connection with the possible exciting effect of the drug is recommended to use in the morning.

    Side effects:

    Meldonium, as a rule, is well tolerated. However, in susceptible patients, as well as in cases of exceeding the recommended dose, it is possible occurrence of undesirable reactions. Unwanted drug reactions are grouped according to the system-organ classes according to the following frequency gradation: very often (≥1/10), often (≥1 / 100 and <1/10) infrequently (≥1 / 1000 and <1/100) , rarely (≥1 / 10,000 and <1/1000) and very rarely (<1/10 000), the frequency is unknown - according to the available data, the frequency can not be estimated.

    On the part of the blood and lymphatic system

    Frequency unknown: eosinophilia.

    From the immune system

    Often: allergic reactions (redness skin, rashes, itching, swelling).

    From the heart

    Very rarely: tachycardia.

    From the side of the vessels

    Rarely: lowering of arterial pressure.

    From the gastrointestinal tract

    Often: dyspeptic phenomena

    From the nervous system

    Often: headaches;

    The frequency is unknown: excitation.

    Common violations

    The frequency is unknown: general weakness.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    No cases of an overdose of milling were reported. The drug is low in toxicity and does not cause severe adverse reactions.

    Symptoms: lowering of arterial pressure, accompanied by headache, tachycardia, dizziness and general weakness.

    Treatment: symptomatic.

    In severe overdose, it is necessary to monitor the functions of the liver and kidneys.

    Interaction:

    Meldonium can be used simultaneously with nitrates of prolonged action and other antianginal agents,cardiac glycosides and diuretics. It can also be combined with anticoagulants, antiaggregants, antiarrhythmics drugs and other drugs that improve microcirculation. Meldoney can enhance the action of nitroglycerin, nifedipine, beta-adrenoblockers, other antihypertensive agents and peripheral vasodilators. Simultaneous use of the drug together with other preparations of meldonia is not allowed, since the risk of undesirable reactions may increase.

    Special instructions:

    Patients with chronic liver and kidney disease should be careful with prolonged use of the drug. If you need a long (more than a month) use of the drug should consult with a specialist. The drug can give a positive result in the doping control.

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

    There is no evidence of adverse effects on ability to manage transport means of carrying out potentially dangerous activities that require increased concentration of attention and the speed of psychomotor reactions.

    Form release / dosage:

    Capsules 250 mg.

    Packaging:

    10 capsules in a contour cell box made of polyvinyl chloride film with polyvinylidene chloride coating and aluminum foil. 4 contour squares with instructions for use in cardboard pack.

    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N016028 / 01
    Date of registration:30.09.2009 / 21.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp09.06.2018
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