Active substanceMelatoninMelatonin
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: Melatonin 1.5 mg / 3 mg;

    Excipients: microcrystalline cellulose, carboxymethyl starch sodium (sodium starch glycolate), calcium hydrophosphate dihydrate, mannitol, macrogol 6000 (polyethylene glycol 6000), magnesium stearate;

    excipients for the shell:

    Opadrai II [alcohol polyvinyl, titanium dioxide, macrogol, talc].

    Description:

    Round biconvex tablets covered with a film coat of white or almost white color.

    Pharmacotherapeutic group:Adaptogenic agent
    ATX: & nbsp

    N.05.C.H.01   Melatonin

    N.05.C.H   Melatonin receptor agonists

    Pharmacodynamics:

    It is a synthetic analogue of the hormone of the pineal gland (epiphysis). Normalizes circadian rhythms.Regulates the sleep-wake cycle, diurnal changes in locomotor activity and body temperature. Promotes the normalization of night sleep (speeds up sleep, improves sleep quality, reduces the number of nocturnal awakenings, improves well-being after a morning awakening, does not cause a feeling of sluggishness, weakness and fatigue when awakening, dreams become brighter and emotionally saturated).

    Adapts the body to a rapid change of time zones, reduces stress reactions.

    It shows immunostimulating and expressed antioxidant properties.

    It inhibits the secretion of gonadotropins, to a lesser extent - other hormones of adenohypophysis - corticotropin, thyrotropin and somatotropin.

    Does not cause addiction and dependence.

    Pharmacokinetics:

    When ingested quickly and completely absorbed, easily passes the histohematological barriers, including the blood-brain barrier. Has a short half-life.

    Indications:

    As a hypnotic.

    As adaptogen for the normalization of biological rhythms.
    Contraindications:

    Hypersensitivity, pronounced impaired renal function, autoimmune diseases, leukemia, lymphoma, allergic reactions,lymphogranulomatosis, myeloma, epilepsy, diabetes mellitus, chronic renal failure, pregnancy and the period of breastfeeding.

    Pregnancy and lactation:

    The use of melatonin is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Inside. Adults 1.5-3 mg for 30-40 minutes before going to bed once a day.

    As an adaptogen when changing time zones: 1 day before the flight and in the next 2-5 days for 3 mg for 30-40 minutes before bedtime. The maximum daily dose to 6 mg per day.

    Side effects:

    From the immune system: allergic reactions.

    From the central nervous system: headache, morning drowsiness.

    From the digestive system: nausea, vomiting, diarrhea.

    Other: swelling in the first week of admission.

    Overdose:

    Symptoms. Increased severity of side effects.

    Treated. Gastric lavage, symptomatic therapy.

    Interaction:

    Melatonin enhances the effect of drugs that depress the central nervous system and beta-blockers.

    It is not recommended to take melatonin together with hormonal drugs.

    Melatonin is incompatible with monoamine oxidase (MAO) inhibitors, glucocorticosteroids and cyclosporin.

    Special instructions:

    During the period of application of the drug, it is recommended to avoid staying in bright light.

    It is necessary to inform women who want to become pregnant, about the presence of a weak contraceptive effect in the drug.

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

    During the treatment period, it is necessary to refrain from driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, film-coated, 1.5 mg, 3 mg.

    Packaging:

    By 6, 10, 12, 20, 24 tablets in a contour cell box made of a polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 4 contour packs of 6 tablets together with the instructions for use are placed in a pack of cardboard.

    For 1, 2 contour cell packs of 10 tablets together with the instructions for use are placed in a pack of cardboard.

    For 1, 2 contour cell packs of 12 tablets together with the instructions for use are placed in a pack of cardboard.

    On 1 circuit cell pack of 20 tablets together with the instructions for use are placed in a pack of cardboard.

    On 1 circuit cell pack of 24 tablets together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003266
    Date of registration:26.10.2015 / 26.10.2017
    Expiration Date:26.10.2020
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.04.2018
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