Melaren® (Melarena)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMelatoninMelatonin
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    • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance melatonin - 0.30 mg or 3.00 mg;

    Excipients: calcium hydrophosphate dihydrate is 67.37 / 64.67 mg, microcrystalline cellulose is 25.00 / 25.00 mg, croscarmellose sodium is 2.00 / 2.00 mg, povidone-K25 is 3.33 / 3.33 mg, silicon dioxide colloid - 0.50 / 0.50 mg, talc - 1.00 / 1.00 mg, calcium stearate - 0.50 / 0.50 mg; shell: for dosage of 0.3 mg (hypromellose 62.50%, triethyl citrate 12.50%, titanium dioxide 25.00%) - 3.00 mg; for the dosage of 3 mg (hypromellose 62.50%, macrogol-400 12.50%, titanium dioxide 24.21%, lacquer aluminum FD&C blue № 2 (12-14%) 0,28%, aluminum varnish FD&C blue No. 1 (11-13%) 0.48%, lacquinolino yellow 0.02%, iron dye oxide black 0.01%) - 3.00 mg.

    Description:

    Round, biconvex tablets, covered with a film membrane from white to almost white (for a dosage of 0.3 mg) or blue (for a dosage of 3 mg) of color. The core is from white to almost white.

    Pharmacotherapeutic group:Adaptogenic agent
    ATX: & nbsp

    N.05.C.H.01   Melatonin

    N.05.C.H   Melatonin receptor agonists

    Pharmacodynamics:

    Synthetic analogue of the hormone of the pineal body (epiphysis) of melatonin; has an adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms. Increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in middle brain and hypothalamus, changes the activity of pyridoxal kinase involved in the synthesis of GABA, dopamine and serotonin. Regulates the sleep-wake cycle, diurnal changes in locomotor activity and body temperature, positively influences the intellectual and mnestic functions of the brain, on the emotional-personal sphere. Promotes the organization of biological rhythm and normalization of night sleep. It improves the quality of sleep, speeds up falling asleep, 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. Makes dreams brighter and emotionally saturated.

    Adapts the body to a rapid change of time zones, reduces stressful reactions, regulates neuroendocrine functions.Adapts the organism of meteosensitive people to changes in weather conditions. It shows immunostimulating and antioxidant properties. It inhibits the secretion of gonadotropins, to a lesser extent - other hormones adenohypophysis (corticotroin, thyroid-stimulating hormone, growth hormone). 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:

    Tablets by 0,3 mg

    Prophylaxis and course treatment:

    Desynchronosis (disruption of normal circadian rhythm) due to rapid movement between time zones of the Earth; when the light regime is violated, including, for people engaged in shift work or shift work.

    Meteosensitivity.

    Fatigability, sleep disturbances (incl. In elderly patients).

    Depressive syndrome.

    Tablets of 3 mg

    Desynchronosis (disruption of normal circadian rhythm) due to rapid movement between time zones of the Earth; when the light regime is violated, including, for people engaged in shift work or shift work.

    Sleep disturbances.

    Contraindications:

    Hypersensitivity to melatonin and other components of the drug; autoimmune diseases, allergic diseases; lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, chronic renal failure; severe renal dysfunction (for a dosage of 3 mg); pregnancy, the period of breastfeeding; age to 18 years (efficacy and safety of use not established).

    Dosing and Administration:

    Inside.

    Tablets of 0.3 mg

    1 tablet once a day for 30-40 minutes before bedtime. The duration of the course of treatment is determined individually (from 6 to 8 weeks). Repeat courses are possible.

    Tablets of 3 mg

    In case of sleep disturbance, desynchronosis - 1 tablet once a day for 30-40 minutes before bedtime. When used as an adaptogen when changing time zones - 1 day before the flight and in the next 2-5 days - 1 tablet for 30-40 minutes before bedtime.

    The maximum daily dose is 6 mg.

    Side effects:

    Allergic reactions to drug components, headache, nausea, vomiting, diarrhea, morning drowsiness, edema (usually in the first week of admission) are possible.

    Overdose:

    Data on cases of overdose of melatonin are absent.Possible intensification of dose-dependent adverse reactions.

    Treatment: gastric lavage, symptomatic therapy.

    Interaction:

    Incompatible with monoamine oxidase (MAO) inhibitors, glucocorticosteroids, cyclosporin.

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

    It is not recommended simultaneous reception with non-steroidal anti-inflammatory drugs (NSAIDs).

    It is not recommended to take together with hormonal drugs.
    Special instructions:

    It is recommended to avoid exposure to bright light during the period of application of the preparation of Mélaren®.

    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, care must be taken when driving vehicles and performing other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Film-coated tablets, 0.3 mg, 3 mg.

    Packaging:

    10 tablets in a contour mesh package made of polyvinylchloride film, laminated with Aklar®, and foil of aluminum printed lacquered or foil of aluminum printed lacquered and aluminum foil, laminated with polyvinylchloride and polyamide film.

    1 or 3 contour packs together with instructions for use 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:

    2 years. Do not use the drug after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002831
    Date of registration:21.01.2015 / 18.10.2016
    Expiration Date:21.01.2020
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.04.2018
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