Melaxen Balance (Melaxen Balance)

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:

    One film-coated tablet contains:

    Active active ingredient: Melatonin 0.3 mg.

    Excipients: calcium hydrophosphate, microcrystalline cellulose, magnesium stearate.

    Sheath: opadrai pink (Coconut oil, iron oxide red oxide, titanium dioxide, polydextrose, maltodextrin, talc, hypromellose).

    Description:

    Round, biconcave tablets coated with a film coat from light pink to pink with a separating risk on one side of the tablet.

    Type of tablet at the break: homogeneous mass from white to almost white, pinkish color is allowed due to the shell.

    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). It is synthesized from plant amino acids. Normalizes biological rhythms, has adaptogenic, sedative and hypnotic effects. Adapts the body to a rapid change of time zones. Normalizes seasonal and diurnal biorhythms, preventing the development of desynchronoses during changes in the light regime. Adapts the organism of meteosensitive people to changes in weather conditions. Regulates the "sleep-wakefulness" 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). Positively affects the intellectual and mnestic functions of the brain and the emotional-personal sphere. Reduces stressful reactions. Increases the concentration of gamma-amino acid (GABA) and serotonin inmiddle brain and hypothalamus, changes the activity of pyridoxal kinase involved in the synthesis of GABA, dopamine and serotonin. It shows immunostimulating and antioxidant properties. It has protective properties for free radical damage of deoxyribonucleic acid (DNA) and proteins, inhibits the processes of lipid peroxidation. Helps stimulate the production of interleukins and interferon lymphocytes. It contributes to the slowing down of pathological changes in cells, takes part in the regulation of antitumor immunity. Due to the rhythm-regulating, immunomodulating and antioxidant action it is able to inhibit the aging of cells. It inhibits the secretion of gonadotropin, to a lesser extent - other hormones adenohypophysis - corticotropin, thyroid stimulating hormone (TSH), growth hormone (STH) - Melatonin secretion is subordinated to the circadian rhythm determining the rhythm of gonadotropic effects and sexual functions. Synthesis and secretion of melatonin depend on the illumination - excess light inhibits its formation, reduced illumination increases the synthesis and secretion of the hormone.A low dosage of melatonin is suitable for long-term admission. 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:

    Prophylaxis and course treatment:

    - desynchronosis (disruption of normal circadian rhythm): due to rapid movement between Earth's time zones; in case of violation of the light regime, including, for people engaged in shift or shift work; at disturbance of biological rhythms in the elderly (age desynchronosis), against somatic diseases (arterial hypertension);

    - meteosensitivity;

    - Fatigue, sleep disturbances (including in elderly patients);

    Depressive syndrome.

    Contraindications:Hypersensitivity, allergic diseases; autoimmune diseases lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, chronic renal failure (CRF), pregnancy, lactation period, children's age (due to lack of data).
    Pregnancy and lactation:Contraindicated in pregnancy and lactation.
    Dosing and Administration:

    Inside.

    Adults 1 tablet for 30-40 minutes before bedtime once a day, long, the recommended course of admission is 6-8 weeks.

    Course intake 2-3 times a year for 6-8 weeks (in spring and autumn).

    Side effects:Allergic reactions to the drug components are possible. Headache, nausea, vomiting, diarrhea, morning drowsiness, swelling.
    Overdose:In case of accidental overdose: gastric lavage, symptomatic therapy.
    Interaction:Strengthens the effect of drugs that depress the central nervous system and beta-blockers. It is not recommended to take with non-steroidal anti-inflammatory drugs (NSAIDs). Incompatible with monoamine oxidase (MAO) inhibitors, glucocorticosteroids and cyclosporin.
    Special instructions:

    Avoid bright lighting.

    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 period of treatment, it is necessary to refrain from driving and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Film-coated tablets 0.3 mg.
    Packaging:

    For 30 or 60 tablets in a white bottle of high-density polyethylene with a screw cap made of the same material and a safety valve made of foil. The label is attached to the bottle, the bottle is tightened with a polyethylene film and, together with the instruction for use, is placed in a cardboard box.

    For 15 tablets in a blister of aluminum foil / PVC. Two or four blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of 10-30 ° C, in a dry place protected from light.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007884/10
    Date of registration:10.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Unipharm, Inc.Unipharm, Inc. USA
    Representation: & nbspUNIFARM, Inc. UNIFARM, Inc. USA
    Information update date: & nbsp27.04.2018
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