Composition
1 film-coated tablet contains: Active ingredient Melatonin-0.30 mg or 3.00 mg; Excipients: Calcium hydrophosphate dihydrate-67.37 / 64.67 mg Microcrystalline cellulose-25.00 / 25.00 mgCroscarmellose sodium-2.00 / 2.00 mg Povidone-K 25 ‒ 3,33/ 3,33 Colloidal silicon dioxide-0.50 / 0.50 mg, Talc-1.00 / 1.00 mg, Calcium stearate-0.50 / 0.50 mg; Shell: For the dose of 0.3 mg (hypromellose 62,50%, triethylcitrate 12,50%, titanium dioxide 25,00%) ‒ 3,00 mg;dosage 3 mg (hypromellose 62,50%, macrogol-400 12,50%, titanium dioxide from 24,21%, lacquer-aluminum, FD & C blue No. 2 (12-14%) of 0.28%, lacquer-aluminum, FD & C blue No. 1 (11-13%) of 0.48%, quinoline yellow lacquer and 0.02%, dye iron oxide black 0,01%) ‒ 3,00 mg.
Pharmacological action
Synthetic analog of the pineal gland hormone melatonin; has an adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms. Increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxal kinase, which is involved in the synthesis of GABA, dopamine and serotonin. Regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature, has a positive effect on the intellectual and mnestic functions of the brain, on the emotional and personal sphere. Promotes the organization of biological rhythm and normalization of night sleep. Improves the quality of sleep, accelerates falling asleep, reduces the number of nighttime awakenings, improves well-being after waking up in the morning, does not cause feelings of lethargy, weakness and fatigue when waking up. It makes your dreams more vivid and emotionally intense. Adapts the body to fast jet lag, reduces stress responses, and regulates neuroendocrine functions. Adapts the body of weather-sensitive people to changes in weather conditions. It exhibits immunostimulating and antioxidant properties. Inhibits the secretion of gonadotropins, to a lesser extent-other hormones of the adenohypophysis (corticotropin, thyroid-stimulating hormone, somatotropic hormone). It is not addictive or addictive. When taken orally, it is quickly and completely absorbed, easily passes histohematic barriers, including the blood-brain barrier. It has a short half-life.
Indications
- Desynchronosis (violation of the normal circadian rhythm) due to rapid movement between time zones of the Earth; when the light regime is violated, including in people engaged in shift or shift work.
- Sleep disorders.
Contraindications
Hypersensitivity to melatonin and other components of the drug; autoimmune diseases, allergic diseases; lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, chronic renal insufficiency; severe renal function disorders (for a dosage of 3 mg); pregnancy, breast-feeding; age up to 18 years (efficacy and safety of use have not been established).
Side effects
Possible allergic reactions to the components of the drug, headache, nausea, vomiting, diarrhea, morning drowsiness, edema (usually in the first week of use).
Interaction
Incompatible with monoamine oxidase (MAO) inhibitors, glucocorticosteroids, cyclosporine. Increases the effect of drugs that depress the central nervous system and beta-blockers. Concomitant use with nonsteroidal anti-inflammatory drugs (NSAIDs) is not recommended. It is not recommended to take it together with hormonal medications.
How to take, course of use and dosage
In case of sleep disorders, 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 30-40 minutes before bedtime. The maximum daily dose is 6 mg.
Overdose
There are no data on cases of melatonin overdose. Possible increase in dose-dependent adverse reactions. Treatment: gastric lavage, symptomatic therapy.
Special instructions
During the use of Melarena®, it is recommended to avoid exposure to bright light. It is necessary to inform women who want to get pregnant about the presence of a weak contraceptive effect of the drug. Effects on the ability to drive vehicles and mechanisms During treatment, care should be taken when driving vehicles and performing other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Film-coated tablets,0.3 mg,3 mg. 10 tablets in a contour cell package made of polyvinyl chloride film laminated with Aklar® material, and aluminum foil printed varnished or aluminum foil printed varnished and aluminum foil laminated with polyvinyl chloride and polyamide film. 1 or 3 contour cell packages together with instructions for use in a cardboard pack.
Storage conditions
Store in a dry place protected from light at a temperature not exceeding 25° C. Keep out of reach of children.
Shelf
life is 2 years. Do not use the product after the expiration date indicated on the package.
Active ingredient
Melatonin
Dosage form
Tablets
Description
For adults
Indications
Jet Lag, Depression, Insomnia, Weather Sensitivity
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Side effects of Melarena pills 3mg, 30pcs.
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