Description
Latin name
MILARENA
Release form
Film-coated tablets, 0.3 mg, 3 mg.
10 tablets in a blister strip of PVC film laminated with Aklar ® laminate and aluminum printed varnished foil or aluminum printed varnished foil and aluminum foil laminated with polyvinyl chloride and polyamide film.
1 or 3 blister strip packaging along with instructions for use in a pack of cardboard.
Pharmacological action
A synthetic analogue of the pineal hormone (pineal gland) melatonin has an adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms. It increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxalkinase, which is involved in the synthesis of GABA, dopamine and serotonin. It regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature, positively affects the intellectual-mnestic functions of the brain, on the emotional and personal sphere. Promotes the organization of biological rhythm and the normalization of night sleep. Improves the quality of sleep, speeds up falling asleep, reduces the number of nightly awakenings, improves well-being after morning awakening, does not cause a feeling of lethargy, fatigue and fatigue upon awakening. Makes dreams more vivid and emotionally saturated.
Adapts the body to a quick change of time zones, reduces stress reactions, 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, growth hormone). Not addictive and addictive.
When ingested, it is rapidly and completely absorbed, it easily passes histohematological barriers, including the blood-brain barrier. It has a short half-life.
Indications
Desynchronosis (disturbance of the normal circadian rhythm) due to the rapid movement between the time zones of the Earth in violation of the light regime, 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 failure, severe renal impairment (for a dosage of 3 mg), pregnancy, breast-feeding, age up to 18 years (efficacy and safety have not been established).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding).
Special instructions
It is recommended that you avoid exposure to bright light during the use of Melaren ®.
It is necessary to inform women who want to become pregnant about the presence of a weak contraceptive effect in the drug.
Impact on the ability to drive vehicles and mechanisms
During the treatment period, care must be taken when driving and performing other potentially dangerous activities, requiring increased concentration of attention and speed of psychomotor reactions.
Composition
1 film-coated tablet contains: active ingredient melatonin – 0.30 mg or 3.00 mg
excipients: calcium hydrogen phosphate dihydrate? 67.37 / 64.67 mg, microcrystalline cellulose – 25.00 / 25.00 mg, croscarmellose sodium – 2.00 / 2.00 mg, povidone-K25? 3.33 / 3.33 mg, colloidal silicon dioxide? 0.50 / 0.50 mg, talc – 1.00 / 1.00 mg, calcium stearate? 0.50 / 0.50 mg shell: for dosage 0, 3 mg (hypromellose 62.50%, triethyl citrate 12.50%, titanium dioxide 25.00%)? 3.00 mg for a dosage of 3 mg (hypromellose 62.50%, macrogol-400 12.50%, titanium dioxide 24.21%, aluminum varnish FD&C blue No. 2 (12-14%) 0.28%, aluminum varnish FD&C blue No. 1 (1113%) 0.48%, quinoline yellow varnish 0.02%, iron dye black oxide 0.01%)? 3.00 mg.
Dosage and Administration
Inside.
In case of sleep disturbance, desynchronosis – 1 tablet once a day 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.
Side effects
Allergic reactions to drug components, headache, nausea, vomiting, diarrhea, morning drowsiness, edema are possible (usually in the first week of administration).
Drug Interactions
Incompatible with monoamine oxidase inhibitors (MAOs), glucocorticosteroids, cyclosporine.
Enhances the effect of drugs that inhibit the central nervous system and beta-blockers.
Concomitant use with non-steroidal anti-inflammatory drugs (NSAIDs) is not recommended.
Not recommended for use with hormonal drugs.
overdose No data on cases of melatonin overdose are available. Dose-dependent adverse reactions may increase.
Treatment: gastric lavage, symptomatic therapy.
Storage Conditions
In a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
2 years. Do not use the drug after the expiration date indicated on the package.
Deystvuyushtee substance
Melatonin
Terms and conditions
without prescription
Dosage form
tablets
Possible product names
Melarena tablets coated. 3 mg 10 pcs.
