Description
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
The 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, 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.
Pharmacokinetics
When ingested quickly and completely absorbed, the histohematological barriers, including the blood-brain barrier, pass easily. It has a short half-life.
Indications
Prevention and treatment: 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 people engaged in shift or shift work.
Weather sensitivity.
Fatigue, sleep disturbances (including in elderly patients).
Depressive Syndrome.
Contraindications
Hypersensitivity to any of the components of the drug, violation of the skin at the site of application.
Experience in the use of Oddivok ® in the treatment of melanoma with a positive BRAF mutation in patients who have not previously received treatment is limited.
Patients with concomitant brain metastases, an active autoimmune disease, or diseases requiring treatment with systemic immunosuppressants were excluded from the main clinical study of PAC. In the absence of these data, nivolumab should be used with caution in these groups of patients after a careful assessment of the benefit-risk ratio based on individual indicators.
Selected patient groups
The following patient groups were not included in clinical trials:
patients with baseline functional status> 2, untreated brain metastases, autoimmune diseases, and patients 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).
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 a dosage of 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 (11 13%) 0.48%, quinoline yellow varnish 0.02%, iron dye black oxide 0.01%) 3.00 mg.
Dosage and Administration
Inside.
tablets of 0, 3 mg
1 tablet once a day 30-40 minutes before bedtime. The duration of the course of treatment is determined individually (from 6 to 8 weeks). Repeated courses are possible.
Side effects
Allergic reactions to the components of the drug, headache, nausea, vomiting, diarrhea, morning drowsiness, edema (usually in the first week of admission) are possible.
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
There are no data on overdose of melatonin. Perhaps an increase in dose-dependent adverse reactions.
Treatment: gastric lavage, symptomatic therapy.
Storage conditions
In a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
2 years.
Active ingredient
Melatonin
Form of Treatment
tablet
