Melarena, 3 mg 10 pcs

Synthetic analogue of the pineal body hormone (epiphysis) melatonin; has adaptogenic, sedative, and hypnotic effects. It normalizes circadian rhythms.

Increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxal kinase, 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 mental functions of the brain, on the emotional and personality sphere.

It promotes the organization of the biological rhythm and the normalization of night sleep.

It improves the quality of sleep, accelerates falling asleep, reduces the number of night awakenings, improves the sense of well-being after the morning awakening, does not cause the feeling of dullness, weariness and fatigue upon awakening.

Makes dreams more vivid and emotionally charged.

Adapts the body to rapid change of time zones, reduces stress reactions, regulates neuroendocrine functions.

Adapts the body of people sensitive to changes in weather conditions. It shows immune-stimulating and antioxidant properties.

Inhibits secretion of gonadotropins, to a lesser extent – other adenohypophysis hormones (corticotropin, thyroid hormone, somatotropic hormone). It is not addictive and not dependent.

When administered orally it is quickly and completely absorbed, easily passes through histohematic barriers including the blood-brain barrier. It has a short half-life.

Indications

Desynchronosis (disruption of the normal circadian rhythm) due to rapid movement between time zones of the Earth; in case of violation of the light regime, including for people engaged in shift work or rotational work.
Sleep disorders.

Pharmacological effect

A synthetic analogue of the pineal body (epiphysis) 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.

Helps organize biological rhythm and normalize night sleep.

Improves sleep quality, speeds up falling asleep, reduces the number of night awakenings, improves well-being after waking up in the morning, does not cause a feeling of lethargy, weakness and fatigue when waking up.

Makes dreams more vivid and emotionally rich.

Adapts the body to rapid changes in time zones, reduces stress reactions, and regulates neuroendocrine functions.

Adapts the body of weather-sensitive people to changes in weather conditions. Shows immunostimulating and antioxidant properties.

Inhibits the secretion of gonadotropins, and to a lesser extent, other hormones of the adenohypophysis (corticotropin, thyroid-stimulating hormone, somatotropic hormone). Does not cause addiction or dependence.

When taken orally, it is quickly and completely absorbed and easily passes histohematic barriers, including the blood-brain barrier. Has a short half-life.

Special instructions

During the period of use of the drug Melarena®, it is recommended to avoid exposure to bright light.

It is necessary to inform women who want to become pregnant that the drug has a weak contraceptive effect.

Impact on the ability to drive vehicles and machinery

During the treatment period, care must be taken when driving vehicles and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Melatonin

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 0.3 mg dosage:

Hypromellose 62.50%,

Triethyl citrate 12.50%,

Titanium dioxide 25.00% – 3.00 mg;

For 3 mg dosage

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.

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, breastfeeding period; age under 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, swelling (usually in the first week of use).

Interaction

Incompatible with monoamine oxidase inhibitors (MAOIs), glucocorticosteroids, cyclosporine.

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

Concomitant use with non-steroidal anti-inflammatory drugs (NSAIDs) is not recommended.

It is not recommended to take together with hormonal medications.

Overdose

There are no data on cases of melatonin overdose.

There may be an increase in dose-dependent adverse reactions.

Treatment: gastric lavage, symptomatic therapy.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

2 years. Do not use the drug after the expiration date indicated on the package.

Manufacturer

Hemofarm LLC, Russia