Milarena^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

N05CH01 (Melatonin)

Active Substance

Melatonin (BP British Pharmacopoeia)

Dosage Forms

	Milarena®	Film-coated tablets, 0.3 mg: 30 pcs.
		Film-coated tablets, 3 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to almost white, round, biconvex; the core is from white to almost white.

Excipients: calcium hydrogen phosphate dihydrate – 67.37 mg, microcrystalline cellulose – 25 mg, croscarmellose sodium – 2 mg, povidone K25 – 3.33 mg, colloidal silicon dioxide – 0.5 mg, talc – 1 mg, calcium stearate – 0.5 mg.

Shell composition (hypromellose – 62.5%, triethyl citrate – 12.5%, titanium dioxide – 25%) – 3 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets from white to blue, round, biconvex; the core is from white to almost white.

Excipients: calcium hydrogen phosphate dihydrate – 64.67 mg, microcrystalline cellulose – 25 mg, croscarmellose sodium – 2 mg, povidone K25 – 3.33 mg, colloidal silicon dioxide – 0.5 mg, talc – 1 mg, calcium stearate – 0.5 mg.

Shell composition (hypromellose – 62.5%, macrogol 400 – 12.5%, titanium dioxide – 24.21%, aluminum lake FD&C Blue No.2 (12-14%) – 0.28%, aluminum lake FD&C Blue No.1 (11-13%) – 0.48%, quinoline yellow lake – 0.02%, iron oxide black dye – 0.01%) – 3 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Clinical-Pharmacological Group

Adaptogenic agent

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; melatonin receptor agonists

Pharmacological Action

Synthetic analogue of the pineal gland hormone melatonin; has adaptogenic, sedative, and hypnotic effects. 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, positively affects the intellectual and mnestic functions of the brain, and the emotional and personal sphere. Promotes the organization of biological rhythm and normalization of night sleep. Improves sleep quality, reduces the frequency of headaches, dizziness, improves mood. Accelerates falling asleep, reduces the number of nighttime awakenings, improves well-being after morning awakening, does not cause feelings of lethargy, weakness, and fatigue upon awakening. Makes dreams more vivid and emotionally rich.

Adapts the body to rapid time zone changes, reduces stress reactions, regulates neuroendocrine functions. Adapts the body of weather-sensitive people to changes in weather conditions. 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). Does not cause habituation or dependence.

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed, easily passes through histohematic barriers, including the BBB. Has a short T_1/2.

Indications

Tablets 0.3 mg

Prevention and course treatment

• Desynchronosis (disturbance of the normal circadian rhythm): due to rapid movement between Earth’s time zones; in case of light regime disturbance, including in people engaged in shift or rotational work;
• Weather sensitivity;
• Fatigue, sleep disorders (including in elderly patients);
• Depressive syndrome.

Tablets 3 mg

• Desynchronosis (disturbance of the normal circadian rhythm): due to rapid movement between Earth’s time zones; in case of light regime disturbance, including in people engaged in shift or rotational work;
• Sleep disorder.

ICD codes

Dosage Regimen

Orally.

Tablets 0.3 mg

1 tablet once a day 30-40 minutes before sleep. The duration of the treatment course is determined individually (from 6 to 8 weeks). Repeated courses are possible.

Tablets 3 mg

For sleep disorder, desynchronosis – 1 tablet once a day 30-40 minutes before sleep.

When used as an adaptogen for time zone changes – 1 day before the flight and on the following 2-5 days – 1 tablet 30-40 minutes before sleep.

Maximum daily dose – 6 mg.

Adverse Reactions

Possible allergic reactions to the components of the drug, headache, nausea, vomiting, diarrhea, morning sleepiness, edema (usually in the first week of administration).

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 the 3 mg dosage);
• Pregnancy;
• Breastfeeding period;
• Age under 18 years (efficacy and safety of use have not been established).

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and breastfeeding.

Special Precautions

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

It is necessary to inform women wishing to become pregnant about the drug’s weak contraceptive effect.

Effect on the ability to drive vehicles and mechanisms

During treatment, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

There are no data on cases of melatonin overdose. Enhancement of dose-dependent adverse reactions is possible.

Treatment: gastric lavage, symptomatic therapy.

Drug Interactions

Incompatible with MAO inhibitors, corticosteroids, cyclosporine.

Enhances the effect of drugs that depress the CNS, and beta-blockers.

Concomitant use with NSAIDs is not recommended.

Concomitant use with hormonal drugs is not recommended.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.