Melaxen Balance (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

N05CH01 (Melatonin)

Active Substance

Melatonin (BP British Pharmacopoeia)

Dosage Form

Melaxen Balance

Film-coated tablets, 0.3 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

15 pcs. – blister packs (4) – cardboard boxes.
15 pcs. – blister packs (2) – cardboard boxes.
30 pcs. – polyethylene bottles (1) – cardboard boxes.
60 pcs. – polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug used for temporary adaptation disorders

Pharmacotherapeutic Group

Adaptogenic agent

Pharmacological Action

It is a synthetic analogue of the pineal gland hormone. It is synthesized from amino acids of plant origin. It normalizes biological rhythms and has an adaptogenic, sedative, and hypnotic effect.

It adapts the body to rapid changes in time zones, normalizes seasonal and daily biorhythms, preventing the development of desynchronosis during changes in the light regime. It adapts the body of weather-sensitive people to changes in weather conditions. It regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature.

It helps to normalize night sleep (accelerates falling asleep, improves sleep quality, reduces the number of nighttime awakenings, improves well-being after morning awakening, does not cause feelings of lethargy, weakness, and fatigue upon awakening, dreams become brighter and more emotionally intense). It has a positive effect on the intellectual and mnestic functions of the brain and the emotional and personal sphere. It reduces stress reactions.

It 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. It exhibits immunostimulating and antioxidant properties. It has protective properties against free radical damage to DNA and proteins, inhibits lipid peroxidation processes.

It helps stimulate the production of interleukins and γ-interferon by lymphocytes. It helps slow down the processes of pathological changes in cells and is involved in the regulation of antitumor immunity. Due to its rhythm-regulating, immunomodulatory, and antioxidant effects, it can slow down the processes of cell aging. It inhibits the secretion of gonadotropin, and to a lesser extent, other hormones of the adenohypophysis – corticotropin, TSH, and GH.

The secretion of melatonin is subject to the circadian rhythm, which determines the rhythmicity of gonadotropic effects and sexual functions. The synthesis and secretion of melatonin depend on illumination – an excess of light inhibits its formation, while a decrease in illumination increases the synthesis and secretion of the hormone. A low dosage of melatonin is advisable for a long course of administration. It does not cause habituation or dependence.

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed, easily passes through histohematic barriers, including the blood-brain barrier. It has a short T_1/2.

Indications

Prevention and course treatment

• Desynchronosis (disturbance of the normal circadian rhythm): due to rapid movement between Earth’s time zones; in case of disruption of the light regime, incl. in people engaged in shift or rotational work; in case of disruption of biological rhythms in elderly people (age-related desynchronosis), against the background of somatic diseases (arterial hypertension);
• Weather sensitivity;
• Fatigue;
• Sleep disorders (incl. in elderly patients);
• Depressive syndrome.

ICD codes

Dosage Regimen

Take orally.

For adults, take 1 tablet once daily, 30-40 minutes before bedtime.

Administer the drug long-term; the recommended course duration is 6 to 8 weeks.

For course therapy, repeat administration 2 to 3 times per year for 6-8 weeks, typically in spring and autumn.

Swallow the tablet whole with a sufficient amount of water.

Do not exceed the prescribed dosage.

For jet lag prevention, initiate treatment on the day of travel and continue for several days after reaching the destination.

For shift work sleep disorders, take before daytime sleep.

Consult a physician for use beyond 8 weeks.

Adverse Reactions

Possible allergic reactions to the components of the drug, headache, nausea, vomiting, diarrhea, morning drowsiness, edema.

Contraindications

• Allergic diseases;
• Autoimmune diseases;
• Lymphogranulomatosis;
• Leukemia;
• Lymphoma;
• Myeloma;
• Epilepsy;
• Diabetes mellitus;
• Chronic renal failure (CRF);
• Pregnancy;
• Lactation period;
• Childhood (due to lack of data);
• Hypersensitivity.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation.

Women wishing to become pregnant should be informed about the weak contraceptive effect of the drug.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Contraindicated in children.

Geriatric Use

Prescribed according to indications.

Special Precautions

Avoid bright lighting.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Treatment gastric lavage, symptomatic therapy.

Drug Interactions

It enhances the effect of drugs that depress the CNS and beta-blockers.

It is not recommended to take it together with NSAIDs.

It is incompatible with MAO inhibitors, corticosteroids, and cyclosporine.

Storage Conditions

Store the drug at a temperature of 10°-30°C (50°-86°F), in a dry place, protected from light. Keep out of reach of children.

Shelf Life

The shelf life of the drug is 4 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by 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.