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Mechanism of action

Synthetic analogue of the hormone of the pineal gland (pineal gland) melatonin; has an adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms. Increases the concentration of gamma-aminobutyric acid (GABA, 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.

It regulates the sleep-wake cycle, diurnal changes in locomotor activity and body temperature, and has a positive effect on the intellectual-mental functions of the brain, on the emotional-personal sphere. Contributes to the organization of biological rhythm and the normalization of night sleep. Improves the quality of sleep, reduces the frequency of attacks of headaches, dizziness, improves mood. Accelerates falling asleep, reduces the number of nightly awakenings, improves health after a morning awakening, does not cause a feeling of lethargy, weakness and fatigue upon awakening. Makes dreams more vivid and emotionally intense.

Adapts the body to the rapid change of time zones, reduces stress reactions, 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, to a lesser extent - other hormones of the adenohypophysis (corticotropin, thyroid stimulating hormone, somatotropic hormone). Not addictive and addictive.

Pharmacokinetics

When ingested, it is quickly and completely absorbed, histohematogenous barriers easily pass, including BBB. Has a short t1/2.

Indications

0.3 mg tablets

Prevention and course treatment:

- desynchronosis (disruption of the normal circadian rhythm): due to the rapid movement between the time zones of the Earth; in violation of the light mode, incl. for people engaged in shift or shift work;

- meteosensitivity;

- fatigue, sleep disorders (including in elderly patients);

- depressive syndrome.

3 mg tablets

- desynchronosis (disruption of the normal circadian rhythm): due to the rapid movement between the time zones of the Earth; in violation of the light mode, incl. for people engaged in shift or shift work;

- sleep disturbance.

Dosage and administration

Inside

0.3 mg tablets

1 pill 1 time / day for 30-40 minutes before bedtime. Duration of treatment is determined individually (from 6 to 8 weeks). Repeat courses are possible.

3 mg tablets

Atsleep disturbance, desynchronosis - 1 pill 1 time / day for 30-40 minutes before bedtime.

When appliedas an adaptogen when changing time zones - 1 day before the flight and for the next 2-5 days - 1 pill 30-40-40 minutes before sleep.

The maximum daily dose is 6 mg.

Side effect

Maybe: allergic reactions to the components of the drug, headache, nausea, vomiting, diarrhea, morning drowsiness, swelling (usually in the first week of admission).

Contraindications

- hypersensitivity to melatonin and other components of the drug;

- autoimmune diseases;

- allergic diseases;

- Hodgkin's disease, leukemia, lymphoma, myeloma;

- epilepsy;

- diabetes;

- chronic renal failure;

- severe renal dysfunction (for dosage of 0.3 mg);

- pregnancy;

- lactation period;

- age up to 18 years (efficacy and safety have not been established).

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Special notes

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

It is necessary to inform women who want to become pregnant about the presence of a weak contraceptive effect.

Influence on ability to drive vehicles and mechanisms

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

Overdosage

There are no data on cases of overdose of melatonin. Dose-dependent adverse reactions may increase.

Treatment: gastric lavage, symptomatic therapy.

Drug interaction

Incompatible with MAO inhibitors, corticosteroids, cyclosporine.

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

Not recommended simultaneous reception with NSAIDs.

Not recommended in conjunction with hormonal drugs.

Terms and conditions of storage

The drug should be stored out of the reach of children, dry, protected from light, at a temperature not exceeding 25 ° C.