Melarena 3mg tbl p / p about N30

Manufacturer: Штада
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Brief information

Производитель

Штада

Действующее вещество

Мелатонин
There are contraindications, specialist advice is required

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Film-coated tablets1 table.
active substance: 
melatonin0.3/3 mg
excipients: calcium hydrophosphate dihydrate-67.37/64.67 mg; MCC-25/25 mg; croscarmellose sodium-2/2 mg; povidone K25-3.33/3.33 mg; silicon dioxide colloidal-0.5/0.5 mg; talc-1/1 mg; calcium stearate-0.5/0.5 mg 
film shell (0.3 mg tablets): (hypromellose-62.5%, triethylcitrate-12.5%, titanium dioxide-25%) - 3 mg 
shell film (tablets 3 mg): (polymer — 62,5%, macrogol 400 — 12,5%, titanium dioxide — from 24,21%, aluminum lacquer FD&C blue 2 (12-14%) to 0.28%, aluminum lacquer FD&C blue 1 (11-13%) — 0.48%, the varnish quinoline yellow — a 0.02%, the colorant iron oxide black — 0,01%) — 3 mg 

Description of the dosage form

Round, biconvex tablets, covered with a film shell from white to almost white (for a dosage of 0.3 mg) or blue (for a dosage of 3 mg) color.

The core is white to almost white.

Pharmacokinetics

When ingestion rapidly and completely absorbed, easily passes gistogematicalkie barriers, including the blood-brain. Has a short T 1/2 .

Pharmacodynamics

A synthetic analogue of the pineal body hormone (epiphysis) melatonin; it has an adaptogenic, sedative, and hypnotic effect. Normalizes circadian rhythms.

Increases the concentration of GABA and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxalkinase, 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 to organize the biological rhythm and normalize night sleep. Improves the quality of sleep, accelerates falling asleep, reduces the number of night awakenings, improves health after waking up in the morning, does not cause a feeling of lethargy, fatigue and fatigue when waking up. Makes dreams more vivid and emotionally rich.

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. It exhibits immunostimulating and antioxidant properties. Inhibits the secretion of gonadotropins, to a lesser extent-other hormones of the adenohypophysis (corticotropin, TSH, STH). It is not addictive or addictive.

Indications of the drug

Film-coated tablets, 0.3 mg

Prevention and course treatment:

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

meteosensitivity;

fatigue, sleep disorders (including in elderly patients);

depressive syndrome.

Film-coated tablets, 3 mg

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

sleep disturbance.

Contraindications

hypersensitivity to melatonin and other components of the drug;

autoimmune diseases, allergic diseases;

lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, chronic kidney failure;

severe renal impairment (for a dosage of 3 mg);

pregnancy;

breast feeding;

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

Use during pregnancy and lactation

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

Dosage and administration

Inside.

Film-coated tablets, 0.3 mg

1 table./day 30-40 minutes before bedtime. The duration of treatment is determined individually (from 6 to 8 weeks). Repeated courses are possible.

Film-coated tablets, 3 mg

In case of sleep disturbance, desynchronosis-1 table./day 30-40 minutes before bedtime.

When used as an adaptogen when changing time zones-1 day before the flight and in the next 2-5 days-3 mg for 30-40 minutes before sleep.

The maximum daily dose is 6 mg.

Side effect

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

Interaction

Incompatible with MAO inhibitors, corticosteroids, cyclosporine. Increases the effect of drugs that depress the Central nervous system, and beta-blockers. Simultaneous administration with NSAIDs is not recommended.

It is not recommended in conjunction with hormonal drugs.

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.

Special instruction

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

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

Influence on the ability to drive vehicles, mechanisms. During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release

Film-coated tablets, 0.3 mg, 3 mg. 10 table. in contour cell packaging made of PVC film laminated with ACLAR material, and aluminum printed lacquered foil or aluminum printed lacquered foil and aluminum foil laminated with PVC and polyamide film. 1 or 3 contour cell packages in a pack of cardboard.

Conditions of supply of pharmacies

Without a prescription.

Manufacturer

MAKIZ-PHARMA LLC. 109029, Russia, Moscow, Avtomobilny PR., 6, p. 5.

Address of the place of production: 109029, Moscow, Automobile Ave., 6, p. 4, 6, 8.

or chemopharm LLC. 62, Kievskoe shosse, Obninsk, Kaluga region, Russia, 249030.

Name and address of the legal entity in whose name the registration certificate was issued/organization accepting claims: JSC NIZHFARM. 7, Salganskaya str., Nizhny Novgorod, 603950, Russia.

Tel.: (831) 278-80-88; Fax: (831) 430-72-28.

e-mail: med@stada.ru

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

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