Melarena Tablets p / o 3 mg, # 10

Round, biconvex film-coated tablets from white to almost white (for a dosage of 0.3 mg) or blue (for a dosage of 3 mg).

The kernel is white to almost white.

Pharmaco-therapeutic group

N4 Tablets of 0.3 mg Prevention and course of treatment: Desynchronosis (violation of the normal circadian rhythm) due to rapid movement between the time zones of the Earth

in case of violation of the light regime, including for people engaged in shift or shift work.

Meteosensitivity.

Fatigue, sleep disturbances (including in elderly patients).

Depressive syndrome.

3 mg tablets Desynchronosis (violation of the normal circadian rhythm) due to rapid movement between the time zones of the Earth

in case of violation of the light regime, including for people engaged in shift or shift work.

Sleep disturbances.

Application during pregnancy and during breastfeeding

The drug is contraindicated for use during pregnancy and during breastfeeding.

Dosage form

Film-coated tablets, 0.3 mg, 3 mg.

10 tablets in a blister strip made of polyvinyl chloride film laminated with AklarВ®, and printed aluminum foil varnished or aluminum printed foil varnished and aluminum foil laminated with polyvinyl chloride and polyamide film.

1 or 3 blisters together with instructions for use in a cardboard box.

Shelf life

2 years.

Do not use the drug after the expiry date indicated on the package.

Name ENG

MILARENA

Clinical and pharmacological group

Adaptogenic drug

ATX code

Melatonin

Dosage

3mg

Structure

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 a dosage of 0.3 mg (hypromellose 62.50%, triethyl citrate 12.50%, titanium dioxide 25.00%)?

3.00 mg

for a dosage of 3 mg (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.

INN / Active ingredient

Melatonin

Storage conditions and periods

In a dry, dark place at a temperature not exceeding 25 В° C. Keep out of the reach of children.

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

Specifications

Category

Sedatives

,

Antipsychotics

,

Neurological disorders

Scope of the medicinal product

Vitamins

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

ten

Minimum age from

18 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Makiz-Pharma

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Adaptogenic agent

Anatomical and therapeutic characteristics

N05CH01 Melatonin

Dosage form

Film-coated tablets

Packaging

Box

The target audience

Adult

Expiration date in days

730

Dosage (volume) of the substance in the preparation

1 tab.

melatonin 0.3 mg

Package weight, g

35

Mode of application

:

Inside. 0.3 mg tablets 1 tablet once a day 30-40 minutes before bedtime. The duration of the course of treatment is determined individually (from 6 to 8 weeks). Repeated courses are possible. 3 mg tablets For sleep disturbances, desynchronosis - 1 tablet once a day 30-40 minutes before bedtime. When used as an adaptogen for jet lag? 1 day before the flight and in the next 2-5 days? 1 tablet 30-40 minutes before bedtime. The maximum daily dose is 6 mg. Elderly patients Melatonin metabolism decreases with age, which should be taken into account when choosing a dosage regimen for elderly patients. Taking this into account, in elderly patients, it is possible to take the drug 60-90 minutes before bedtime. Renal failure The effect of varying degrees of renal failure on the pharmacokinetics of melatonin has not been studied.therefore, melatonin should be used with caution in these patients. The use of the drug is not recommended for patients with severe renal impairment. Hepatic impairment There is no experience with melatonin in patients with impaired liver function. In patients with impaired liver function, significantly increased plasma concentrations of endogenous melatonin were observed during the daytime. The use of the drug is not recommended for patients with hepatic impairment.The use of the drug is not recommended for patients with hepatic impairment.The use of the drug is not recommended for patients with hepatic impairment.

Information on technical characteristics, delivery set, country of manufacture