Melarithm tablets 3mg, No. 30

• As a sleeping pill.

• As an adaptogen for the normalization of biological rhythms.

Inside. For adults, 1.5-3 mg 30-40 minutes before bedtime, once a day. As an adaptogen when changing time zones: 1 day before the flight and in the next 2-5 days, 3 mg 30-40 minutes before bedtime. The maximum daily dose is up to 6 mg per day.

active substance: melatonin - 3 mg;

excipients: microcrystalline cellulose - 82.4 mg, sodium carboxymethyl starch (sodium starch glycolate) - 10.5 mg, calcium hydrogen phosphate dihydrate - 82.4 mg, mannitol - 44 mg, macrogol 6000 (polyethylene glycol 6000) - 15 mg, magnesium stearate - 2.7 mg;

excipients for the shell: Opadray II [polyvinyl alcohol - 2.4 mg, titanium dioxide - 1.5 mg, macrogol - 1.212 mg, talc - 0.888 mg].

• Hypersensitivity

• severe renal dysfunction,

• autoimmune diseases,

• leukemia,

• lymphoma,

• allergic reactions,

• lymphogranulomatosis,

• myeloma,

• epilepsy,

• diabetes,

• chronic renal failure,

• pregnancy and breastfeeding period.

Dosage form: film-coated tablets

Composition

1 film-coated tablet contains:

active substance: melatonin 1.5 mg / 3 mg;

excipients: microcrystalline cellulose 41.2 mg / 82.4 mg, sodium carboxymethyl starch (sodium starch glycolate) 5.25 mg / 10.5 mg, calcium hydrogen phosphate dihydrate 41.2 mg / 82.4 mg, mannitol 22 mg / 44 mg, macrogol 6000 (polyethylene glycol 6000) 7.5 mg / 15 mg, magnesium stearate 1.35 mg / 2.7 mg;

excipients for the shell: Opadray II [polyvinyl alcohol 1.2 mg / 2.4 mg, titanium dioxide 0.75 mg / 1.5 mg, macrogol 0.606 mg / 1.212 mg, talc 0.444 mg / 0.888 mg].

Description

Round biconvex film-coated tablets of white or almost white color.

Pharmacotherapeutic group

Adaptogenic agent

ATX code : N05CH01

Pharmacological properties

Pharmacodynamics

It is a synthetic analogue of the pineal gland hormone (pineal gland). Normalizes circadian rhythms. Regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature. Promotes the normalization of night sleep (accelerates falling asleep, improves sleep quality, reduces the number of night awakenings, improves well-being after waking up in the morning, does not cause feelings of lethargy, weakness and fatigue upon waking, dreams become more vivid and emotionally saturated).

Adapts the body to the rapid change of time zones, reduces stress reactions.

Shows immunostimulating and pronounced antioxidant properties.

Inhibits the secretion of gonadotropins, to a lesser extent - other hormones of the adenohypophysis - corticotropin, thyrotropin and growth hormone.

It is not addictive and addictive.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed, it easily passes histohematogenous barriers, including the blood-brain barrier. Has a short half-life.

Indications for use

• As a sleeping pill.

• As an adaptogen for the normalization of biological rhythms.

Contraindications

• Hypersensitivity

• severe renal dysfunction,

• autoimmune diseases,

• leukemia,

• lymphoma,

• allergic reactions,

• lymphogranulomatosis,

• myeloma,

• epilepsy,

• diabetes,

• chronic renal failure,

• pregnancy and breastfeeding period.

Application during pregnancy and during breastfeeding

The use of melatonin is contraindicated during pregnancy and during breastfeeding.

Method of administration and dosage

Inside. Adults 1.5-3 mg 30-40 minutes before bedtime, once a day.
As an adaptogen when changing time zones : 1 day before the flight and in the next 2-5 days, 3 mg 30-40 minutes before bedtime. The maximum daily dose is up to 6 mg per day.

Side effect

From the immune system: allergic reactions.
From the side of the central nervous system: headache, morning sleepiness.
From the digestive system: nausea, vomiting, diarrhea.
Other: swelling in the first week of admission.

Overdose

Symptoms Strengthening the severity of side effects.
Treatment. Gastric lavage, symptomatic therapy.

Interaction with other medicinal products

Melatonin enhances the effect of drugs that depress the central nervous system and beta-blockers.

It is not recommended to take melatonin in conjunction with hormonal drugs.

Melatonin is incompatible with monoamine oxidase (MAO) inhibitors, glucocorticosteroids, icyclosporin.

special instructions

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

It is necessary to inform women wishing to become pregnant that the drug has a weak contraceptive effect.

Influence on the ability to drive vehicles and mechanisms

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

Release form

Film-coated tablets, 1.5 mg, 3 mg.

On 6, 10, 12, 20, 24 tablets in a blister strip from a film of polyvinyl chloride and printed aluminum foil varnished.

1, 2, 4 blister packs of 6 tablets each with instructions for use in a cardboard box.

1, 2 blister packs of 10 tablets each with instructions for use in a carton box.

1, 2 blister packs of 12 tablets each with instructions for use in a carton box.

1 blister strip of 20 tablets, together with instructions for use, in a pack of cardboard.

1 blister strip of 24 tablets together with instructions for use in a pack of cardboard.

Storage conditions

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

Shelf life

2 years. Do not use after the expiration date printed on the package.

Vacation conditions

Without recipe.