Melarhythm tabs 3mg #12

Melarhythm instruction

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Composition

Melatonin - 3 mg.
Excipients: microcrystalline cellulose - 82.4 mg, croscarmellose sodium (sodium starch glycolate) - 10.5 mg, calcium phosphate dihydrate - 82.4 mg, mannitol - 44 mg, macrogol 6000 (polyethylene glycol 6000) - 15 mg, magnesium stearate - 2.7 mg.
The composition of the shell: opadry II (polyvinyl alcohol - 2.4 mg, titanium dioxide - 1.5 mg, macrogol - 1.212 mg, talc - 0.888 mg).
Packaging - In packing of 12 pieces.

pharmachologic effect

Melarhythm - is a synthetic analogue of the hormone of the pineal gland (epiphysis). Normalizes circadian rhythms. Regulates the sleep-wake cycle. It contributes to the normalization of night sleep (speeds up sleep, improves the quality of sleep, reduces the number of night awakenings, improves health after a morning awakening, does not cause a feeling of lethargy and weakness on waking). Adapts the body to the rapid change of time zones, reduces stress reactions. Shows immunostimulating and pronounced antioxidant properties.

Melarhythm, indications for use

- sleep disorders, incl. caused by the disturbance of the rhythm "sleep-wakefulness", such as desynchronosis (abrupt change of time zones).

Contraindications

- hypersensitivity to Melarhythm;
- autoimmune diseases;
- liver failure;
- severe renal failure;
- children's age up to 18 years.

Dosage and administration

Inside, drinking plenty of water.
At 3-6 mg / day for an hour before sleep for 4-7 days.
With desynchronosis (abrupt change of time zones), 6 mg 1 hour before sleep. followed by 3 mg in the first three days.

Renal failure

The effect of varying degrees of renal failure on melatonin pharmacokinetics has not been studied, so melatonin should be used with caution in such patients. In patients with severe renal insufficiency, the use of the drug is not recommended.

Liver failure

There is no experience with melatonin in patients with impaired liver function. Published data indicate a marked increase in the concentration of endogenous melatonin during daytime hours as a result of reduced clearance in these patients. Therefore, melatonin is not recommended for patients with impaired liver function.

Elderly patients

It is known that melatonin metabolism slows down with age, but due to the high interindividual variability of pharmacokinetic parameters, even within groups with the same gender, it is difficult to advise on the dose adjustment for elderly patients.

Use during pregnancy and lactation

Pregnancy

There are no clinical data on the effects of melatonin on the course of pregnancy. These preclinical studies do not indicate an adverse effect on the course of pregnancy, fetal development, the delivery process or postnatal development of newborns. Due to the lack of clinical data, the use of the drug Melarhythm during pregnancy and women planning pregnancy is not recommended.

Breastfeeding period

For the reason that. that endogenous melatonin is detected in breast milk, it is likely that exogenous melatonin can also penetrate into breast milk. Data obtained for animals, including rodents, sheep, cattle and primates, indicate the transfer of melatonin through the placenta or milk from mother to fetus. Therefore, the use of the drug Melarhythm during breastfeeding is not recommended.

Side effects

Infectious and parasitic diseases: rarely - herpes zoster.
From the side of blood and lymphatic system: rarely - leukopenia, thrombocytopenia.
On the part of the immune system: the frequency is unknown - hypersensitivity reactions.
Metabolism and nutrition: rarely - hypertriglyceridemia, hypokalemia. hyponatremia.
Mental disorders: infrequently - irritability, neurosis, anxiety, insomnia, unusual dreams, nightmares, anxiety; rarely - mood swings, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, depressed mood, depression.
Nervous system disorders: infrequently - migraine, headache, lethargy, psychomotor hyperactivity, dizziness, drowsiness; rarely - fainting, impaired memory, impaired concentration, dreaming, restless legs syndrome, poor quality of sleep. paresthesias.
On the part of the organ of vision: rarely - reduced visual acuity, blurred vision, increased tearing.
On the part of the organ of hearing and labyrinth disorders: rarely - vertigo, positional vertigo.
From the side of the heart: rarely - exertional angina, palpitations.
From the side of vessels: infrequently - arterial hypertension; rarely - "tides".
On the part of the gastrointestinal tract: infrequently - abdominal pain, abdominal pain in the upper abdomen, dyspepsia, ulcerative stomatitis, dry mouth, nausea; rarely, gastroesophageal reflux disease, gastrointestinal disturbance or disorder, blistering of the oral mucosa. ulcerative glossitis, vomiting, abnormal intestinal noise, abdominal distension, hypersecretion of saliva, bad breath, abdominal discomfort, indigestion, gastritis.
On the part of the liver and biliary tract: infrequently - hyperbilirubinemia.
On the part of the skin and subcutaneous tissues: infrequently - dermatitis, night sweats, itching and generalized itching. rash, dry skin; rarely - eczema, erythema, dermatitis of the hands, psoriasis, generalized rash, itchy rash, nail damage; frequency is unknown - angioedema, swelling of the mouth, swelling of the tongue.
From the musculoskeletal and connective tissues: infrequently - pain in the limb; rarely - arthritis, muscle spasm, neck pain. night cramps.
On the part of the kidneys and urinary tract: infrequently - glycosuria, proteinuria; rarely - polyuria, hematuria, nocturia.
On the part of the genitals and the mammary gland: infrequently - menopausal symptoms; rarely - priapism, prostatitis; frequency unknown galactorrhea.
General disorders and disorders at the injection site: infrequently - asthenia, chest pain; rarely - fatigue, pain, thirst.
Laboratory and instrumental data: infrequently - abnormal laboratory parameters of liver function, weight gain; rarely, increased activity of liver transaminases, abnormal electrolyte levels in the blood, abnormal laboratory test results.
If any of the adverse reactions indicated in the instructions become worse, or you notice other adverse reactions not indicated in the instructions, inform your doctor.

special instructions

The drug Melarhythm may cause drowsiness. Therefore, the drug should be used with caution, if the likely drowsiness may be associated with a risk or danger to the patient's health.
Clinical data on the use of the drug Melarhythm in patients with autoimmune diseases are absent, therefore, Melarhythm is not recommended to be prescribed to patients with autoimmune diseases.
There is only limited data on the safety of melatonin in patients with hepatic or renal insufficiency; therefore, melatonin is not recommended for use in patients with severe renal and hepatic insufficiency.
It is recommended to avoid bright lighting.
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 work with mechanisms
During the period of treatment, it is necessary to refrain from driving and practicing potentially hazardous activities that require increased concentration and psychomotor speed.
Shelf life - 2 years.

Storage conditions

Melarhythm should be stored in a dry, dark place and out of reach of children at a temperature not exceeding 25 ° C.

Terms of sell

You can buy Melarhythm without a prescription.