Description
Release form
Tablets.
Packing
In the package 24 pcs.
Pharmacological action
Melarithm ® – is a synthetic analogue of the hormone of the pineal gland (pineal gland).
Normalizes circadian rhythms.
Regulates the sleep-wake cycle.
Promotes the normalization of night sleep (speeds up falling asleep, improves sleep quality, reduces the number of night awakenings, improves well-being after morning awakening, does not cause a feeling of lethargy and fatigue when waking up).
Adapts the body to a quick change of time zones, reduces stress reactions.
It exhibits immunostimulating and pronounced antioxidant properties.
Contraindications
– hypersensitivity to the components of the drug
– autoimmune diseases
– liver failure
– severe renal failure
– children under 18 years of age.
Pregnancy and lactation
Pregnancy
Clinical data are not available on the effects of melatonin on pregnancy. Preclinical studies do not indicate adverse effects on pregnancy, fetal development, delivery process or postnatal development of newborns. Due to the lack of clinical data, the use of the drug Melarithm during pregnancy and women planning a pregnancy is not recommended.
Breastfeeding period
Due to this. Since endogenous melatonin is detected in breast milk, it is likely that exogenous melatonin can also pass into breast milk. Data from animals, including rodents, sheep, cattle, and primates, indicate transmission of melatonin through the placenta or milk from mother to fetus. Therefore, the use of the drug Melarithm during breastfeeding is not recommended.
Special instructions
Melarithm may cause drowsiness. Therefore, the drug should be used with caution if probable drowsiness may be associated with a risk or danger to the patient’s health.
Clinical data on the use of the drug Melarithm in patients with autoimmune diseases are not available, in this regard, the drug is not recommended for patients with autoimmune diseases.
There is only limited evidence on the safety of melatonin in patients with hepatic or renal failure, 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 in the drug.
Influence on the ability to drive vehicles and work with mechanisms
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Composition
Melatonin – 3 mg.
Excipients:
microcrystalline cellulose – 82.4 mg, croscarmellose sodium
(sodium starch glycolate) – 10.5 mg, calcium hydrogen phosphate
dihydrate – 82.4 mg, mannitol
– 44 mg,
macrogol 6000 mg (
macrogol, 6000 mg), stearate – 2.7 mg.
Shell composition:
opadray II (polyvinyl alcohol – 2.4 mg, titanium dioxide – 1.5 mg, macrogol – 1.212 mg, talc – 0.888 mg).
Dosage and administration
Inside, with plenty of water.
3-6 mg / day one hour before bedtime for 4-7 days.
For desynchronosis (abrupt change of time zones), 6 mg 1 hour before bedtime. followed by 3 mg for the first three days.
Renal failure
The effect of varying degrees of renal failure on the pharmacokinetics of melatonin has not been studied, so melatonin should be used with caution in such patients. Patients with severe renal failure are not recommended.
Hepatic insufficiency
There is no experience with melatonin in patients with impaired liver function. Published data indicate a marked increase in the concentration of endogenous melatonin in the daytime as a result of reduced clearance in such patients. Therefore, melatonin is not recommended for patients with impaired liver function.
Elderly
patients It is known that the metabolism of melatonin slows with age, however, due to the high interindividual variability of pharmacokinetic parameters, even within groups of the same gender, it is difficult to give recommendations on dose adjustment for elderly patients.
Side effects
Infectious and parasitic diseases: rarely – herpes zoster.
From the blood and lymphatic system: rarely – leukopenia, thrombocytopenia.
On the part of the immune system: frequency unknown – hypersensitivity reactions.
From the side of metabolism and nutrition: rarely – hypertriglyceridemia, hypokalemia. hyponatremia.
Mental disorders: infrequently – irritability, neurosis, anxiety, insomnia, unusual dreams, nightmares, anxiety rarely – mood changes, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, decreased mood, depression.
From the nervous system: infrequently – migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence rarely – fainting, memory impairment, impaired concentration, dream state, restless legs syndrome, poor quality of sleep. paresthesia.
From the side of the organ of vision: rarely – decreased visual acuity, blurred vision, increased lacrimation.
On the part of the organ of hearing and labyrinth disorders: rarely – vertigo, positional vertigo.
From the side of the heart: rarely – angina pectoris, feeling of palpitations.
From the vessels: infrequently – arterial hypertension rarely – hot flashes.
From 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 on the oral mucosa. ulcerative glossitis, vomiting, abnormal intestinal noise, bloating, hypersecretion of saliva, halitosis, abdominal discomfort, upset stomach, gastritis.
From the liver and biliary tract: infrequently – hyperbilirubinemia.
From the skin and subcutaneous tissues: infrequently – dermatitis, sweating at night, itching and generalized itching. rash, dry skin rarely – eczema, erythema, hand dermatitis, psoriasis, generalized rash, itchy rash, Nail damage frequency is unknown – Quincke edema, swelling of the mouth, swelling of the tongue.
From the side of musculoskeletal and connective tissue: infrequently – pain in the limb rarely – arthritis, muscle spasm, neck pain. night cramps.
From the kidneys and urinary tract: infrequently – glucosuria, rarely proteinuria – polyuria, hematuria, nocturia.
From the genitals and breast: 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 – deviations from the norm of laboratory parameters of liver function, weight gain rarely – increased activity of hepatic transaminases, deviation from the norm of the content of electrolytes in the blood, deviations from the norm of the results of laboratory tests.
If any of the adverse reactions listed in the instructions are exacerbated, or if you notice other adverse reactions not listed in the instructions, notify your doctor.
Storage conditions
The drug should be stored in a dry, dark place and out of the reach of children at a temperature not exceeding 25 ° C.
Expiration
2 years.
Prescription terms from
pharmacies Over-the-counter
Form of Treatment
tablets
