Melason pills 3mg №10×3

NameMelason tabl. The main active ingredient Melatonin Release form Tablets Dosage 3 mg Published data indicate a marked increase in endogenous melatonin levels during the daytime as a result of reduced clearance in these patients. Therefore, melatonin is not recommended for use in patients with hepatic impairment. Use in patients with impaired renal function: There are no studies on the effect of varying degrees of renal insufficiency on the pharmacokinetics of melatonin, therefore melatonin should be used with caution in patients with impaired renal function. Use in pediatric practice: The safety and efficacy of Melason in children aged 0 to 18 years has not been established. Indications for use Sleep disturbance, including chronic insomnia, especially in patients over 55 years of age; a disorder of the normal circadian rhythm associated with the change of time zones, manifested by increased fatigue. Dosage and administration For sleep disorders: 1 tablet 30-40 minutes before bed once a day. The duration of taking the drug is determined by the doctor, but should not exceed 13 weeks. When changing time zones: 1 day before the flight and in the next 2-5 days, 1 tablet 30-40 minutes before bedtime. The maximum daily dose is up to 2 tablets per day. Use during pregnancy and lactation During pregnancy and lactation, the use is contraindicated. The ability to influence the reaction rate when driving vehicles or working with other mechanisms During the period of treatment, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions. The drug may cause drowsiness. Therefore, the drug should be used with caution if the effects of drowsiness are likely to be associated with a safety risk. Melason has a moderate effect on the ability to drive a car and other mechanisms. Precautions It is necessary to inform women who want to become pregnant that the drug has a weak contraceptive effect. Avoid bright lighting. Due to the lack of clinical data, Melason is not recommended for use in patients with autoimmune diseases. Melason contains lactose. Patients with rare hereditary galactose intolerance, lactose deficiency or glucose-galactose malabsorption (LAPP) should not take this medicine. Interaction with other drugs Enhances the effect of drugs that depress the central nervous system and beta-blockers. It is not recommended to take together with hormonal drugs. Incompatible with MAO inhibitors, glucocorticosteroids and cyclosporine. Pharmacokinetic interactions: There is a large amount of data in the literature on the effect on endogenous melatonin production of the following substances: agonists / antagonists of opioid and adrenergic receptors, prostaglandin inhibitors, antidepressants, benzodiazepines, tryptophan and ethanol. Whether these substances affect the dynamics or kinetic effects of melatonin or vice versa has not been studied. It is known that at concentrations significantly higher than therapeutic, melatonin induces CYP3A in vitro. The clinical significance of this fact has not been fully elucidated. In case of development of signs of induction, consideration should be given to reducing the dose of concomitantly used drugs. At concentrations significantly higher than therapeutic, melatonin does not induce CYP1A enzymes in vitro. Therefore, the interaction of melatonin with other active substances due to the effect of melatonin on isoenzymes of the CYP1A group can hardly be significant. Melatonin metabolism is mediated by CYP1A enzymes. Therefore, the possibility of interaction of melatonin with other active substances due to their influence on the enzymes of the CYP1A group is likely. Caution should be exercised in patients taking fluvokeamine, which increases the concentration of melatonin (17-fold increase in AUC and 12-fold increase in Cmax in the blood) due to inhibition of its metabolism by cytochrome P450 (CYP) isoenzymes – CYP1A2 and CYP2C19. This combination should be avoided. Caution should be exercised in patients taking 5- or 8-methoxyproralen, which increases the concentration of melatonin due to inhibition of its metabolism. Caution should be exercised in patients taking cimetidine (a CYP2D inhibitor), which increases plasma melatonin levels by inhibiting its metabolism. Smoking can reduce melatonin levels by stimulating CYP1A2. Caution should be exercised in patients taking estrogens, which are able to increase the concentration of melatonin by inhibiting its metabolism by CYP1A1 and CYP1A2 isoenzymes. CYP1A2 inhibitors such as chylones are able to increase melatonin exposure. CYP1A2 inducers, such as carbamazepine and rifampicin, can reduce melatonin plasma levels. Pharmacodynamic Interactions: Melatonin enhances the sedative effects of benzodiazepine and non-benzodiazepine hypnotics such as zaleplon, zolpidem, and zopiclone. In a clinical study, evidence of a pharmacodynamic interaction between melatonin and zolpidem was observed one hour after co-administration. Co-administration resulted in increased deterioration in attention, memory and coordination compared with zolpidem. In studies, melatonin was administered together with thioridazine and imipramine, active substances that affect the central nervous system. No clinically significant pharmacokinetic interaction was observed in any of the cases. However, co-administration with melatonin resulted in increased feelings of calmness and difficulty performing certain tasks compared with imipramine alone, as well as an increase in the feeling of haziness in the head compared with thioridazine alone. While taking the drug, you should not drink alcohol, as it reduces the effectiveness of the drug. Contraindications Hypersensitivity to the active substance or auxiliary components of the drug, severe renal dysfunction, autoimmune diseases, leukemia, lymphoma. Lymphogranulomatosis, myeloma, epilepsy, diabetes mellitus, chronic renal failure, pregnancy and lactation. Composition Composition per tablet active substance: melatonin 3 mg; excipients: microcrystalline cellulose, corn starch, magnesium stearate, lactose monohydrate. Overdose No cases of drug overdose have been noted. There are literature data on the use in a daily dose of up to 300 mg without clinically significant side effects. In case of an overdose, the development of drowsiness is expected. Clearance of the active substance is expected within 12 hours after ingestion. Possible increased severity of side effects. In case of accidental overdose: gastric lavage, symptomatic therapy. Side effects Side effects are presented below and classified according to the organ system and frequency of development. The frequency of development is defined as follows: very frequent: >1/10; frequent: >1/100 – <1/10; infrequent: >1/1000 – <1/100; rare: >1/10000 – <1/1000; very rare - <1/10000, the frequency is unknown (cannot be established based on the available data). Infections and invasions: rarely - herpes zoster. From the circulatory and lymphatic system: rarely - leukopenia, thrombocytopenia. Immune system disorders: frequency unknown - hypersensitivity. Metabolic disorders: rarely - hypertriglyceridemia, hypocalcemia, hyponatremia. From the side of the cardiovascular system: rarely - angina pectoris, palpitations; infrequently - hypertension; rarely - "hot flashes" (periodic reddening of the skin of the face). From the digestive system: infrequently - abdominal pain, constipation, dry mouth, dyspepsia, mouth ulcers, nausea; rarely - gastroesophageal reflux, indigestion, vomiting, increased intestinal motility, flatulence, hyperfunction of the salivary gland, bad breath, gastritis, inflammation of the oral mucosa, ulcers on the tongue. From the skin and subcutaneous tissue: infrequently - hyperhidrosis; rarely - eczema, erythema, itchy rash and itching, dry skin, nail damage, night sweats, dermatitis; unknown - angioedema, swelling of the oral cavity, swelling of the tongue. Mental disorders: infrequently - irritability, nervousness, restlessness, insomnia, pathological dreams, nightmares, anxiety; rarely - mood variability, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased libido, depressed mood, depression. Disorders from the nervous system: infrequently - migraine, lethargy, psychomotor hyperactivity, dizziness, drowsiness; rarely - fainting, memory impairment, impaired concentration, daydreaming, restless legs syndrome, poor sleep quality, paresthesia. On the part 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 - dizziness when changing body position. From the musculoskeletal system: infrequently - pain in the extremities, rarely - arthritis, muscle spasms, neck pain, night cramps. From the side of the kidneys and urinary system: infrequently - glucosuria, proteinuria; rarely - polyuria, hematuria, nocturia. From the reproductive system and mammary glands: infrequently - symptoms of menopause; rarely - priapism, prostatitis; frequency unknown - galactorrhea. Laboratory indicators: infrequently - hyperbilirubinemia, changes in laboratory parameters of liver function; rarely - an increase in the activity of "liver enzymes", a change in the concentration of electrolytes, a change in other laboratory tests. Other: infrequently - asthenia, chest pain; rarely - fatigue, pain, thirst. Storage conditionstext Buy Melason tablets 3mg No. 10x3