Welson 3 mg, 30 pcs.

Pharmproekt, Russia

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$15
Welson 3 mg, 30 pcs.
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Product Overview

Composition

One film-coated tablet contains:
 
Active substance :
 
 melatonin - 3 mg.
 
Excipients:
 
calcium hydrogen phosphate dihydrate - 64.67 mg,
 
microcrystalline cellulose - 25.00 mg,
 
povidone K 25 - 3.33 mg,
 
croscarmellose sodium - 2.00 mg,
 
talcum powder - 1.00 mg,
 
colloidal silicon dioxide - 0.50 mg,
 
calcium stearate - 0.50 mg.
 
Shell composition :
 
white opadra (03A280002) - 3.00 mg [hypromellose (hydroxypropyl methylcellulose) - 40%, microcrystalline cellulose - 32%, titanium dioxide - 20%, macrogol (polyethylene glycol) - 8%].

pharmachologic effect

A synthetic analogue of the hormone of the pineal gland (pineal gland); It has adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms.
 
It increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxalkinase, which is involved in the synthesis of GABA, dopamine and serotonin.
 
It regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature, positively affects the intellectual-mnestic functions of the brain, and on the emotional-personal sphere.
 
 
Promotes the organization of biological rhythm and the normalization of night sleep. Improves the quality of sleep, accelerates falling asleep, regulates neuroendocrine functions. Adapts the body of weather-sensitive people to changes in weather conditions.

Indications

In case of sleep disorder, including caused by a disturbance in the rhythm of "sleep-wakefulness", such as desynchronosis (a sharp change in time zones).

Contraindications

  • hypersensitivity to the components of the drug;
  • autoimmune diseases;
  • liver failure;
  • severe renal failure;
  • pregnancy and lactation;
  • age up to 18 years (the effectiveness and safety of the drug has not been established).
Carefully

The drug Welson® should be used with caution in patients with varying degrees of renal failure.

Side effects

Classification of adverse reactions by organs and systems with an indication of the frequency of their occurrence: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely ( ≥1 / 10000, <1/1000), very rarely (<1/10000), incl. individual messages, frequency is unknown (frequency cannot be estimated based on available data).
 
Infectious and parasitic diseases: rarely - herpes zoster.
 
Disorders from the blood and lymphatic system: rarely - leukopenia, thrombocytopenia.
 
Disorders from the immune system: frequency unknown - hypersensitivity reactions.
 
Metabolic and nutritional disorders: rarely - hypertriglyceridemia, hypokalemia, hyponatremia.
 
Mental disorders: infrequently - irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety; rarely - mood changes, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, decreased mood, depression.
 
Disorders from the nervous system: infrequently - migraine, headache, lethargy, psychomotor hyperactivity, dizziness, drowsiness; rare - fainting, memory impairment, impaired concentration, delirium, restless legs syndrome, poor quality of sleep, paresthesia.
 
Violations of the organ of vision: rarely - decreased visual acuity, blurred vision, increased lacrimation.
 
Hearing disorders and labyrinth disorders: rarely - vertigo, positional vertigo.
 
Disturbances from the side of the heart: rarely - angina pectoris, palpitations.
 
Violations of the vessels: infrequently - arterial hypertension; rarely - "tides."
 
Disorders of the gastrointestinal tract: infrequently - abdominal pain, abdominal pain in the upper abdomen, dyspepsia, ulcerative stomatitis, dry mouth, nausea; rarely, gastroesophageal disease, gastrointestinal disturbance or upset, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, bloating, hypersecretion of saliva, halitosis, abdominal discomfort, gastric dyskinesia, gastritis.
 
Violations of the liver and biliary tract: infrequently - hyperbilirubinemia.
 
Disorders from the skin and subcutaneous tissues: infrequently - dermatitis, sweating at night, itching and generalized itching, rash, dry skin; rarely - eczema, erythema, dermatitis of the hands, psoriasis, generalized rash, itchy rash, nail damage; the frequency is unknown - Quincke's edema, swelling of the oral mucosa, swelling of the tongue.
 
Violations of the musculoskeletal and connective tissue: infrequently - pain in the limbs; rarely - arthritis, muscle spasm, neck pain, night cramps.
 
Disorders from the kidneys and urinary tract: infrequently - glucosuria, proteinuria; rarely - polyuria, hematuria, nocturia.
 
Disorders from the genitals and mammary glands: 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.
 
Influence on the results of laboratory and instrumental studies: infrequently - a deviation from the norm of laboratory indicators of liver function, an increase in body weight; rarely - an increase in the activity of “liver” transaminases, a deviation from the norm of the content of electrolytes in the blood, a deviation from the norm of the results of laboratory tests.
 
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Interaction

Pharmacokinetic interaction


It is known that in concentrations significantly higher than therapeutic, melatonin induces the CYP3A isoenzyme in vitro. The clinical significance of this phenomenon is not fully understood. If signs of induction develop, consideration should be given to reducing the dose of the drugs used simultaneously.

At concentrations significantly higher than therapeutic, melatonin does not induce isoenzymes of the CYP1A group in vitro. Therefore, the interaction of melatonin with other drugs due to the effect of melatonin on isoenzymes of the CYP1A group is apparently insignificant.

Melatonin metabolism is mainly mediated by CYP1A isoenzymes. Therefore, the interaction of melatonin with other drugs is possible due to the effect of melatonin on isoenzymes of the CYP1A group.

Caution should be exercised in patients taking fluvoxamine, which increases the concentration of melatonin (increase in AUC by 17 times and Cmax by 12 times) due to inhibition of its metabolism by isoenzymes of cytochrome P450 (CYP): CYP1A2 and CYP2C19. This combination should be avoided.

Caution should be exercised in patients taking 5- and 8-methoxy-psoralen, which increases the concentration of melatonin due to inhibition of its metabolism.

Caution should be exercised in patients taking cimetidine (an inhibitor of CYP2D isoenzymes), since it increases the plasma melatonin content by inhibiting the latter.

Smoking can reduce the concentration of melatonin due to the induction of the CYP1A2 isoenzyme.

Caution should be exercised in relation to patients taking estrogens (for example, contraceptives or hormone replacement therapy) who increase the concentration of melatonin by inhibiting their metabolism by the isoenzymes CYP1A1 and CYP1A2.

Inhibitors of CYPA2 isoenzymes, for example, quinolones, are able to increase the exposure of melatonin.

Inducers of the CYP1A2 isoenzyme, such as carbamazepine and rifampicin, are able to lower the plasma concentration of melatonin. 
There is a lot of data in the modern literature regarding the effect of adrenergic and opioid receptor agonists / antagonists, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol on the secretion of endogenous melatonin. Studies of the mutual influence of these drugs on the dynamics or kinetics of melatonin have not been conducted.

Pharmacodynamic interaction


While taking melatonin, you should not drink alcohol, as it reduces the effectiveness of the drug.

Melatonin potentiates the sedative effect of benzodiazepine and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. In a clinical study, there were clear signs of a transient pharmacodynamic interaction between melatonin and zolpidem an hour after they were taken. The combined use can lead to a progressive disorder of attention, memory and coordination compared with zolpidem monotherapy.

During the studies, melatonin was prescribed in conjunction with thioridazine and imipramine, drugs that affect the central nervous system. None of the cases revealed a clinically significant pharmacokinetic interaction. However, concomitant use with melatonin led to an increase in the feeling of calm and difficulty in performing certain tasks in comparison with monotherapy with imipramine, as well as to an increase in the feeling of “clouding in the head”, in comparison with monotherapy with thioridazine.

How to take, course of administration and dosage

Inside, drinking plenty of fluids.
 
In case of sleep disturbance: 3 mg once a day 30-40 minutes before bedtime.
 
With desynchronosis 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 6 mg.
 
Elderly patients
 
With age, there is a decrease in the metabolism of melatonin, which must be considered when choosing a dosage regimen for elderly patients. With this in mind, in elderly patients, it is possible to take the drug 60-90 minutes before bedtime.

Patients with impaired renal function
 
The effect of varying degrees of renal failure on the pharmacokinetics of melatonin has not been studied, so melatonin should be taken with caution in such patients. Patients with severe renal failure are not recommended.

Overdose

According to available literature data, the use of melatonin in a daily dose of up to 300 mg did not cause clinically significant adverse reactions. Hyperemia, abdominal cramps, diarrhea, headache and scotoma were observed with melatonin at doses of 3000-6600 mg for several weeks. When using very high doses of melatonin (up to 1 g), involuntary loss of consciousness was observed.
 
Symptoms: with an overdose, drowsiness may develop.

Treatment: gastric lavage, activated charcoal, symptomatic therapy. The clearance of the active substance is expected within 12 hours after ingestion.

Special instructions

During the period of use of the drug Welson®, it is recommended to avoid exposure to bright light.
 
It is necessary to inform women who want to become pregnant about the presence of a weak contraceptive effect in the drug.
 
There is no clinical data on the use of melatonin in patients with autoimmune diseases, and therefore, the use of this category of patients is not recommended.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.
 
Keep out of the reach of children.

Shelf life

4 years. 

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