Melatonine noxarem 3 mg - jet lag treatment 10 tablets

Product Description

Treatment indicated in adults for the short-term treatment of jet lag.

Indications

Melatonin Noxarem is used for the short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by time differences when crossing different time zones (travelling east or west).

Composition

Active ingredients

3 mg: Each tablet contains 3 mg of melatonin.

5 mg: Each tablet contains 5 mg of melatonin.

Excipients

Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Pregelatinized starch.

Directions for use and Dosage

The standard dose is one 3 mg tablet per day, to be taken at the local time of the start of the night's sleep, starting from arrival at the destination and for a maximum of 4 days. A 5 mg tablet may be taken instead of a 3 mg tablet at the local time of the onset of bedtime if the standard 3 mg dose does not provide adequate symptom relief. The 5 mg tablet should not be taken in addition to the 3 mg tablet, but a higher dose may be taken on subsequent days. The maximum daily dose is 5 mg once daily. The dose that provides adequate symptom relief should be taken for the shortest possible period of time. Since taking melatonin at inappropriate times may have no effect or may cause an adverse effect on resynchronization following jet lag, melatonin should not be taken before 8:00 PM or after 4:00 AM (local time at the destination). Elderly: Since the pharmacokinetics of exogenous (immediate-release) melatonin are generally similar in young adults and elderly people, there are no specific dosage recommendations for the elderly. Renal impairment: Experience with the use of melatonin in patients with renal impairment is limited. Caution should be exercised when taking melatonin in patients with renal impairment. Melatonin is not recommended for patients with severe renal impairment. Hepatic impairment: There are no empirical data on the use of melatonin in patients with hepatic impairment. Limited data suggest that plasma clearance of melatonin is significantly reduced in patients with cirrhosis. Melatonin is not recommended for patients with hepatic impairment. Paediatric population: The safety and efficacy of melatonin in children and adolescents aged 0 to 18 years have not been established. No data are available.

Method of administration: Oral use.

Tablets should be swallowed with a glass of water. Consuming food at or near the time of melatonin intake should not affect the efficacy or safety of melatonin; however, it is recommended that you avoid food approximately 2 hours before and 2 hours after taking melatonin.

Warnings

Drowsiness

Melatonin may cause drowsiness. Therefore, the product should be used with caution if drowsiness could pose a safety risk.

Autoimmune diseases

There are no clinical data on the use of melatonin in subjects with autoimmune diseases. Therefore, the use of melatonin is not recommended in patients with autoimmune diseases.

Hepatic and renal impairment

Empirical data on the safety and efficacy of melatonin use in patients with hepatic or renal impairment are limited. Melatonin is not recommended for patients with hepatic impairment or severe renal impairment.

Cardiovascular conditions

Data on adverse events related to blood pressure and heart rate caused by melatonin in populations with cardiovascular conditions and concomitant treatment with antihypertensive drugs are limited. It is unclear whether these adverse effects are attributable to melatonin itself or to interactions between melatonin and other drugs. The use of melatonin is not recommended in patients with cardiovascular conditions and concomitant treatment with antihypertensive drugs.

Concomitant use of anticoagulants

Caution should be exercised when taking melatonin concomitantly with anticoagulant drugs, including warfarin and new direct-acting anticoagulants, as melatonin may enhance the effect of these drugs and cause an increased risk of bleeding.

Undesirable effects

Summary of the safety profile

The most frequently reported adverse effects when taking melatonin short-term for the treatment of jet lag are somnolence, headache, and dizziness/disorientation. Somnolence, headache, dizziness, and nausea are also the most frequently reported adverse effects. frequently when typical clinical doses of melatonin have been taken for periods of several days or weeks by healthy subjects and patients.

Tabulation of adverse reactions

The following adverse reactions to melatonin in general have been reported in clinical trials or spontaneous case reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Reporting of adverse reactions Suspected Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Overdose

Cases of daily doses of up to 300 mg of melatonin have been reported in the literature without clinically significant adverse reactions. In case of overdose, drowsiness is likely to occur. Clearance of the active substance occurs within 12 hours of ingestion. No special treatment is necessary.

Pregnancy and breastfeeding

Pregnancy

For melatonin, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal-foetal development, parturition or development. Postnatal. Exogenous melatonin readily crosses the human placenta. Due to the lack of clinical data, the use of the medicine is not recommended in women who are pregnant or intending to become pregnant.

Breastfeeding

Endogenous melatonin has been identified in human breast milk, so exogenous melatonin is probably excreted in breast milk. There are data from animal models, including rodents, sheep, cattle, and primates, demonstrating the passage of melatonin from the mother to the fetus through the placenta or milk. Therefore, melatonin should not be used during breastfeeding.

Fertility

There are no data available on the possible adverse effects of short-term use of melatonin on human fertility.

Format

10 tablets of 3 mg