Melatosim 5

Melatosim 5 mg Tablets

• Purpose: A dietary supplement supporting the management of insomnia.
• Dosage Form: Tablet.
• Packaging: 30 tablets (3 blisters of 10 tablets) with an informational leaflet in a cardboard box.

Active Ingredients

• Melatonin: 5 mg per tablet.

Other Ingredients:

• Microcrystalline cellulose
• Croscarmellose sodium
• Calcium carbonate
• Magnesium stearate
• Silicon dioxide
• Stearic acid

Indications

Assists in regulating sleep cycles and alleviating insomnia.

Dosage and Administration

• Adults: Take one tablet 30 minutes before bedtime, or as directed by a physician or pharmacist.
• For use longer than two months, consult your doctor.

Precautions and Contraindications

• Not recommended during pregnancy or lactation.
• Avoid use in children under 12 years of age without prior consultation with a healthcare provider.
• Use with caution if taking any medications, supplements, or herbal products, or if you have any medical conditions.
• Discontinue use and consult a healthcare provider if adverse effects occur.
• Avoid activities requiring alertness (e.g., driving, operating machinery) for 4-5 hours after consumption.
• This product is a supplement and not intended to diagnose, treat, cure, or prevent any disease.

Adverse Effects

Although typically well-tolerated, melatonin may cause the following in some individuals:

• Headache
• Dizziness
• Nausea
• Drowsiness
• Mild skin rash
• Abdominal discomfort

If any adverse effects occur, discontinue use and consult your physician or pharmacist.

Drug Interactions

Melatonin may interact with the following:

• Anticoagulants and antiplatelet agents (e.g., warfarin, heparin, clopidogrel, aspirin, NSAIDs) – may enhance anticoagulant effects.
• Anticonvulsants – may reduce their efficacy.
• Antihypertensives – may potentiate blood pressure-lowering effects.
• Benzodiazepines and alcohol – may amplify sedative effects.
• Immunosuppressants (e.g., azathioprine, cyclosporine, prednisone, daclizumab) – may interfere with their efficacy due to melatonin’s immunostimulatory effects.

Avoid concurrent use without medical supervision.

Pharmacological Effects and Mechanism of Action

Melatonin is a hormone produced by the pineal gland that plays a crucial role in regulating the body’s biological clock, endocrine secretions, and sleep patterns.

• Synthesis and Release: Stimulated by darkness and inhibited by light.
• Age-Related Decline: Decreased melatonin production with age may contribute to insomnia in the elderly.
• Circadian Rhythm: Sudden changes in sleep-wake cycles (e.g., jet lag, shift work) can disrupt melatonin production, leading to sleep disturbances.
• Supplemental Use: Oral melatonin supplements act as a natural sleep aid and circadian rhythm regulator, particularly for individuals with disrupted sleep patterns (e.g., travelers, shift workers).

Pregnancy and Lactation

There is insufficient reliable data on the safety of melatonin use during pregnancy and lactation. Avoid use in these periods.

Storage Conditions

• Store below 30°C, away from light, moisture, and heat sources.
• Keep out of reach of children and pets.