Melatonin lek-am
Poland
Table of Contents
Melatonin LEK-AM, 1 mg, tablets
Melatonin LEK-AM, 3 mg, tablets
Melatonin LEK-AM, 5 mg, tablets
(Melatoninum)
Please read this entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription so that certain conditions can be treated without the need for a doctor's visit.
However, to achieve effective treatment, the medicine should be used carefully.
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you need advice or additional information.
- If symptoms worsen or do not improve, contact your doctor.
- If any adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Leaflet contents:
- What Melatonin LEK-AM is and what it is used for
- Important information before taking Melatonin LEK-AM
- How to take Melatonin LEK-AM
- Possible side effects
- How to store Melatonin LEK-AM
- Other information
1. What Melatonin LEK-AM is and what it is used for
Melatonin is a hormone naturally produced in the human body by the pineal gland in the central nervous system. This hormone plays an important role in regulating the sleep-wake cycle over 24 hours. Melatonin LEK-AM is a synthetically produced equivalent of the natural hormone.
Melatonin LEK-AM is used as an adjunctive treatment in:
- Sleep disorders related to disturbances in the sleep-wake rhythm, such as sleep disorders associated with changes in time zones (jet lag) or shift work,
- Circadian rhythm sleep-wake disorders in blind patients.
2. Important information before using Melatonina LEK-AM
When not to use Melatonina LEK-AM
- if the patient is allergic to melatonin or any of the other ingredients of Melatonina LEK-AM,
- after consuming alcohol,
- during pregnancy or breastfeeding.
When to exercise special caution when using Melatonina LEK-AM:
Before starting treatment with Melatonina LEK-AM, consult a doctor if the patient has:
liver function disorders, depression, immune system disorders, hormonal disorders, epilepsy, or kidney function disorders.
Use of Melatonina LEK-AM with other medicines:
Fluvoxamine and drugs metabolized in the liver such as: citalopram, omeprazole, lanzoprazole, increase blood levels of melatonin when co-administered.
Other medicines that may affect melatonin's action: 5- or 8-methoxypsoralen (used in psoriasis treatment), cimetidine (used in peptic ulcer disease), estrogens (contraceptive agents and hormone replacement therapy), thioridazine (used in psychiatric disorders), imipramine (used in depression treatment), hypnotics and sedatives, e.g. benzodiazepines.
Inform your doctor about all medicines you have recently taken, including those available without a prescription.
Use of Melatonina LEK-AM with food and drink
Do not consume alcohol while using Melatonina LEK-AM.
Pregnancy and breastfeeding
Due to insufficient data, Melatonina LEK-AM should not be used during pregnancy or breastfeeding.
Driving and operating machinery:
Do not drive motor vehicles or operate machinery while using this medicine, as drowsiness may occur after taking it, leading to reduced concentration.
3. How to use Melatonina LEK-AM
The medicine should be taken orally.
Adults:
Dosage of Melatonina LEK-AM:
For sleep disorders related to time zone changes:
2 mg to 3 mg of melatonin once daily after sunset, starting on the first day of travel. Continue treatment for 2–3 days after completion of travel.
For circadian rhythm sleep-wake disorders, e.g. related to shift work: 1 mg to 5 mg once daily, one hour before bedtime.
For circadian rhythm sleep-wake disorders in blind individuals: 0.5 mg to 5 mg once daily at approximately 9:00–10:00 p.m.
This dosage also applies to long-term use of the medicine.
The effect of the medicine is observed gradually, often after 2 weeks of treatment.
4. Possible adverse reactions
Like all medicines, Melatonina LEK-AM can cause adverse reactions, although not everyone experiences them.
Most frequently observed:
Nervous system disorders: asthenia, headache, confusion (disorientation), sedation, decreased body temperature;
Less frequently:
Increased frequency of epileptic seizures in children with central nervous system damage and epilepsy;
Cardiac disorders: tachycardia;
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, eruption;
Endocrinological disorders: gynaecomastia.
If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Melatonina LEK-AM
Keep this medicine below 25°C, in a place inaccessible to children.
Do not use Melatonina LEK-AM after the expiry date stated on the packaging.
6. Other information
What Melatonina LEK-AM contains:
Each tablet of Melatonina LEK-AM contains the active substance: 1 mg, 3 mg, or 5 mg of melatonin,
and the following excipients: microcrystalline cellulose 102, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.
What Melatonina LEK-AM looks like and what the package contains:
1 mg and 3 mg tablets are white, round, flat on both sides.
5 mg tablets are white, round, biconvex, with a score line on one side.
The tablets are packed in polyethylene containers with screw caps or in PVC/PVDC/Aluminum blisters, or OPA/Aluminum/PVC/Aluminum blisters, placed in a cardboard box.
Pack sizes:
1 mg: 90 tablets
3 mg: 14 tablets; 60 tablets
5 mg (in container): 30 tablets; 60 tablets
5 mg (in blisters): 15 tablets; 30 tablets; 60 tablets; 90 tablets; 120 tablets
Marketing Authorisation Holder and Manufacturer:
LEK-AM Pharmaceutical Company Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Phone number: 22 785-27-60