Melatonina Lek-am

PATIENT INFORMATION LEAFLET: USER INFORMATION

Melatonin LEK-AM, 1 mg, tablets

Melatonin LEK-AM, 3 mg, tablets

Melatonin LEK-AM, 5 mg, tablets

(Melatoninum)

Read the entire leaflet carefully, as it contains important information for the patient.

This medicine is available without a prescription, so that some conditions can be treated without the help of a doctor.
However, to achieve good treatment results, the medicine should be used with caution.

• This leaflet should be kept, so that it can be read again if necessary.
• A doctor or pharmacist should be consulted if advice or additional information is needed.
• If symptoms worsen or do not improve, a doctor should be contacted.
• If any of the side effects worsen or if any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.

Table of contents of the leaflet:

• 1. What is Melatonin LEK-AM and what is it used for
• 2. Important information before using Melatonin LEK-AM
• 3. How to use Melatonin LEK-AM
• 4. Possible side effects
• 5. How to store Melatonin LEK-AM
• 6. Other information

1. What is Melatonin LEK-AM and what is it used for

Melatonin is a hormone that occurs naturally in the human body, produced in the central nervous system by the pineal gland. This hormone plays an important role in regulating sleep and wakefulness during the day. Melatonin LEK-AM is a synthetically produced equivalent of the natural hormone.
Melatonin LEK-AM is used as a supportive treatment in:

• sleep disorders related to sleep-wake rhythm disorders, e.g. sleep disorders related to time zone changes or shift work,
• disorders of the daily sleep-wake rhythm in blind patients.

2. Important information before using Melatonin LEK-AM

When not to use Melatonin LEK-AM

• after consuming alcohol,
• during pregnancy or breastfeeding.

When to exercise special caution when using Melatonin LEK-AM:

Before starting to use Melatonin LEK-AM, a doctor should be consulted if the patient has:
liver function disorders, depression, immune system function disorders, hormonal disorders, epilepsy, or kidney function disorders.

Using Melatonin LEK-AM with other medicines:

Fluvoxamine and drugs that undergo hepatic metabolism, such as citalopram, omeprazole, and lansoprazole, increase the blood concentration of melatonin administered at the same time.
Other medicines that may affect the action of melatonin: 5- or 8-methoxypsoralen (used in the treatment of psoriasis), cimetidine (in the treatment of peptic ulcer disease), estrogens (contraceptives and hormone replacement therapy), thioridazine (used in the treatment of psychiatric problems), imipramine (used in the treatment of depression), sleeping pills and sedatives, e.g. benzodiazepines.
The doctor should be informed about all medicines taken recently, including those available without a prescription.

Using Melatonin LEK-AM with food and drink

During the use of Melatonin LEK-AM, alcohol should not be consumed.
Pregnancy and breastfeeding
Due to the lack of sufficient data, Melatonin LEK-AM should not be used during pregnancy and breastfeeding.

Driving and operating machinery:

Vehicles and machinery should not be operated, as the medicine may cause drowsiness leading to decreased concentration.

3. How to use Melatonin LEK-AM

The medicine should be taken orally.

Adults:

Dosage of Melatonin LEK-AM:

In sleep disorders related to time zone changes:
2 mg to 3 mg of melatonin once a day after dark, starting from the first day of travel. The treatment should be continued for 2-3 days after the end of the trip.
In sleep-wake rhythm disorders related to shift work: 1 mg to 5 mg per day, one hour before bedtime.
In sleep-wake rhythm disorders in blind patients, 0.5 mg to 5 mg should be taken once a day around 9-10 pm.
This dosage also applies to long-term use of the medicine.
The effect of the medicine is observed gradually, often after 2 weeks of taking the medicine.

4. Possible side effects

Like all medicines, Melatonin LEK-AM can cause side effects, although they do not occur in everyone.
The most common ones are:
Nervous system disorders: asthenia, headaches, confusion (disorientation), sedation, decreased body temperature;
Less common:
Increased number of seizures in children with central nervous system damage and epilepsy;
Heart disorders: tachycardia;
Skin and subcutaneous tissue disorders: itching, rash, urticaria, eruption.
Endocrine disorders: gynecomastia.
If any of the side effects worsen or if any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
phone: 22 49 21 301
fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Melatonin LEK-AM

The medicine should be stored at a temperature below 25°C, out of the reach of children.
Melatonin LEK-AM should not be used after the expiry date stated on the packaging.

6. Other information

What Melatonin LEK-AM contains:

1 tablet of Melatonin LEK-AM contains the active substance: 1 mg, 3 mg, or 5 mg of melatonin and the excipients: microcrystalline cellulose 102, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

What Melatonin LEK-AM looks like and what the pack contains:

The 1 mg and 3 mg tablets are white, round, and flat on both sides.
The 5 mg tablets are white, round, and convex on both sides, with a dividing line on one side.
The tablets are packaged in a polyethylene container with a lid or in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, placed in a cardboard box.
1 mg: 90 tablets
3 mg: 14 tablets; 60 tablets
5 mg (in a container): 30 tablets; 60 tablets
5 mg (in blisters): 15 tablets; 30 tablets; 60 tablets; 90 tablets

Marketing authorization holder and manufacturer:

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone number: 22 785-27-60

Date of leaflet approval:

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