MELATONIN POLSKI LEK

Package leaflet: Information for the patient

Melatonina Polski Lek, 5 mg, tablets
Melatoninum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, contact your doctor.

Table of contents

1. What Melatonina Polski Lek is and what it is used for
2. Important information before taking Melatonina Polski Lek
3. How to take Melatonina Polski Lek
4. Possible side effects
5. How to store Melatonina Polski Lek
6. Contents of the pack and other information

1. What Melatonina Polski Lek 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 a 24-hour period. Melatonina Polski Lek is a synthetically produced equivalent of the natural hormone.
Melatonina Polski Lek is used as an adjunctive treatment in:

• Sleep disorders associated with disturbances of the sleep-wake rhythm, such as sleep disorders related to changes in time zones (jet lag) or resulting from shift work,
• Circadian rhythm sleep-wake disorders in blind patients.

2. Important information before using Melatonina Polski Lek

When not to use Melatonina Polski Lek:

• if the patient is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6),
• after consumption of alcohol,
• during pregnancy or breastfeeding.

Warnings and precautions
Before starting treatment with Melatonina Polski Lek, consult a doctor if the patient has:

• liver function disorders,
• depression,
• immune system disorders,
• hormonal disorders,
• epilepsy,
• kidney function disorders.

Melatonina Polski Lek and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Fluvoxamine and medicines metabolized in the liver such as: citalopram, omeprazole, lanzoprazole increase blood concentration of melatonin administered simultaneously.
Other medicines that may affect melatonin's action: 5- or 8- methoxypsoralen (used in psoriasis treatment), cimetidine (used in peptic ulcer disease), estrogens (contraceptives and hormone replacement therapy), thioridazine (used in treatment of psychiatric disorders), imipramine (used in treatment of depression), sleeping pills and sedatives such as benzodiazepines and non-benzodiazepines (e.g. zaleplon, zolpidem, zopiclone), carbamazepine (antiepileptic drug), rifampicin (antibiotic), quinolones (bactericidal drugs belonging to chemotherapeutics group), anticoagulants.
Smoking may reduce melatonin blood concentration.
Melatonina Polski Lek and alcohol
Do not consume alcohol while taking Melatonina Polski Lek.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient data, Melatonina Polski Lek must not be used during pregnancy or breastfeeding.
Driving and operating machinery
Do not drive or operate machinery, as drowsiness may occur after taking the medicine, leading to reduced concentration.
Melatonina Polski Lek contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Melatonina Polski Lek

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Melatonina Polski Lek should be taken orally.
Adults:
Dosage of Melatonina Polski Lek:
In sleep disorders associated with 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.
In circadian rhythm sleep-wake disorders, e.g. associated with shift work: 1 mg to 5 mg once daily, taken one hour before bedtime.
In circadian rhythm sleep-wake disorders in blind individuals: take 0.5 mg to 5 mg once daily around 9:00 p.m. to 10:00 p.m.
This dosage also applies to long-term treatment.
The effect of the medicine in long-term treatment of circadian rhythm sleep-wake disorders may sometimes only become apparent after 2 weeks of treatment.
If a lower dose of melatonin than 5 mg is required, another medicinal product should be used. Melatonina Polski Lek should only be used when efficacy has not been achieved with other available melatonin products containing lower doses.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Most frequently observed:
Nervous system disorders: asthenia, headache, confusion (disorientation), sedation, decreased body temperature;
Less frequently:
Increased number of epileptic seizures in children with central nervous system damage and epilepsy.
Cardiac disorders: tachycardia;
Skin and subcutaneous tissue disorders: itching, rash, urticaria, eruption;
Endocrine disorders: gynaecomastia.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 Polski Lek

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and on each blister
after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

What Melatonina Polski Lek contains

• The active substance is melatonin. One tablet contains 5 mg of melatonin.
• The other ingredients (excipients) are: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, magnesium stearate.

What Melatonina Polski Lek looks like and contents of the pack
Melatonina Polski Lek is a white to cream, round tablet, 6.8 – 7.3 mm in diameter, convex on both sides, without spots or chipping.
Melatonina Polski Lek tablets are packed in PVC/PVDC/Aluminium blisters containing 10 tablets per blister. Pack sizes: 10 tablets (1 blister), 20 tablets (2 blisters), 30 tablets (3 blisters), 60 tablets (6 blisters), 90 tablets (9 blisters). The blisters with the patient leaflet are packed into a cardboard box.
Marketing Authorisation Holder:
"Polski Lek - Dystrybucja" Sp. z o.o.
ul. Chopina 10
34-100 Wadowice
Poland
e-mail: [email protected]
Manufacturer:
Grand Medical Poland Sp. z o.o.
ul. M. Faradaya 2
03-233 Warszawa
Poland