Package leaflet: Information for the user

Melasolaren 5 mg, tablets
Melatoninum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient information leaflet or as
directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Melasolaren is and what it is used for
Important information before taking Melasolaren
How to take Melasolaren
Possible side effects
How to store Melasolaren
Contents of the pack and other information

1. What Melasolaren 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. Melasolaren is a synthetic equivalent of this natural hormone.
Melasolaren 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 shift work,
Circadian rhythm sleep-wake disorders in blind patients.

2. Important information before using Melasolaren

When not to use Melasolaren:

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

Warnings and precautions
Before starting to use Melasolaren, consult a doctor if the patient has:

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

Melasolaren and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Fluvoxamine and drugs metabolized in the liver such as citalopram, omeprazole, and lanzoprazole may increase blood levels of concurrently administered melatonin.
Other medicines that may affect melatonin's action include: 5- or 8-methoxypsoralen (used in psoriasis treatment), cimetidine (used in peptic ulcer treatment), estrogens (contraceptives and hormone replacement therapy), thioridazine (used in psychiatric disorders), imipramine (used in depression treatment), sleeping and sedative medicines such as benzodiazepines and non-benzodiazepines (e.g. zaleplon, zolpidem, zopiclone), carbamazepine (an antiepileptic), rifampicin (an antibiotic), quinolones (bactericidal agents among chemotherapeutics), and anticoagulants.
Smoking may reduce melatonin blood levels.

Melasolaren and alcohol
Alcohol should not be consumed during treatment with Melasolaren.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient data, Melasolaren must not be used during pregnancy or breastfeeding.

Driving and operating machinery
Patients should not drive or operate machinery, as drowsiness after taking the medicine may reduce concentration.

Melasolaren 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 Melasolaren

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Melasolaren should be taken orally.
Adults:
Dosage of Melasolaren:
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 consecutive 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: take 0.5 mg to 5 mg once daily at approximately 9:00–10:00 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. Melasolaren should only be used when the effectiveness of other available melatonin products with lower doses has not been demonstrated.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine 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 observed: Increased frequency of epileptic seizures in children with central nervous system disorders and epilepsy.

Cardiac disorders: tachycardia.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, eruption.

Endocrine disorders: gynecomastia.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a 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
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 Melasolaren

Keep this medicine out of the sight and reach of children.
No special storage conditions 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 should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the packaging and other information

What Melasolaren 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 Melasolaren looks like and contents of the pack

Melasolaren is a round tablet, 6.8 – 7.3 mm in diameter, white to cream in colour, biconvex, without spots or crumbling.

Melasolaren tablets are packed in PVC/PVDC/Aluminium blisters with 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). Blisters with the patient leaflet are packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
SOLARPHARMA Sp. z o.o.
Krucza Street 63
05-120 Legionowo
Poland
e-mail: [email protected]

Manufacturer:
Grand Medical Poland Sp. z o.o.
M. Faradaya Street 2
03-233 Warsaw
Poland