Melatonin biofarm

Package leaflet: Information for the patient

Melatonina Biofarm, 2 mg, tablets
Melatonina Biofarm, 3 mg, tablets
Melatonina Biofarm, 5 mg, tablets
Melatoninum
Please read this leaflet carefully 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
your doctor or pharmacist.

• Keep this leaflet, as 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents:

1. What Melatonina Biofarm is and what it is used for
2. Important information before taking Melatonina Biofarm
3. How to take Melatonina Biofarm
4. Possible side effects
5. How to store Melatonina Biofarm
6. Other information

1. What Melatonina Biofarm is and what it is used for

Melatonin is a naturally occurring hormone in the human body, produced in the central nervous system by the pineal gland. This hormone plays an important role in regulating the sleep-wake cycle over 24 hours. Melatonina Biofarm is a synthetically produced equivalent of the natural hormone.
Melatonina Biofarm is used for the short-term treatment of:

• sleep disorders related to disturbances in the sleep-wake cycle, such as sleep disorders associated with jet lag or shift work,
• circadian rhythm sleep-wake disorders in blind patients.

2. Important information before taking Melatonina Biofarm

When not to take Melatonina Biofarm

• if you are allergic to melatonin or any of the other ingredients of Melatonina Biofarm (listed in section 6),
• after alcohol consumption,
• during pregnancy or breastfeeding.

When to exercise special caution with Melatonina Biofarm
Before starting treatment with Melatonina Biofarm, consult your doctor if you have:
liver function disorders, depression, immune system disorders, hormonal disorders, epilepsy, or kidney function disorders.
Cigarette smoking may reduce melatonin levels.

Taking Melatonina Biofarm with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Fluvoxamine and drugs metabolized in the liver such as: citalopram, omeprazole, lanzoprazole may increase blood levels of melatonin when taken concomitantly.
• Other medicines that may affect melatonin action:
• 5- or 8-methoxypsoralen (used in psoriasis treatment),
• cimetidine (used in peptic ulcer disease),
• estrogens (contraceptives and hormone replacement therapy),
• thioridazine (used to treat psychiatric disorders),
• imipramine (used to treat depression),
• quinolones and rifampicin (used to treat bacterial infections),
• carbamazepine (used to treat epilepsy),
• sedatives, e.g. benzodiazepines,
• benzodiazepine derivatives and other hypnotics (such as zaleplon, zolpidem and zopiclone).

Children and adolescents
Do not use this medicine in children and adolescents aged 0 to 18 years, as it has not been studied in this patient group and its effects are unknown.

Taking Melatonina Biofarm with alcohol
Do not consume alcohol while taking Melatonina Biofarm.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Melatonina Biofarm is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
After taking this medicine, do not drive or operate machinery, as drowsiness may occur, leading to reduced concentration.

This medicine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is considered "sodium-free".

3. How to use Melatonina Biofarm

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The tablet should be swallowed with water.
The lowest effective dose of melatonin should be used. If necessary, another melatonin-containing medicine allowing for a different (e.g. lower) dose should be considered.

Adults
Dosage of Melatonina Biofarm:
In 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.
In circadian rhythm sleep-wake disorders, e.g. related to shift work:
1 mg to 5 mg once daily, one hour before bedtime.
In circadian rhythm sleep-wake disorders in blind individuals:
0.5 mg to 5 mg once daily at approximately 9:00–10:00 p.m.
The duration of treatment in circadian rhythm sleep-wake disorders in blind individuals should be discussed with a doctor.
The therapeutic effect in long-term treatment of circadian rhythm sleep-wake disorders may sometimes become apparent only after 2 weeks of treatment.

Patients with hepatic impairment
Melatonina Biofarm should not be used in patients with impaired liver function.

Patients with renal impairment
Melatonina Biofarm should not be used in patients with impaired kidney function.

Elderly patients
Dose adjustment is not necessary in elderly patients.

Accidental overdose of Melatonina Biofarm
If an excessive dose is accidentally taken, contact your doctor or pharmacist immediately.
Taking more than the recommended daily dose may in individual cases cause drowsiness, disorientation, or the occurrence of psychosis.

Missed dose of Melatonina Biofarm
Do not take a double dose to make up for a missed dose.

Discontinuation of Melatonina Biofarm
There are no known harmful effects associated with stopping or ending treatment early. No withdrawal symptoms have been observed after discontinuation of Melatonina Biofarm.

If you have any further questions about 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 will experience them.
If the patient experiences any of the following severe adverse reactions, a doctor should be contacted immediately and use of this medicine should be discontinued:

Frequency unknown (cannot be estimated from the available data):

• hypersensitivity reaction (e.g., severe skin reactions, difficulty breathing);
• swelling of the face, lips or tongue, which may cause difficulty swallowing or breathing; if such symptoms occur, contact a doctor immediately.

Other possible adverse reactions are listed below.

Uncommon (may occur in not more than 1 in 100 people):

• irritability, nervousness, restlessness, insomnia, unusual dreams, nightmares, anxiety,
• migraine, headache, lethargy (tiredness, lack of energy), psychomotor agitation, dizziness, somnolence,
• hypertension,
• abdominal pain, epigastric pain, dyspepsia, oral ulceration, dry mouth, nausea,
• increased blood bilirubin levels,
• skin inflammation, night sweats, pruritus, rash, generalized itching, dry skin,
• limb pain,
• glycosuria, proteinuria,
• menopausal symptoms,
• weakness, chest pain, decreased body temperature,
• abnormal liver function test results, weight gain.

Rare (may occur in not more than 1 in 1000 people):

• increased frequency of epileptic seizures in children with central nervous system disorders and epilepsy,
• urticaria, exanthema, erythema, hand dermatitis, psoriasis, generalized rash, itchy rash, nail plate abnormalities,
• breast enlargement in men (gynaecomastia),
• herpes zoster,
• decreased white blood cell count, decreased platelet count,
• increased blood triglyceride levels, decreased blood calcium levels, decreased blood sodium levels,
• mood changes, aggression, agitation, crying, tension symptoms, disorientation, early morning awakening, increased libido (increased sexual drive), depressed mood, depression,
• fainting, memory impairment, concentration difficulties, dream-like state, restless legs syndrome, poor sleep quality, tingling or numbness,
• blurred vision, visual disturbances, excessive tearing,
• dizziness upon positional change, balance disorders,
• angina pectoris, palpitations, tachycardia,
• hot flushes,
• gastroesophageal reflux disease, gastrointestinal disturbances, oral mucosal blisters, tongue ulceration, stomach upset, vomiting, abnormal intestinal peristalsis sounds, bloating, excessive salivation, bad breath, abdominal discomfort, gastric disturbances, gastritis,
• joint inflammation, muscle cramps, neck pain, nocturnal cramps,
• polyuria, haematuria, nocturnal enuresis,
• prolonged, painful erection (priapism), prostatitis,
• feeling of fatigue, pain, thirst,
• increased liver enzyme activity, abnormal blood electrolyte levels, abnormal laboratory test results.

Frequency unknown (cannot be estimated from the available data):

• galactorrhea

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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 Warszawa
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 this medicine.

5. How to store Melatonina Biofarm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
No special temperature storage conditions apply to this medicine.
Medicines must 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 package and other information

What Melatonina Biofarm contains
Melatonina Biofarm, 2 mg, tablets
One tablet contains 2 mg of melatonin (Melatoninum).
Melatonina Biofarm, 3 mg, tablets
One tablet contains 3 mg of melatonin (Melatoninum).
Melatonina Biofarm, 5 mg, tablets
One tablet contains 5 mg of melatonin (Melatoninum).
Excipients: microcrystalline cellulose type 102, microcrystalline cellulose type 101, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

What Melatonina Biofarm looks like and contents of the pack
Melatonina Biofarm, 2 mg
Round, white or almost white, biconvex tablets, with a circular embossing on one side, 7.0 mm ± 0.3 mm in diameter.
Melatonina Biofarm, 3 mg
Round, white or almost white, biconvex tablets, 7.0 mm ± 0.3 mm in diameter.
Melatonina Biofarm, 5 mg
Round, white or almost white, biconvex tablets, with a single-scored line on one side, 9.0 mm ± 0.3 mm in diameter.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Melatonina Biofarm, 2 mg, tablets: 20, 30, 60, 90 tablets
Melatonina Biofarm, 3 mg, tablets: 10, 20, 30, 60, 90 tablets
Melatonina Biofarm, 5 mg, tablets: 30, 60, 90 tablets

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]