Melatonina Biofarm

Package Leaflet: Information for the Patient

Melatonina Biofarm, 2 mg, tablets

Melatonina Biofarm, 3 mg, tablets

Melatonina Biofarm, 5 mg, tablets

Melatoninum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Melatonina Biofarm and what is it 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 is Melatonina Biofarm 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. Melatonina Biofarm is a synthetic equivalent of the natural hormone.
Melatonina Biofarm is used as a supportive treatment in:

• sleep disorders associated with sleep-wake rhythm disorders, e.g., sleep disorders associated with time zone changes or shift work,
• disorders of the daily sleep-wake rhythm 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 consuming alcohol,
• during pregnancy or breastfeeding.

When to exercise special caution when taking Melatonina Biofarm

Before starting treatment with Melatonina Biofarm, consult your doctor if you have:
liver function disorders, depression, immune system function disorders, hormonal disorders, epilepsy, or kidney function disorders.
Smoking may decrease melatonin levels.

Taking Melatonina Biofarm with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• Fluvoxamine and liver-metabolized drugs such as citalopram, omeprazole, and lansoprazole increase melatonin blood levels.
• Other medicines that may affect melatonin:
• 5- or 8-methoxypsoralen (used to treat psoriasis),
• cimetidine (used to treat stomach ulcers),
• estrogens (contraceptives and hormone replacement therapy),
• thioridazine (used to treat mental problems),
• 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 sleep-inducing medicines (such as zaleplon, zolpidem, and zopiclone).

Children and adolescents

Do not give this medicine to children and adolescents from 0 to 18 years old, as it has not been tested 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 or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Melatonina Biofarm is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

After taking the medicine, do not drive vehicles or operate machinery, as drowsiness may occur, leading to decreased concentration.

The medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

3. How to take Melatonina Biofarm

Always take this medicine exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Swallow the tablet with water.
Use the lowest effective dose of melatonin, and if necessary, use another melatonin medicine that allows for a different (e.g., lower) dose.

Adults

Dosing of Melatonina Biofarm:
In sleep disorders associated with time zone changes:
2 mg to 3 mg of melatonin once a day after dark, starting from the first day of travel. Continue treatment for 2-3 days after the end of the trip.
In sleep-wake rhythm disorders associated with shift work:
1 mg to 5 mg per day, 1 hour before bedtime.
In sleep-wake rhythm disorders in blind patients,
take 0.5 mg to 5 mg once a day around 9-10 pm.
The duration of treatment in sleep-wake rhythm disorders in blind patients should be consulted with a doctor.
The effect of the medicine in the treatment of long-term sleep-wake rhythm disorders may be observed after 2 weeks of treatment.

Patients with liver function disorders

Do not take the medicine if you have liver function disorders.

Patients with kidney function disorders

Do not take the medicine if you have kidney function disorders.

Elderly patients

Dose adjustment is not necessary in elderly patients.

Taking a higher dose of Melatonina Biofarm than recommended

In case of accidental overdose, contact your doctor or pharmacist as soon as possible. Taking a higher dose than recommended may, in individual cases, cause drowsiness, disorientation, or psychosis.

Missing a dose of Melatonina Biofarm

Do not take a double dose to make up for a missed dose.

Stopping treatment with Melatonina Biofarm

No harmful effects are known when stopping or ending treatment early. No withdrawal symptoms have been reported after stopping Melatonina Biofarm.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, tell your doctor immediately and stop taking this medicine:
Frequency not known(cannot be estimated from the available data):

• hypersensitivity reaction (e.g., severe skin reactions, breathing difficulties);
• facial, lip, or tongue swelling, which may cause difficulty swallowing or breathing; if you experience such symptoms, contact your doctor immediately.

Other possible side effects are listed below.
Uncommon(may affect up to 1 in 100 people):

• irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety,
• migraine, headache, lethargy (fatigue, lack of energy), psychomotor agitation, dizziness, drowsiness,
• hypertension,
• abdominal pain, epigastric pain, nausea, oral ulcers, dry mouth, vomiting,
• increased bilirubin levels in the blood,
• skin inflammation, night sweats, itching, rash, generalized itching, dry skin,
• limb pain,
• glycosuria, proteinuria,
• menopausal symptoms,
• weakness, chest pain, decreased body temperature,
• abnormal liver function tests, weight gain.

Rare(may affect up to 1 in 1,000 people):

• increased number of seizures in children with central nervous system damage and epilepsy,
• hives, rash, redness, hand dermatitis, psoriasis, generalized rash, pruritic rash, nail changes,
• gynecomastia (breast enlargement in men),
• shingles,
• decreased white blood cell count, decreased platelet count,
• increased triglyceride levels in the blood, decreased calcium levels in the blood, decreased sodium levels in the blood,
• mood changes, aggression, agitation, crying, tension, disorientation, early morning awakening, increased libido (increased sex drive), depressive mood, depression,
• fainting, memory disorders, concentration disorders, dreamy state, restless legs syndrome, poor sleep quality, tingling or numbness,
• decreased visual acuity, blurred vision, increased lacrimation,
• orthostatic dizziness, balance disorders,
• angina pectoris, palpitations, tachycardia,
• hot flashes,
• gastroesophageal reflux disease, gastrointestinal disorders, oral ulcers, tongue ulcers, stomach upset, vomiting, abnormal bowel sounds, bloating, excessive salivation, bad breath, abdominal complaints, stomach disorders, gastritis,
• arthritis, muscle cramps, neck pain, nocturnal cramps,
• polyuria, hematuria, nocturia,
• prolonged, painful erection (priapism), prostatitis,
• fatigue, pain, thirst,
• increased liver enzyme activity, abnormal electrolyte levels in the blood, abnormal laboratory test results.

Frequency not known(cannot be estimated from the available data):

• galactorrhea

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 will help gather more information on the safety of this medicine.

5. How to store Melatonina Biofarm

Keep the medicine out of 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 month.
Store in the original packaging to protect from light.
No special precautions for storage temperature are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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,
croscarmellose sodium, 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 round embossing on one side, with a diameter of 7.0 mm ± 0.3 mm.
Melatonina Biofarm, 3 mg
round, white or almost white, biconvex tablets, with a diameter of 7.0 mm ± 0.3 mm.
Melatonina Biofarm, 5 mg
round, white or almost white, biconvex tablets, with a single break line on one side, with a diameter of 9.0 mm ± 0.3 mm.
Tablets are packaged in PVC/PVDC/Aluminum 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 authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: biofarm@biofarm.pl

Date of last revision of the leaflet: 20.12.2024