Melatonina Biofarm

Leaflet attached to the packaging: patient information

Melatonin Biofarm, 2 mg, tablets

Melatonin Biofarm, 3 mg, tablets

Melatonin Biofarm, 5 mg, tablets

Melatonin

You should carefully read the contents of the 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

What is Melatonin 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. Melatonin Biofarm is a synthetic equivalent of the natural hormone.
Melatonin Biofarm 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 taking Melatonin Biofarm

When not to take Melatonin Biofarm

• if the patient has been diagnosed with an allergy to melatonin or any of the other ingredients of Melatonin Biofarm (listed in section 6),
• after consuming alcohol,
• during pregnancy or breastfeeding.

When to exercise special caution when taking Melatonin Biofarm

Before starting to take Melatonin Biofarm, the patient should consult a doctor if they have:
liver function disorders, depression, immune system function disorders, hormonal disorders, epilepsy, or kidney function disorders.
Smoking may decrease melatonin levels.

Taking Melatonin Biofarm with other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Fluvoxamine and liver-metabolized drugs such as citalopram, omeprazole, and lansoprazole increase the blood concentration of melatonin taken at the same time.
• 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

This medicine should not be taken by children and adolescents from 0 to 18 years old, as it has not been tested in this group of patients and its effects are unknown.

Taking Melatonin Biofarm with alcohol

During treatment with Melatonin Biofarm, the patient should not consume alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Melatonin Biofarm is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

After taking the medicine, the patient should 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 Melatonin Biofarm

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The tablet should be swallowed, washed down with water.
The patient should 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 Melatonin Biofarm:
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. Continue treatment 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, 1 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.
The time of taking the medicine 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 sometimes only after 2 weeks of treatment.

Patients with liver function disorders

The medicine should not be taken by patients with liver function disorders.

Patients with kidney function disorders

The medicine should not be taken by patients with kidney function disorders.

Elderly patients

Dose adjustment is not necessary in elderly patients.

Taking a higher dose of Melatonin Biofarm than recommended

In case of accidental ingestion of too high a dose, the patient should contact a 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 Melatonin Biofarm

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Melatonin Biofarm

No harmful effects of stopping or ending treatment early have been found. It has not been found that taking Melatonin Biofarm causes any withdrawal symptoms after treatment is stopped.
In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following serious side effects, they should immediately inform their doctor and stop taking this medicine:
Frequency not known(cannot be estimated from the available data):

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

Other possible side effects are listed below.
Uncommon(may occur in 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 occur in up to 1 in 1,000 people):

• increased number of seizures in children with central nervous system damage and epilepsy,
• hives, rash, erythema, hand dermatitis, psoriasis, generalized rash, pruritic rash, changes in nail plate pathology,
• gynecomastia 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 sexual desire), depressive mood, depression,
• fainting, memory disorders, concentration disorders, dreamy state, restless legs syndrome, poor sleep quality, paresthesia,
• 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):

• lactation

Reporting side effects
If side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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 can help gather more information on the safety of the medicine.

5. How to store Melatonin Biofarm

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from light.
There are no special storage temperature recommendations for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Melatonin Biofarm contains

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

What Melatonin Biofarm looks like and contents of the pack

Melatonin Biofarm, 2 mg
round, white or almost white tablets, biconvex, with a round engraving on one side, with a diameter of 7.0 mm ± 0.3 mm.
Melatonin Biofarm, 3 mg
round, white or almost white tablets, biconvex, with a diameter of 7.0 mm ± 0.3 mm.
Melatonin Biofarm, 5 mg
round, white or almost white tablets, biconvex, with a single transverse notch, with a diameter of 9.0 mm ± 0.3 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
Melatonin Biofarm, 2 mg, tablets: 20, 30, 60, 90 tablets
Melatonin Biofarm, 3 mg, tablets: 10, 20, 30, 60, 90 tablets
Melatonin 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 the last revision of the leaflet: 20.12.2024