Melatonina Polfarmex

Leaflet attached to the packaging: patient information

Melatonin Polfarmex, 5 mg, tablets

Melatonin

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a 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 any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

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

Melatonina Polfarmex, 5 mg, tablets contain the active substance melatonin.
Melatonin is a hormone that occurs naturally in the human body. It is produced by the pineal gland,
located in the central nervous system. Melatonin plays an important role in regulating the
circadian rhythm. It regulates sleep and wakefulness during the day.
Melatonina Polfarmex is indicated as an auxiliary agent in sleep disorders related to
time zone changes or resulting from shift work, and to facilitate the regulation of the daily rhythm
of sleep and wakefulness in blind patients.

2. Important information before taking Melatonina Polfarmex

When not to take Melatonina Polfarmex

• if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Melatonina Polfarmex, discuss it with your doctor or pharmacist:

• if you have immune system disorders (e.g. autoimmune disease),
• if you have hormonal disorders,
• if you have epilepsy,
• if you are being treated with anticoagulant medications,
• if you have liver or kidney disease,
• in patients with depression.

Smoking may reduce the effectiveness of the medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it has not been tested in this
group of patients and its effects are unknown.

Melatonina Polfarmex and other medicines

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

• fluvoxamine (an antidepressant),
• other medicines that are metabolized in the liver, such as: citalopram (an antidepressant), omeprazole, lansoprazole (medicines used in gastric ulcer and gastroesophageal reflux disease), as they increase the concentration of melatonin in the blood.

Other medicines that may affect melatonin:

• 5- or 8-methoxypsoralen (used in the treatment of psoriasis),
• cimetidine (used in the treatment of gastric ulcers),
• estrogens (contraceptives and hormone replacement therapy),
• quinolones (antibacterial medicines),
• thioridazine (used in the treatment of mental disorders),
• imipramine (used in the treatment of depression),
• carbamazepine (used in the treatment of epilepsy),
• rifampicin (an antibacterial medicine),
• sedatives and anxiolytics, e.g. benzodiazepines, zaleplon, zolpidem, and zopiclone,
• adrenergic receptor agonists/antagonists (i.e. certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure-lowering medicines),
• opioid receptor agonists/antagonists (i.e. medicines used in the treatment of drug addiction),
• prostaglandin inhibitors (i.e. nonsteroidal anti-inflammatory medicines),
• antidepressants,
• tryptophan.

Melatonina Polfarmex and alcohol

Do not consume alcohol while taking Melatonina Polfarmex, as it reduces the effectiveness of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Due to the lack of sufficient data, Melatonina Polfarmex should not be taken during pregnancy and breastfeeding.

Driving and using machines

After taking the medicine, do not drive or operate machinery, as it may cause drowsiness leading to decreased concentration.
3 How to take Melatonina Polfarmex
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Swallow the tablet with water.
Dosage
The established medicinal use of melatonin includes doses from 0.5 mg; use the smallest effective dose of melatonin.
Melatonina Polfarmex should only be taken when the indication is for a 5 mg dose and the effectiveness of other, lower doses of melatonin available on the market has not been demonstrated.

Adults

In sleep disorders related to time zone changes:
5 mg of melatonin once a day, after dark, starting from the first day of travel.
Continue treatment for a maximum of 2 to 3 consecutive days after the end of the trip.
In disorders of the daily rhythm of sleep and wakefulness related to shift work:
5 mg per day, 1 hour before bedtime.
In disorders of the daily rhythm of sleep and wakefulness in blind people:
5 mg once a day, around 9-10 pm.

Taking a higher dose of Melatonina Polfarmex than recommended

In case of accidental ingestion of too high a dose, 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 Melatonina Polfarmex

Do not take a double dose to make up for a missed dose.
In case of a missed dose, take the next dose at the usual time.

Stopping treatment with Melatonina Polfarmex

No harmful effects of stopping or prematurely ending treatment have been reported.
No withdrawal symptoms have been observed after stopping treatment with Melatonina Polfarmex.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (more than 1 in 1000, but less than 1 in 100 patients) side effects include:

• 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, nausea,
• increased bilirubin levels in the blood,
• skin rash, 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 (more than 1 in 10,000, but less than 1 in 1000 patients) side effects include:

• increased number of seizures in children with central nervous system damage and epilepsy,
• hives, rash, erythema, 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 sexual desire), depressive mood, depression,
• fainting, memory disorders, concentration disorders, dreamy state, restless legs syndrome, poor sleep quality, paresthesia (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):

• hypersensitivity reaction,
• facial, lip, or tongue swelling, which may cause difficulty swallowing; if such symptoms occur, seek medical attention immediately,
• galactorrhea (milk secretion).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Melatonina Polfarmex

Store in a temperature below 25°C.
Store in the original packaging. Protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label on the container after: "Expiry date (EXP)". The expiry date refers to the last day of the month.
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 Polfarmex contains

• The active substance is melatonin.
• The other ingredients are: microcrystalline cellulose, colloidal silica, anhydrous, magnesium stearate.

What Melatonina Polfarmex looks like and contents of the pack

White to light cream-colored tablets, round with a nominal diameter of 6 mm,
flat on both sides, without spots and damage.
HDPE container contains 30 or 60 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: