Patient Information Leaflet

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

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Table of Contents

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

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

Melatonina Polfarmex 5 mg tablets contain melatonin as the active substance.
This hormone occurs naturally in the human body and is produced by the pineal gland,
located in the central nervous system. Melatonin plays an important role in regulating the
circadian rhythm. It controls the sleep-wake cycle over 24 hours.
Melatonina Polfarmex is indicated as an adjunctive treatment for sleep disorders associated
with time zone changes or resulting from shift work, and for facilitating the regulation of the
sleep-wake circadian rhythm in blind patients.

2. Information before using Melatonina Polfarmex

When not to use Melatonina Polfarmex

if the patient is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Melatonina Polfarmex, discuss this with your doctor or
pharmacist:

if the patient has disorders of the immune system (e.g. autoimmune disease),
if the patient has hormonal disorders,
if the patient has epilepsy,
if the patient is being treated with anticoagulant medicines,
if the patient has liver or kidney disease,
in patients with depression.

Smoking may reduce the effectiveness of the medicine.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, as it has not been studied in this
group of patients and its effect is unknown.
Melatonina Polfarmex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has taken recently, as well as any medicines the patient plans to take. This includes, among others:

fluvoxamine (an antidepressant),
other medicines metabolized in the liver, such as: citalopram (an antidepressant), omeprazole, lanzoprazole (medicines used in peptic ulcer disease and gastroesophageal reflux disease), as they may increase blood concentration of melatonin administered simultaneously.

Other medicines that may affect melatonin's action:

5- or 8-methoxypsoralen (used in psoriasis treatment),
cimetidine (used in peptic ulcer treatment),
estrogens (contraceptives and hormone replacement therapy),
quinolones (antibacterial medicines),
thioridazine (used in the treatment of psychiatric disorders),
imipramine (used in depression treatment),
carbamazepine (used in epilepsy treatment),
rifampicin (an antibacterial medicine),
sedatives and hypnotics, 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 or antagonists (i.e. medicines used in drug addiction treatment),
prostaglandin inhibitors (i.e. non-steroidal anti-inflammatory drugs),
antidepressants,
tryptophan.

Melatonina Polfarmex and alcohol
Do not consume alcohol while taking Melatonina Polfarmex, as alcohol may reduce the effectiveness of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient data, Melatonina Polfarmex should not be used during pregnancy and breastfeeding.
Driving and operating machinery
After taking Melatonina Polfarmex, do not drive or operate machinery, as drowsiness may occur after taking the medicine, leading to reduced concentration.
3. How to use Melatonina Polfarmex
This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed with water.
Dosage
Established medical use of melatonin includes doses from 0.5 mg; the lowest effective dose of melatonin should be used.
Melatonina Polfarmex should only be used when the indication requires a 5 mg dose and when effectiveness has not been demonstrated with other, lower doses of melatonin available on the market.
Adults
For sleep disorders related to time zone changes:
5 mg of melatonin once daily, after sunset, starting on the first day of travel.
Continue treatment for up to 2 to 3 consecutive days after completion of travel.
For circadian rhythm sleep-wake disorders, e.g. due to shift work:
5 mg once daily, one hour before bedtime.
For circadian rhythm sleep-wake disorders in blind individuals:
5 mg once daily, around 9:00–10:00 PM.
Use of a higher than recommended dose of Melatonina Polfarmex
If an overdose is accidentally taken, contact a doctor or pharmacist immediately.
Taking a higher than recommended daily dose may, in individual cases, cause drowsiness, disorientation, or the occurrence of psychosis.
Missed dose of Melatonina Polfarmex
Do not take a double dose to make up for a missed dose.
If a dose is missed, take the next dose at the usual time.
Stopping Melatonina Polfarmex
There are no known harmful effects of stopping or prematurely discontinuing treatment.
No withdrawal symptoms have been observed after discontinuation of Melatonina Polfarmex treatment.
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 may cause adverse reactions, although they do not occur in everyone.

Uncommon (occurs in more than 1 in 1,000 but less than 1 in 100 patients):

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

Rare (occurs in more than 1 in 10,000 but less than 1 in 1,000 patients):

increased frequency of epileptic seizures in children with central nervous system disorders and epilepsy,
urticaria, rash, erythema, hand dermatitis, psoriasis, generalized rash, pruritic rash, nail plate abnormalities,
breast enlargement in males (gynaecomastia),
shingles,
decreased white blood cell count, decreased platelet count, increased blood triglyceride concentration, decreased blood calcium concentration, decreased blood sodium concentration,
mood changes, aggression, agitation, crying, tension symptoms, disorientation, early morning awakening, increased libido (increased sexual drive), depressed mood, depression,
fainting, memory disturbances, concentration difficulties, dream-like state, restless legs syndrome, poor sleep quality, tingling or numbness,
reduced visual acuity, blurred vision, excessive tearing,
dizziness upon positional change, balance disorders,
angina pectoris, palpitations, tachycardia,
hot flushes,
gastroesophageal reflux disease, gastrointestinal disturbances, blisters on the oral mucosa, tongue ulceration, dyspepsia, vomiting, abnormal intestinal peristalsis sounds, bloating, excessive salivation, halitosis, 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 available data):

hypersensitivity reaction,
swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing; if such symptoms occur, contact a doctor immediately,
galactorrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
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 the medicine.

5. How to store the medicine Melatonina Polfarmex

Store below 25°C.
Keep in the original packaging. Protect from light and moisture.
The medicine should be stored out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Melatonina Polfarmex contains

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

What Melatonina Polfarmex looks like and contents of the pack
White to off-white tablets, circular, 6 mm nominal diameter,
flat on both sides, without spots or damage.
The HDPE container contains 30 or 60 tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland
Tel.: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]