Melabiorytm

Package leaflet: Information for the patient

Melabiorytm, 5 mg, tablets
Melatoninum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, 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 your symptoms do not improve or worsen, contact your doctor.

Table of contents of the leaflet

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

1. What Melabiorytm is and what it is used for

Melabiorytm 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 regulates the sleep-wake cycle over 24 hours.

Melabiorytm is indicated as an adjunctive treatment for sleep disorders associated with time zone changes or shift work, and for facilitating the regulation of the sleep-wake circadian rhythm in blind patients.

2. Important information before using Melabiorytm

When not to use Melabiorytm

• if the patient is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6),
• in children and adolescents,
• during pregnancy and breastfeeding,
• after alcohol consumption,
• if the patient has impaired liver or kidney function,
• if the patient has depression.

Warnings and precautions
Before starting to take Melabiorytm, discuss this with your doctor or pharmacist:

• if the patient has disorders of immune system function,
• if the patient has hormonal disorders,
• if the patient has epilepsy,
• if the patient is being treated with anticoagulant medicines.
  Smoking may reduce the effectiveness of the medicine.

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 effect is unknown.

Melabiorytm with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Fluvoxamine (an antidepressant) and other medicines metabolized in the liver, such as:
citalopram (an antidepressant), omeprazole, lanzoprazole (medicines used in peptic ulcer disease and gastroesophageal reflux disease) increase blood levels of melatonin when administered concomitantly.
Other medicines that may affect melatonin's action:

• 5- or 8-methoxypsoralen (used in the treatment of psoriasis),
• cimetidine (used in the treatment of peptic ulcer disease),
• estrogens (contraceptives and hormone replacement therapy),
• quinolones (antibacterial medicines),
• thioridazine (used in the treatment of psychiatric disorders),
• imipramine (used in the treatment of depression),
• carbamazepine (used in the treatment of epilepsy),
• rifampicin (an antibacterial medicine),
• sedatives and hypnotics, e.g. benzodiazepines, zaleplon, zolpidem and zopiclone, adrenergic receptor agonists/antagonists (such as certain types of medicines used to control blood pressure by vasoconstriction, nasal decongestants, blood pressure-lowering medicines),
• opioid receptor agonists or antagonists (such as medicines used in the treatment of drug addiction),
• prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs),
• antidepressants,
• tryptophan.

Taking Melabiorytm with alcohol
Do not consume alcohol while taking Melabiorytm, as alcohol reduces the effectiveness of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated during pregnancy and breastfeeding.

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

3. How to take Melabiorytm

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Swallow the tablet with water.

Dosage
Adults:
For sleep disorders associated with 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 to 3 consecutive days after completion of travel.

For circadian rhythm sleep-wake disorders, e.g. related to shift work:
1 mg to 5 mg once daily, taken one hour before bedtime.

For circadian rhythm sleep-wake disorders in blind individuals:
0.5 mg to 5 mg once daily, taken around 21:00–22:00. This dosage applies also to long-term treatment.

The therapeutic effect of the medicine in long-term treatment of circadian rhythm sleep-wake disorders may sometimes only become apparent after 2 weeks of treatment.

The established medical use of melatonin includes doses starting from 0.5 mg; the lowest effective dose of melatonin should be used.

Melabiorytm should only be used when effectiveness of other available lower-dose melatonin products has not been demonstrated.

Taking more Melabiorytm than recommended
In case of accidental overdose, 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.

If you forget to take Melabiorytm
Do not take a double dose to make up for the missed dose.

Stopping Melabiorytm
There are no known harmful effects of stopping or ending treatment earlier. No withdrawal symptoms have been observed after discontinuation of Melabiorytm 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 can cause adverse reactions, although not everybody will experience them.

Not common (may affect no more than 1 in 100 people):

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

Rare (may affect no more than 1 in 1,000 people):

• increased number 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),
• herpes zoster,
• 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 quality of sleep, 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 not known (cannot be estimated from the available data):

• hypersensitivity reaction,
• facial, lip or tongue swelling, which may interfere with swallowing and 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 also 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.: +48 22 49-21-301,
fax: +48 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 Melabiorytm

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging, protected from light.
Do not use this medicine after the expiry date stated on the packaging. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Melabiorytm contains

• The active substance is melatonin. Each tablet contains 5 mg of melatonin.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

What Melabiorytm looks like and contents of the pack
Melabiorytm is a round, white, biconvex, uncoated tablet.
Aluminium/PVC/PVDC blister in a cardboard box.
Pack sizes: 30, 60 or 90 tablets.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów