Melabioritm

Package Leaflet: Information for the Patient

Melabiorytm, 5 mg, Tablets

Melatonin

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of Contents of the Leaflet

• 1. What is Melabiorytm and what is it 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 is Melabiorytm and what is it used for

Melabiorytm, 5 mg, tablets contain the active substance melatonin. This hormone 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 biological daily rhythm. It regulates sleep and wakefulness during the day.
Melabiorytm is indicated as an auxiliary agent in sleep disorders associated with time zone changes or shift work, and to facilitate the regulation of the daily sleep-wake rhythm in blind patients.

2. Important information before taking Melabiorytm

When not to take Melabiorytm

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

Warnings and precautions

Before starting to take Melabiorytm, the doctor or pharmacist should be consulted:

• if the patient has immune system disorders (immunological disorders),
• if the patient has hormonal disorders,
• if the patient has epilepsy,
• if the patient is being treated with anticoagulant medications. Smoking may reduce the effectiveness of the medication.

Children and adolescents

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

Melabiorytm and other medications

The doctor or pharmacist should be informed about all medications currently being taken by the patient, as well as any medications planned to be taken.
Fluvoxamine (an antidepressant) and other medications that undergo liver metabolism, such as citalopram (an antidepressant), omeprazole, lansoprazole (medications used for stomach ulcers and gastroesophageal reflux disease) increase the blood concentration of melatonin taken at the same time.
Other medications that may affect melatonin:

• 5- or 8-methoxypsoralen (used to treat psoriasis),
• cimetidine (used to treat stomach ulcers),
• estrogens (contraceptives and hormone replacement therapy),
• quinolones (antibacterial medications),
• thioridazine (used to treat mental disorders),
• imipramine (used to treat depression),
• carbamazepine (used to treat epilepsy),
• rifampicin (an antibacterial medication),
• sleeping pills and sedatives, e.g. benzodiazepines, zaleplon, zolpidem, and zopiclone, agonists/antagonists of adrenergic receptors (such as certain types of medications used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure-lowering medications),
• agonists or antagonists of opioid receptors (such as medications used to treat drug addiction),
• prostaglandin inhibitors (such as non-steroidal anti-inflammatory medications),
• antidepressants,
• tryptophan.

Taking Melabiorytm with alcohol

Alcohol should not be consumed while taking Melabiorytm, as it reduces the effectiveness of the medication.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medication.
The medication is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

After taking the medication, the patient should not drive vehicles or operate machinery, as drowsiness may occur, leading to decreased concentration.

3. How to take Melabiorytm

This medication should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
The tablet should be swallowed with water.
Dosage
Adults:
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. The treatment should be continued for 2 to 3 consecutive 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,
0.5 mg to 5 mg should be taken once a day, around 9-10 pm. This dosage also applies to long-term use of the medication.
The effect of the medication in the treatment of long-term sleep-wake rhythm disorders may be observed sometimes only after 2 weeks of taking the medication.
The established medical use of melatonin includes doses from 0.5 mg; the smallest effective dose of melatonin should be used.
Melabiorytm should only be used when the effectiveness of other, lower doses of melatonin available on the market has not been demonstrated.

Taking a higher dose of Melabiorytm than recommended

In case of accidental ingestion of too high a dose, the doctor or pharmacist should be contacted as soon as possible.
Taking a higher dose than recommended may, in individual cases, cause drowsiness, disorientation, or psychosis.

Missing a dose of Melabiorytm

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

Stopping Melabiorytm treatment

No harmful effects of stopping or ending treatment early have been reported. No withdrawal symptoms have been observed after stopping Melabiorytm treatment.
In case of any further doubts about the use of this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Melabiorytm can cause side effects, although not everybody gets them.
Uncommon(may occur in less than 1 in 100 people):

• irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, fear,
• 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 less than 1 in 1000 people):

• 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, tingling or numbness,
• decreased visual acuity, blurred vision, increased lacrimation,
• vertigo when changing position, balance disorders,
• angina pectoris, palpitations, tachycardia,
• hot flashes,
• gastroesophageal reflux disease, gastrointestinal disorders, oral mucosa blisters, 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, the doctor should be contacted immediately,
• galactorrhea.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist, or nurse should be informed. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 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 the medication.

5. How to store Melabiorytm

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging to protect from light.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Melabiorytm contains

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

What Melabiorytm looks like and what the pack contains

The medication is round, white, biconvex, uncoated tablets.
Aluminum/PVC/PVDC blisters in a cardboard box.
Pack sizes: 30, 60, or 90 tablets.

Marketing authorization 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

Date of last revision of the leaflet: