Patient Information Leaflet: Read this leaflet carefully before taking the medicine

Melanoc PR, 2 mg, prolonged-release tablets
Melatoninum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Melanoc PR is and what it is used for

The active substance in Melanoc PR, melatonin, belongs to a group of natural hormones produced by the human body.
Melanoc PR is used alone in the short-term treatment of primary insomnia (persistent difficulties in falling asleep or maintaining sleep continuity, or poor sleep quality) in patients aged 55 years and older. "Primary" means that the insomnia has no identified cause, including medical, psychological, or environmental causes.

2. Important information before taking Melanoc PR

When not to take Melanoc PR

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

Warnings and precautions
Before starting to take Melanoc PR, discuss this with your doctor or pharmacist.

If the patient has impaired kidney or liver function. Studies on the use of Melanoc PR in patients with liver or kidney disease have not been conducted; the patient should consult a doctor before taking this medicine, as its use is not recommended in such cases.
If the patient has been diagnosed with intolerance to certain sugars.
If the patient has been diagnosed with an autoimmune disease (a condition in which the body is attacked by its own immune system). Studies on the use of Melanoc PR in patients with autoimmune diseases have not been conducted; therefore, the patient should consult a doctor before starting this medicine, as its use is not recommended in such cases.
Melanoc PR may cause drowsiness; caution is advised if drowsiness affects the patient, as it may impair the ability to perform certain activities, such as driving.
Smoking may reduce the effectiveness of Melanoc PR, as components of tobacco smoke may accelerate the breakdown of melatonin in the liver.

Children and adolescents
Do not use this medicine in children and adolescents aged 0 to 18 years, as it has not been tested in this patient group and its effects are unknown. For use in adolescents aged 2 to 18 years, another melatonin-containing medicine may be more appropriate. Consult a doctor or pharmacist.
Melanoc PR and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to take. These include:

Fluvoxamine (used in the treatment of depression and obsessive-compulsive disorder), psoralens (used in the treatment of skin disorders such as psoriasis), cimetidine (used in the treatment of stomach disorders such as ulcers), quinolones and rifampicin (used in the treatment of bacterial infections), estrogens (used in contraceptive medicines and hormone replacement therapy), and carbamazepine (used in the treatment of epilepsy).
Adrenergic receptor agonists/antagonists (such as certain medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure-lowering medicines), opioid receptor agonists/antagonists (such as medicines used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan, and alcohol.
Benzodiazepines and non-benzodiazepine sleep medicines (medicines used to induce sleep, such as zaleplon, zolpidem, and zopiclone).
Thioridazine (used in the treatment of schizophrenia) and imipramine (used in the treatment of depression).

Taking Melanoc PR with food, drink, and alcohol
Melanoc PR should be taken after a meal. Do not consume alcohol before, during, or after taking Melanoc PR, as it reduces 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 baby, she should not take Melanoc PR. Consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Melanoc PR may cause drowsiness. In such cases, do not drive or operate machinery. If drowsiness persists, consult a doctor.
Melanoc PR contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Melanoc PR

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Melanoc PR is one tablet (2 mg) taken orally once daily after a meal,
1-2 hours before bedtime. This dose may be continued for up to thirteen weeks.
The tablet should be swallowed whole. Melanoc PR prolonged-release tablets must not be crushed or split.
Taking more Melanoc PR than recommended
If an overdose is taken, contact a doctor or pharmacist immediately.
Taking a higher than recommended daily dose may cause drowsiness.
If you miss a dose of Melanoc PR
If a dose is missed, take the next tablet at bedtime when remembered, or wait until the next scheduled dose and then resume the normal dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Melanoc PR treatment
There are no known harmful effects associated with stopping or prematurely discontinuing treatment.
No withdrawal symptoms have been reported after discontinuation of Melanoc PR.
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 everyone will experience them.
If any of the following serious adverse reactions occur in a patient, the medicine must be discontinued and the patient should immediately contact a doctor:

Uncommon (may occur in up to 1 in 100 patients):

Chest pain

Rare (may occur in up to 1 in 1000 patients):

Loss of consciousness or fainting
Severe chest pain due to angina
Palpitations
Depression
Visual disturbances
Blurred vision
Disorientation
Vertigo
Presence of red blood cells in urine
Decreased number of white blood cells in blood
Reduced platelet count, increasing the risk of bleeding or bruising
Psoriasis

If any of the following non-serious adverse reactions occur, contact a doctor and/or seek medical advice:

Uncommon (may occur in up to 1 in 100 patients):

Irritability
Nervousness
Anxiety
Insomnia
Unusual dreams
Nightmares
Restlessness
Migraine
Headache
Lethargy (fatigue, lack of energy)
Restlessness associated with increased activity
Dizziness
Asthenia
High blood pressure
Upper abdominal pain
Indigestion
Oral ulceration
Dry mouth
Nausea
Blood abnormalities that may cause yellowing of the skin and whites of the eyes
Skin inflammation
Night sweats
Itching
Rash, dry skin
Limb pain
Menopausal symptoms
Weakness
Glucosuria (excretion of glucose in urine)
Excessive protein in urine
Abnormal liver function
Weight gain

Rare (may occur in up to 1 in 1000 patients):

Herpes zoster
Elevated blood lipid levels
Low serum calcium levels
Low blood sodium levels
Mood changes
Aggression
Excitement
Crying
Tension symptoms
Early morning awakening
Increased libido (increased sexual drive)
Depressed mood
Memory disturbances
Attention disturbances
Dream-like state
Restless legs syndrome
Poor sleep quality
Tingling sensation
Watery eyes
Dizziness upon standing or while sitting
Hot flushes
Gastroesophageal reflux disease
Gastric disturbances
Blisters in the mouth
Tongue ulceration
Upset stomach
Vomiting
Abnormal bowel sounds
Flatulence
Excessive salivation
Unpleasant breath odour
Abdominal discomfort
Stomach disorders
Gastritis
Eruption
Skin rash
Hand dermatitis
Itchy rash
Nail plate changes
Arthritis
Muscle cramps
Neck pain
Nocturnal cramps
Prolonged erection that may be painful
Prostatitis
Feeling of fatigue (tiredness)
Pain
Thirst
Passing large amounts of urine
Nocturia (urinating at night)
Increased liver enzyme activity
Abnormal blood electrolyte levels
Abnormal laboratory test results

Frequency unknown (frequency cannot be estimated from available data):
Hypersensitivity reactions, swelling of the lips or tongue, skin swelling, or abnormal milk secretion from the breasts.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 provide more information on the safety of this medicine.

5. How to store Melanoc PR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C. Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Melanoc PR contains

The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
The other ingredients (excipients) are: methacrylic acid-ammonium methacrylate copolymer (type B), calcium hydrogen phosphate dihydrate, lactose monohydrate, colloidal anhydrous silica, talc, and magnesium stearate.

What Melanoc PR looks like and contents of the pack
Melanoc PR 2 mg prolonged-release tablets are available as white or off-white, circular, biconvex tablets, 8.0 ± 0.3 mm in diameter, free from spots and defects.
The medicine is available in blisters made of PVC/PVDC/aluminium foil, packed in a cardboard box.
The pack contains 7, 20, 21 or 30 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14 A
05-170 Zakroczym
Tel. +48 22 785 20 69
This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Malta: Melanoc PR
Poland: Melanoc PR