Melanoc Pr

Package Leaflet: Information for the Patient

Melanoc PR, 2 mg, Prolonged-Release Tablets

Melatonin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Melanoc PR and what is it used for
• 2. Important information before taking Melanoc PR
• 3. How to take Melanoc PR
• 4. Possible side effects
• 5. How to store Melanoc PR
• 6. Package contents and other information

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

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

2. Important information before taking Melanoc PR

When not to take Melanoc PR

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

Warnings and precautions

Before taking Melanoc PR, discuss it with your doctor or pharmacist.

• If you have kidney or liver problems. There have been no studies on the use of Melanoc PR in people with liver or kidney disease; you should consult your doctor before taking this medication, as its use is not recommended in such cases.
• If you have been diagnosed with intolerance to some sugars.
• If you have been diagnosed with an autoimmune disease (in which the body is attacked by its own immune system). There have been no studies on the use of Melanoc PR in people with autoimmune diseases; therefore, you should consult your doctor before taking this medication, as its use is not recommended in such cases.
• Melanoc PR may cause drowsiness; be cautious if drowsiness affects you, as it may impair your ability to perform certain activities, such as driving.
• Smokingmay reduce the effectiveness of Melanoc PR, as tobacco smoke components may accelerate the breakdown of melatonin in the liver.

Children and adolescents

Do not give this medication to children and adolescents from 0 to 18 years old, as it has not been tested in this patient group and its effects are unknown. For adolescents from 2 to 18 years old, another melatonin-containing medication may be more suitable. Consult your doctor or pharmacist.

Melanoc PR and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. These include:

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

Using Melanoc PR with food, drink, and alcohol

Take Melanoc PR after a meal. Do not consume alcohol before, during, or after taking Melanoc PR, as it reduces the medication's effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, do not take Melanoc PR. Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Melanoc PR may cause drowsiness. In such cases, do not drive or operate machinery. If drowsiness persists, consult your doctor.

Melanoc PR contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

3. How to take Melanoc PR

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your 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 can be continued for up to 13 weeks.
Swallow the tablet whole. Do not crush or break Melanoc PR prolonged-release tablets.

Overdose of Melanoc PR

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
Taking more than the recommended daily dose of Melanoc PR may cause drowsiness.

Missed dose of Melanoc PR

If you miss a dose, take the next tablet before bedtime when you remember, or wait until it is time for your next dose and then continue with your regular treatment schedule.
Do not take a double dose to make up for a missed dose.

Stopping Melanoc PR treatment

No harmful effects have been reported if Melanoc PR treatment is stopped or discontinued prematurely. No withdrawal symptoms have been observed after stopping Melanoc PR treatment.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Melanoc PR can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Melanoc PR and immediatelycontact your doctor:
Uncommon: (may affect up to 1 in 100 people)

• Chest pain

Rare: (may affect up to 1 in 1,000 people)

• Loss of consciousness or fainting
• Severe chest pain due to angina
• Palpitations
• Depression
• Visual disturbances
• Blurred vision
• Disorientation
• Vertigo of labyrinthine origin
• Presence of red blood cells in urine
• Decreased white blood cell count
• Decreased platelet count, which may increase the risk of bleeding or bruising
• Psoriasis

In case of the following non-serious side effects, contact your doctor or pharmacist:
Uncommon: (may affect up to 1 in 100 people)

• Irritability
• Nervousness
• Restlessness
• Insomnia
• Abnormal dreams
• Nightmares
• Anxiety
• Migraine
• Headache
• Lethargy (fatigue, lack of energy)
• Restlessness associated with increased activity
• Dizziness
• Asthenia
• High blood pressure
• Upper abdominal pain
• Nausea
• Oral ulcers
• Dry mouth
• Nausea
• Changes in blood composition that may cause yellowing of the skin and eyes
• Dermatitis
• Nocturnal sweating
• Pruritus
• Rash, dry skin
• Limb pain
• Menopausal symptoms
• Weakness
• Glycosuria
• High protein levels in urine
• Abnormal liver function
• Weight gain

Rare: (may affect up to 1 in 1,000 people)

• Herpes zoster
• High levels of lipids in the blood
• Low calcium levels in blood serum
• Low sodium levels in blood
• Mood changes
• Aggression
• Excitement
• Crying
• Tension
• Early morning awakening
• Increased libido (increased sex drive)
• Depressive mood
• Memory disturbances
• Attention disturbances
• Dreamy state
• Restless legs syndrome
• Poor quality sleep
• Paresthesia
• Lacrimation
• Orthostatic dizziness
• Hot flashes
• Gastroesophageal reflux disease
• Gastrointestinal disorders
• Oral blisters
• Tongue ulcers
• Gastrointestinal upset
• Vomiting
• Abnormal bowel sounds
• Flatulence
• Excessive salivation
• Unpleasant mouth odor
• Abdominal discomfort
• Gastrointestinal disorders
• Gastritis
• Rash
• Skin rash
• Dermatitis of the hands
• Pruritic rash
• Nail changes
• Arthritis
• Muscle cramps
• Neck pain
• Nocturnal cramps
• Prolonged erection that may cause pain
• Prostatitis
• Fatigue (tiredness)
• Pain
• Thirst
• Polyuria
• Nocturia
• Increased liver enzyme activity
• Abnormal electrolyte levels in blood
• Abnormal laboratory test results

Frequency not known: (frequency cannot be estimated from the available data)
Hypersensitivity reaction, swelling of the mouth or tongue, skin swelling, or abnormal milk secretion by the breasts.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 to gather more information on the safety of this medication.

5. How to store Melanoc PR

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents 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: ammonio methacrylate copolymer (type B), calcium hydrogen phosphate dihydrate, lactose monohydrate, colloidal silica anhydrous, talc, and magnesium stearate.

What Melanoc PR looks like and package contents

Melanoc PR 2 mg prolonged-release tablets are available in the form of round, biconvex tablets with a diameter of 8.0 ± 0.3 mm and a white or almost white color without spots or damage.
The medication is available in PVC/PVDC/Aluminum blisters packaged in a cardboard box.
The package contains 7, 20, 21, or 30 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14 A
05-170 Zakroczym
Phone: +48 22 785 20 69

This medication has been authorized in the Member States of the European Economic Area under the following names:

Malta: Melanoc PR
Poland: Melanoc PR

Date of last revision of the package leaflet: