Package leaflet: Information for the user

MELATONIN DOC 2 mg prolonged-release tablets

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What MELATONIN DOC is and what it is used for
What you need to know before taking MELATONIN DOC
How to take MELATONIN DOC
Possible side effects
How to store MELATONIN DOC
Contents of the pack and other information

1. What MELATONINA DOC is and what it is used for

The active substance of MELATONINA DOC, melatonin, belongs to a group of natural hormones produced by the body.
MELATONINA DOC is used alone for the short-term treatment of primary insomnia (persistent difficulty falling asleep or staying asleep, or poor sleep quality) in patients aged 55 years and older.
"Primary" means that no underlying cause for the insomnia has been identified, including any medical, mental, or environmental cause.

2. What you need to know before taking MELATONINA DOC

Do not take MELATONINA DOC:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking MELATONINA DOC.

If you have liver or kidney problems. Studies on the use of MELATONINA DOC in people with liver or kidney disease have not been conducted; consult your doctor before taking MELATONINA DOC, as its use is not recommended.
If your doctor has told you that you have an intolerance to certain sugars.
If you have been diagnosed with an autoimmune disease (a condition in which the body is “attacked” by its own immune defenses). Studies on MELATONINA DOC in patients with autoimmune diseases have not been conducted; therefore, consult your doctor before taking MELATONINA DOC, as its use is not recommended.
MELATONINA DOC may cause drowsiness; be cautious if you experience drowsiness, as this may impair your ability to perform activities such as driving vehicles.
Smoking may reduce the effectiveness of MELATONINA DOC, as components of tobacco smoke can increase the metabolism of melatonin by the liver.

Children and adolescents
Do not administer this medicine to children and adolescents aged between 0 and 18 years, as it has not been tested and its effects are unknown. Another medicine containing melatonin may be more appropriate for this population; consult your doctor or pharmacist for advice.

Other medicines and MELATONINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include:

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

MELATONINA DOC with food, drinks, and alcohol
Take MELATONINA DOC after eating. Do not consume alcohol before, during, or after taking MELATONINA DOC, as alcohol reduces the effectiveness of MELATONINA DOC.

Pregnancy and breastfeeding
Do not take MELATONINA DOC if you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
MELATONINA DOC may cause drowsiness. If this occurs, do not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.

MELATONINA DOC contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take MELATONINA DOC

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one MELATONINA DOC tablet (2 mg) taken orally every day, after a meal, 1-2 hours before going to bed. This dosage may be maintained for up to thirteen weeks.
The tablet must be swallowed whole. MELATONINA DOC tablets must not be crushed or split.
Do not administer this medicine to children aged 0 to 18 years, as it has not been tested and its effects are unknown. Another medicinal product containing melatonin may be more appropriate for administration to this population.
If you take more MELATONINA DOC than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or pharmacist as soon as possible.
If you have taken a dose exceeding the maximum recommended dose, you may experience drowsiness.
If you forget to take MELATONINA DOC
If you forget to take a tablet, take it as soon as you remember, provided it is before bedtime; otherwise, wait until it is time to take the next dose, then continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking MELATONINA DOC
Harmful effects due to interruption or premature discontinuation of treatment are not known. Withdrawal symptoms after stopping MELATONINA DOC at the end of treatment are not known.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

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 caused by angina
Palpitations
Depression
Visual disturbances
Blurred vision
Disorientation
Dizziness (sensation of spinning)
Presence of red blood cells in urine
Reduced number of white blood cells in the blood
Reduction in platelets, resulting in increased bleeding or bruising
Psoriasis

Frequency not known: (cannot be estimated from the available data)

Hypersensitivity reactions
Swelling of the mouth or tongue
Skin swelling

If any of the following non-serious side effects occur, consult your doctor and/or seek medical advice:

Uncommon: (may affect up to 1 in 100 people)
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy, restlessness associated with increased activity, dizziness, fatigue, somnolence, hypertension, abdominal pain, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in blood composition that may cause yellowing of the skin or eyes, skin inflammation, night sweats, itching, rash, dry skin, limb pain, menopausal symptoms, feeling of weakness, presence of glucose in urine, excess protein in urine, abnormalities in liver function tests and weight gain.

Rare: (may affect up to 1 in 1,000 people)
Herpes zoster (shingles), increased levels of fats in the blood, low serum calcium levels, low sodium levels in the blood, mood changes, aggression, agitation, crying, stress symptoms, early morning awakening, increased libido (increased sexual desire), depressed mood, memory deficit, attention disorders, dreamy state, restless legs syndrome, poor quality sleep, tingling sensation, increased lacrimation, postural dizziness (dizziness upon standing or sitting), hot flushes, acid reflux, stomach disturbances, mouth ulcers, tongue ulcers, stomach discomfort, vomiting, intestinal noises, intestinal gas, excessive salivation, bad breath, abdominal pain, stomach disorders, inflammation of the gastric mucosa, eczema, skin rash, hand dermatitis, pruritic rash, nail disorders, arthritis, muscle spasms, neck pain, night cramps, prolonged erection which may be painful, inflammation of the prostate, fatigue, pain, thirst, increased urine production, nocturia, elevated liver enzymes, abnormalities in blood electrolyte tests and abnormalities in laboratory test results.

Frequency not known: (cannot be estimated from the available data)
Abnormal milk secretion.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MELATONINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry
date refers to the last day of that month.
Do not store above 25 °C. Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MELATONINA DOC contains

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

Description of the appearance of MELATONINA DOC and pack sizes
MELATONINA DOC 2 mg prolonged-release tablets are round, biconvex tablets, white to off-white in colour.
Each package contains 7, 20, 21 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan, Italy
Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o., 14A Ostrzykowizna Street, 05-170 Zakroczym, Poland.

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Meldream PR
Cyprus MELATONIN MEDICAIR
Denmark Melatonin Senaxa
Finland Melatonin Senaxa
France MELATONINE VENIPHARM LP 2 mg, comprimé à libération prolongée
Germany Melatonin Senaxa 2 mg Retardtabletten
Greece MELATONIN/MEDICAIR
Italy MELATONINA DOC
Malta Meldream PR
Norway Melatonin Senaxa
Spain Melatonin Senaxa
Sweden Melatonin Senaxa