Patient Information Leaflet

Melatonin Neurim 2 mg prolonged-release tablets

melatonin
Please read all of this leaflet carefully before you start taking 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 other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Melatonin Neurim is and what it is used for

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

2. What you need to know before taking Melatonin Neurim

Do not take Melatonin Neurim

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 Melatonin Neurim.

if you have liver or kidney problems. Studies on the use of Melatonin Neurim in patients with liver or kidney disease have not been conducted; consult your doctor before taking Melatonin Neurim, 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 Melatonin Neurim in patients with autoimmune diseases have not been conducted; therefore, consult your doctor before taking Melatonin Neurim, as its use is not recommended.
Melatonin Neurim 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 Melatonin Neurim, since components of tobacco smoke can increase the metabolism of melatonin by the liver.

Children and adolescents
Do not administer this medicine to children aged 0 to 18 years, as it has not been tested and its effects are unknown. In children aged between 2 and 18 years, another melatonin-containing medicine might be more appropriate; please consult your doctor or pharmacist.

Other medicines and Melatonin Neurim
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 (reddish, scaly skin patches)), 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 addiction), 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).

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

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

Driving and using machines
Melatonin Neurim may cause drowsiness. If this occurs, you must not drive or operate machinery.
If you experience prolonged drowsiness, consult your doctor.

Melatonin Neurim contains lactose monohydrate
Melatonin Neurim 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 Melatonin Neurim

Always 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 Melatonin Neurim tablet (2 mg) to be taken orally every
day after a meal, 1–2 hours before going to bed. This dosage may be maintained for a period
of up to thirteen weeks.
The tablet must be swallowed whole. Melatonin Neurim tablets must not be
crushed or split.
If you take more Melatonin Neurim 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 higher than the maximum recommended dose, you may experience
drowsiness.
If you forget to take Melatonin Neurim
If you forget to take a tablet, take it as soon as you remember, provided it is still before bedtime; otherwise, wait until it is time for your next dose and then continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Melatonin Neurim
No harmful effects are known to occur in case of interruption or premature discontinuation of treatment.
No withdrawal symptoms associated with discontinuation of Melatonin Neurim after completion of therapy are known.
If you have any questions 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 everybody 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 (awareness of heartbeats)
Depression
Vision changes (including reduced vision)
Blurred vision
Disorientation
Dizziness (feeling dizzy)
Presence of red blood cells in the urine
Reduced number of white blood cells in the blood
Reduced platelet count, leading to increased bleeding or bruising
Psoriasis (red, scaly patches on the skin)

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 (tiredness, lack of energy), restlessness associated with increased activity, dizziness, fatigue,
hypertension, 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 the urine,
excess protein in the urine, abnormal 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 waking,
increased libido (increased sexual desire), low mood, memory deficit, attention disorders, dream-like
state, restless legs syndrome, poor quality sleep, tingling sensation, increased tear production,
postural dizziness (dizziness upon standing or sitting up), hot flushes, acid reflux, stomach discomfort,
mouth ulceration, tongue ulceration, stomach discomfort, vomiting, intestinal noises, intestinal gas,
excessive saliva production, bad breath, abdominal pain, stomach disorders, inflammation of the gastric
mucosa, eczema, rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain,
nocturnal cramps, prolonged erection which may be painful, inflammation of the prostate, fatigue,
pain, thirst, increased urine production, nocturnal urination, increased liver enzymes, abnormalities
in blood electrolyte tests, and abnormal laboratory test results.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Melatonin Neurim

Keep this medicine out of the 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 that month.
Do not store above 25°C. Keep in the original packaging to protect 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 Melatonin Neurim contains

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

Description of the appearance of Melatonin Neurim and pack sizes
Melatonin Neurim 2 mg prolonged-release tablets are round, biconvex tablets, white to almost white in colour. Each tablet box contains one blister strip with 7, 20 or 21 tablets, or alternatively two blister strips containing 15 tablets each (pack of 30 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux
75002 Paris
France
e-mail: [email protected]

Manufacturers:
Sites responsible for batch release in the European Economic Area (EEA):
Iberfar Indústria Farmacêutica S.A.
Estrada Consiglieri Pedroso 123
Queluz De Baixo
Barcarena
2734-501
Portugal

Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140
Alcalá de Henares
Madrid, 28805
Spain

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.