Package leaflet: Information for the patient

Eusom 2 mg prolonged-release tablets

Melatonin
Generic medicine
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 others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Eusom is and what it is used for

The active substance in Eusom, melatonin, belongs to a group of natural hormones produced by the body.
This medicine is used alone for the short-term treatment of primary insomnia (persistent difficulty in falling asleep or staying asleep, 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 Eusom

Do not take Eusom

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 Eusom:

If you have liver or kidney problems. Studies on the use of this medicine in people with liver or kidney disease have not been conducted; consult your doctor before taking this medicine, 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 the use of this medicine in people with autoimmune diseases have not been conducted; therefore, consult your doctor before taking this medicine, as its use is not recommended.
This medicine may cause drowsiness. Be cautious if you experience drowsiness, as it may impair your ability to perform activities such as driving vehicles.
Smoking may reduce the effectiveness of this medicine, 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 between 0 and 18 years, as it has not been tested and its effects are unknown. In children aged between 2 and 18 years, another medicine containing melatonin may be more appropriate; consult your doctor or pharmacist for advice.

Other medicines and Eusom
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
These medicines 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 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).

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

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

Driving and using machines
This medicine may cause drowsiness. If affected, do not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.

Eusom contains monohydrate lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Eusom

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 tablet (2 mg) 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. The tablets must not be crushed or split.
If you take more Eusom than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or
pharmacist as soon as possible.
Taking more than the recommended daily dose may cause drowsiness.
If you forget to take Eusom
If you forget to take a tablet, take it as soon as you remember, before going to bed, or 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 Eusom
No harmful effects are known to occur if treatment is interrupted or prematurely discontinued.
No withdrawal symptoms associated with discontinuation of this medicine have been reported after completion of therapy.
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 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
Awareness of your heartbeat
Depression
Visual impairment
Blurred vision
Disorientation
Dizziness (sensation of spinning or "dizziness")
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

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, high blood pressure, 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, abnormalities in liver function tests, and weight gain.
Rare: (may affect up to 1 in 1,000 people)
Herpes zoster, elevated levels of fats in the blood, low levels of calcium in serum, low levels of sodium in the blood,
mood changes, aggression, agitation, crying, stress symptoms, early morning awakening, increased sexual desire,
depressed mood, memory deficit, attention disturbance, dream-like state, restless legs syndrome, poor quality sleep,
sensation of pins and needles (tingling), tearing of the eyes, dizziness upon standing or sitting up, hot flushes,
acid reflux, stomach upset, mouth ulcers, tongue ulcers, stomach ache, vomiting, abnormal intestinal noises,
intestinal gas, excessive saliva production, bad breath, abdominal discomfort, gastric disturbance,
inflammation of the gastric mucosa, eczema, rash, hand dermatitis, itchy rash, nail disorder, arthritis,
muscle spasms, neck pain, night cramps, prolonged erection which may be painful, prostate inflammation,
tiredness, pain, thirst, increased urine production, nocturnal urination, increased liver enzymes,
abnormalities in blood electrolyte tests, and abnormalities in 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 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 Eusom

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. Keep 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Eusom 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 phosphate dibasic dihydrate, lactose monohydrate (see section 2 “Eusom contains lactose monohydrate”), silica (anhydrous colloidal), talc and magnesium stearate.

Description of the appearance of Eusom and contents of the pack
Eusom prolonged-release tablets are white to off-white, oval-shaped tablets, 5.2 mm x 10 mm in size, with "A6" engraved on one side.
Eusom is available in blisters of 30 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan - Italy
Manufacturer:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
IS: Eusom
IT: Eusom