Patient Information Leaflet

Melatonin Viatris 2 mg prolonged-release tablets

Equivalent medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

The active substance of Melatonin Viatris, melatonin, belongs to a group of natural hormones produced by the body.
Melatonin Viatris 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 should know before taking Melatonin Viatris

Do not take Melatonin Viatris

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonin Viatris:

if you have liver or kidney problems. Studies on the use of melatonin in people with liver or kidney disease have not been conducted; consult your doctor before taking Melatonin Viatris, 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 in people with autoimmune diseases have not been carried out; therefore, consult your doctor before taking Melatonin Viatris, as its use is not recommended.
Melatonin Viatris 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 Viatris, 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 melatonin-containing medicine might be more appropriate; please consult your doctor or pharmacist.
Other medicines and Melatonin Viatris
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).

Melatonin Viatris with food, drinks and alcohol
Take Melatonin Viatris after eating. Do not consume alcohol before, during or after taking Melatonin Viatris, as alcohol reduces the effectiveness of Melatonin Viatris.
Pregnancy and breastfeeding
Do not take Melatonin Viatris if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Melatonin Viatris may cause drowsiness. If this occurs, you must not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.
Melatonin Viatris contains lactose monohydrate
Melatonin Viatris 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 Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one Melatonin Viatris tablet (2 mg) taken orally every day after a meal, 1-2 hours before bedtime. This dosage may be maintained for up to thirteen weeks.
The tablet must be swallowed whole. Melatonin Viatris tablets must not be crushed or split.

If you take more Melatonin Viatris than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or pharmacist immediately.
If you have taken a dose higher than the maximum recommended dose, you may experience drowsiness.

If you forget to take Melatonin Viatris
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 the forgotten dose.

If you stop taking Melatonin Viatris
No harmful effects are known to occur if treatment is interrupted or stopped prematurely. No withdrawal symptoms associated with discontinuation of Melatonin Viatris after completion of therapy have been reported.
If you have any doubts about how to use 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 immediately 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
Visual impairment
Blurred vision
Disorientation
Dizziness (sensation of dizziness or "spinning")
Presence of red blood cells in urine
Reduced number of white blood cells in blood
Reduction in platelets, increasing the risk of 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, 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 urine, excess protein in 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 levels of serum calcium in the blood,
low levels of sodium in the blood, mood changes, aggression, agitation, crying, stress symptoms, early
morning awakening, increased libido (increased sexual desire), depressed mood, memory impairment,
attention disorders, dream-like state, restless legs syndrome, poor quality of sleep, sensation of
"pins and needles", watery eyes, postural dizziness (dizziness upon standing or sitting up), hot flushes,
acid reflux, stomach disorders, blisters in the mouth, tongue ulceration, stomach discomfort, vomiting,
abnormal intestinal noises, intestinal gas, excessive saliva production, bad breath, abdominal pain,
stomach disturbances, inflammation of the gastric mucosa, eczema, rash, hand dermatitis, itchy rash,
nail disorders, arthritis, muscle spasms, neck pain, night cramps, prolonged erection which may be
painful, prostate inflammation, tiredness, pain, thirst, increased urine production, nocturia (nighttime
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, contact your doctor or
pharmacist. You may also report side effects directly via the national reporting system at the website
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 Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 medicines 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 Viatris 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 phosphate dibasic dihydrate (E341(ii)), lactose monohydrate, silica (colloidal anhydrous) (E551), talc (E533b) and magnesium stearate (E 470b).

Description of the appearance of Melatonina Viatris and package contents
Melatonina Viatris 2 mg prolonged-release tablets are available as round, biconvex tablets, white to almost white in colour. Each tablet carton contains one blister strip with 21 tablets (pack size: 21 tablets) or two blister strips with 15 tablets each (pack size: 30 tablets).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan SpA
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Laboratorios Rubio S.A.
Calle Industria 29
Polígono Industrial Comte De Sert
Castellbisbal
Barcelona
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Iceland: Melatonin Viatris
Denmark: Melatonin Viatris
France: MELATONINE VIATRIS LP 2 mg, comprimé à libération prolongée
Italy: Melatonina Viatris
Norway: Melatonin Viatris
Portugal: Melatonina Viatris 2 mg Comprimido de libertação prolongada