Mellozzan

Patient Information Leaflet

Mellozzan 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 3 mg tablets, 4 mg tablets, 5 mg tablets

melatonin
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Mellozzan is and what it is used for
2. What you need to know before taking Mellozzan
3. How to take Mellozzan
4. Possible side effects
5. How to store Mellozzan
6. Contents of the pack and other information

1. What Mellozzan is and what it is used for

The active substance in Mellozzan, melatonin, belongs to a group of natural hormones produced by the body. This hormone contributes to the regulation of the sleep-wake rhythm.
Mellozzan is used for:

• short-term treatment of jet lag in adults. Jet lag refers to the collection of symptoms caused by time differences when travelling across multiple time zones;
• insomnia with difficulty falling asleep in children and adolescents (aged between 6 and 17 years) with attention deficit hyperactivity disorder (ADHD), when other healthy sleep practices have not been sufficiently effective.

2. What you need to know before taking Mellozzan

Do not take Mellozzan

• 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 Mellozzan:

• if there are other causes of insomnia;
• if you have diabetes or impaired glucose tolerance, because this medicine may increase blood glucose levels (glycaemia) (see section 3);
• if you have liver or kidney problems;
• if you have an autoimmune disease (i.e. a disease in which the body is "attacked" by its own immune system);
• if you have epilepsy, as melatonin may increase the frequency of convulsive seizures in patients with epilepsy;
• if you are elderly;
• if you are a woman of childbearing age: you must use contraceptive measures during treatment with Mellozzan. However, some contraceptives may affect the levels of this medicine. For further information, see section "Other medicines and Mellozzan".

Smoking
Smoking may reduce the effects of Mellozzan. If you smoke, start smoking, or stop smoking, your doctor may need to adjust your prescribed dose.

Children and adolescents
This medicine must not be used in children or adolescents under 18 years of age for the treatment of jet lag. This medicine must not be used in children under 6 years of age with ADHD.

Other medicines and Mellozzan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

• fluvoxamine (used in the treatment of depression and obsessive-compulsive disorder);
• imipramine (used in the treatment of depression), as taking both medicines together may increase drowsiness and difficulty in performing tasks;
• psoralens (used in the treatment of skin diseases such as psoriasis);
• cimetidine, omeprazole (used in the treatment of stomach problems such as ulcers);
• estrogens (used in contraceptives or hormone replacement therapy);
• ciprofloxacin, norfloxacin and rifampicin (used in the treatment of bacterial infections);
• carbamazepine and phenytoin (used in the treatment of epilepsy);
• medicines for pain and inflammation (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid and ibuprofen);
• benzodiazepines and non-benzodiazepine hypnotics (medicines for insomnia, e.g. midazolam, temazepam, zaleplon, zolpidem, zopiclone), as melatonin may enhance the sedative effect of these medicines and may worsen some of the adverse effects of zolpidem (morning drowsiness, nausea, confusion);
• warfarin and other medicines that thin the blood, e.g. dabigatran, rivaroxaban, apixaban, edoxaban. It may be necessary to monitor the time required for blood to clot, a test also known as INR;
• nifedipine and other beta-blockers (used in the treatment of high blood pressure);
• thioridazine (used in the treatment of mental/mood disorders), as taking both medicines together may increase drowsiness and difficulty in performing tasks;
• caffeine (a stimulant), due to the possibility of interactions with melatonin.

Mellozzan with food and alcohol
Do not eat within 2 hours before and 2 hours after taking Mellozzan. Do not consume alcohol before, during, or after taking Mellozzan, as alcohol may reduce the effectiveness of melatonin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Contraceptive measures for women and girls of childbearing age
Women and girls of childbearing age must use contraceptive measures during treatment. Some contraceptives may affect the levels of Mellozzan (see section "Other medicines and Mellozzan"); discuss your choice of contraceptive method with your doctor.

Pregnancy
Mellozzan is not recommended during pregnancy. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child.

Breastfeeding
Mellozzan is not recommended during breastfeeding. Melatonin is excreted in breast milk and the risk to infants cannot be excluded.

Driving and using machines
Mellozzan may cause drowsiness. If this occurs, you must not drive, ride a bicycle, or operate machinery.

3. How to take Mellozzan

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults with jet lag
The recommended dose is 0.5 to 5 mg. The maximum daily dose is 5 mg once daily, for a
maximum of 5 days. Take the lowest dose that relieves your symptoms for the shortest possible
time, and in any case no longer than 5 days.
Take the dose before the time you should go to sleep according to local time zone when travelling across at least 5 time zones, especially eastbound. The tablets must not be
taken before 8:00 p.m. or after 4:00 a.m.
Children and adolescents aged 6 to 17 years with ADHD and insomnia
The recommended starting dose is 0.5 to 2 mg taken 30–60 minutes before bedtime. If there is no improvement in symptoms, your doctor may increase the dose of Mellozzan to find the most appropriate dose. The maximum daily dose is 5 mg, regardless of age. The lowest possible dose will be prescribed.
Treatment should be periodically reviewed by a doctor to confirm its appropriateness.
Method of administration
Tablet for oral use.
The tablet may be crushed and mixed with water immediately before ingestion.
Do not eat within two hours before and two hours after taking Mellozzan.
Diabetes
If you have diabetes or impaired glucose tolerance, do not eat within two hours before and two hours
after taking Mellozzan.
If you take more Mellozzan than you should
If you or your child has accidentally taken an excessive amount of the medicine, or if, for example,
the medicine has been accidentally ingested by a child, contact a doctor or go to hospital.
Taking a dose higher than the recommended daily dose may cause drowsiness.
If you forget to take Mellozzan
If you forget to take a dose at bedtime and wake up during the night, you may take the missed dose, but not after 4 a.m.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Mellozzan
No harmful effects related to stopping or interrupting treatment prematurely are known. No withdrawal symptoms are known upon discontinuation of treatment with Mellozzan.
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
Mellozzan and contact your doctor immediately:

• Hypersensitivity reaction (allergy-like reactions such as itching, difficulty breathing), swelling of the face, swelling of the mouth, swelling of the tongue
• Chest pain

Other possible side effects:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Drowsiness

Uncommon side effects (may affect up to 1 in 100 people)

• Irritability, nervousness, restlessness, anxiety
• Insomnia, abnormal dreams, nightmares
• Migraine, dizziness, nausea
• Lack of energy, restlessness associated with increased level of activity
• High blood pressure
• Abdominal pain, indigestion, mouth ulcers, dry mouth
• Changes in blood composition that may cause yellowing of the skin and eyes
• Skin inflammation, itching, rash, dry skin, night sweats
• Pain in arms and legs
• Glucose in urine, excess protein in urine
• Menopausal symptoms
• Feeling of weakness
• Weight gain
• Abnormal liver function test

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

• Herpes zoster
• Decreased number of white blood cells in the blood
• Decreased number of platelets in the blood
• Low levels of calcium or sodium in the blood
• High levels of fats in the blood
• Mood alteration, aggression, agitation, crying, stress symptoms, disorientation (feeling confused), early morning awakening, increased sexual desire, depressed mood, depression
• Fainting, memory impairment, attention disorder, dream-like sensation (dream state), restless legs syndrome, poor quality sleep, skin tingling sensation
• Vision impairment, blurred vision, increased tear production
• Vertigo (sensation of dizziness or spinning), dizziness when standing up or sitting down
• Chest pain due to angina pectoris, rapid heartbeat
• Sudden feeling of warmth (hot flush)
• Acid reflux, gastrointestinal disorder, small blisters in the mouth, tongue ulcers, stomach upset, vomiting, abnormal intestinal noises, flatulence, increased saliva production, bad breath, abdominal discomfort, inflammation of the stomach lining
• Eczema, erythema, hand dermatitis, itchy rash, generalized rash, psoriasis, nail problems
• Joint inflammation, muscle spasms, neck pain, night cramps
• Increased urine volume, need to urinate at night, presence of red blood cells in urine
• Prolonged erection, which may be painful, in the absence of sexual stimulation, prostate swelling (prostatitis)
• Tiredness, pain, thirst
• High liver enzyme levels, abnormal blood electrolyte levels, abnormal laboratory test results

Not known (frequency cannot be estimated from the available data)

• Spontaneous milk secretion from the breasts (also in men)
• High blood sugar levels

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide
more information on the safety of this medicine.

5. How to store Mellozzan

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 carton and on the vial after Exp.
The expiry date refers to the last day of that month.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Mellozzan contains

• The active substance is melatonin. One tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg.
• The other excipients are microcrystalline cellulose (E 460), pregelatinized starch (E 1404), colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Description of the appearance of Mellozzan and package contents
Mellozzan 0.5 mg is a white to yellowish, round, biconvex tablet with "0" engraved on one side, 7.5 mm in diameter.
Mellozzan 1 mg is a white to yellowish, round, biconvex tablet with "1" engraved on one side, 9.5 mm in diameter.
Mellozzan 2 mg is a white to yellowish, round, biconvex tablet with "2" engraved on one side, 7.0 mm in diameter.
Mellozzan 3 mg is a white to yellowish, round, biconvex tablet with "3" engraved on one side, 8.0 mm in diameter.
Mellozzan 4 mg is a white to yellowish, round, biconvex tablet with "4" engraved on one side, 9.0 mm in diameter.
Mellozzan 5 mg is a white to yellowish, round, biconvex tablet with "5" engraved on one side, 10.0 mm in diameter.
Mellozzan 0.5 mg and 1 mg tablets are supplied in a plastic bottle with a cap (tamper-evident) containing 100 tablets.
Mellozzan 2 mg, 3 mg, 4 mg, and 5 mg tablets are supplied in a plastic bottle with a cap (tamper-evident) containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Italfarmaco S.p.A.
Viale Fulvio Testi 330,
20126 Milan,
Italy

Manufacturer
EQL Pharma AB
Stortorget 1,
22223 Lund,
Sweden