Patient leaflet - Mellozzan 3 mg tablets

1. What Mellozzan is and what it is used for

The active substance of Mellozzan, melatonin, belongs to a group of natural hormones produced by the body. The hormone helps regulate the body’s day- and night rhythm.

Mellozzan is used for:

Short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling across several time zones.
Insomnia in children and adolescents (6 to 17 years old) with Attention-Deficit Hyperactivity Disorder (ADHD), where other healthy sleeping routines have not worked well enough.

2. What you need to know before you or your child take Mellozzan

Do not take Mellozzan:

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 Mellozzan if you or your child: - have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood.

have liver or kidney problems.
have an autoimmune disease (where the body is ‘attacked’ by its own immune system). - have epilepsy.
or if you are elderly.

Smoking

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

Mellozzan with food and alcohol

Food should not be consumed 2 hours before or 2 hours after intake of Mellozzan tablets. Do not drink alcohol in connection with taking Mellozzan, as it may reduce the effect of melatonin on sleep.

Children and adolescents

Mellozzan should not be given to children below the age of 6 years.

Other medicines and Mellozzan

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

If Mellozzan is taken at the same time as the following medicines, it can affect the way that Mellozzan or the other medicine works:

Depression (e.g. fluvoxamine, citalopram)
Sleep disorder (e.g. zolpidem)
Epilepsy (carbamazepine, phenytoin)
Ulcers (cimetidine, omeprazole, lansoprazole)
Skin disorders (psoralens)
Heart conditions (verapamil)
High blood pressure (nifedipine and other calcium channel blockers, beta blockers) - Bacterial infections (rifampicin, ciprofloxacin and norfloxacin)
Preventive and treatment of blood clots (warfarin)
Contraceptives containing ethinylestradiol and gestagen
Hormone replacement therapy due to menopause problems
Pain and inflammation (non-steroidal anti-inflammatory medicines e.g. acetylsalicylic acid and ibuprofen)

Pregnancy and breast-feeding

If you or your child are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should not use Mellozzan.

Pregnancy

Mellozzan tablets are not recommended if you or your child are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are a woman of childbearing potential you have to use contraception.

Breast-feeding

Mellozzan tablets are not recommended if you or your child are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed child cannot be excluded.

Driving and using machines

Mellozzan can make you feel drowsy. If this happens, you must not drive or operate machinery.

3. How to take Mellozzan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you have impaired kidney function or are elderly, your doctor may need to reduce your dose.

Adults with jet lag

The recommended dose is 0.5 to 5 mg for a maximum of 5 days.

Take the dose at the time of bedtime at the destination, when traveling over at least 5 time zones, especially for trips in easterly direction. The tablets should not be taken before 20:00 hr or after 04:00 hr.

Mellozzan for treatment of jet lag may be taken for a maximum of 16 treatment periods per year.

Children and adolescents aged 6-17 years old with ADHD with insomnia

The recommended starting dose is 0.5 to 2 mg 30 - 60 minutes before bedtime. If there is no improvement in your/your child’s symptoms, your doctor may increase the dose of Mellozzan to find the most suitable dose for you/your child. The maximum daily dose that you/your child will receive is 5 mg.

Treatment should be followed up regularly by a doctor (at least every 6 months is recommended) to see if it is still appropriate. Treatment should be interrupted once a year to see if treatment is still needed.

The tablet can be crushed before intake and mixed with water.

Food should not be consumed 2 hours before or 2 hours after intake of Mellozzan.

If you take more Mellozzan than you should

If you or your child have accidentally taken too much medicine or if for example a child has ingested the medicine by mistake, contact a doctor or pharmacist as soon as possible.

Taking more than the recommended daily dose may make you feel drowsy, dizzy, nauseous and/or have a headache.

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 forgotten dose but at no later than 04:00 hr.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Mellozzan

There are no known harmful effects if treatment is interrupted or ended. The use of Mellozzan is not known to cause any withdrawal effects after treatment completion.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist Created on:

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you or your child experience any of the following serious side effects, stop taking Mellozzan and contact a doctor immediately:

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

Hypersensitivity reaction (allergy like reactions such as itching, difficulty to breathe) - Angioedema with symptoms such as swelling of the face, tongue, or throat; difficulty swallowing, hives and difficulty breathing.

Rare side effects (may affect up to 1 to 1000 people)

Chest pain due to angina pectoris.

Other possible side effects

Common side effects (may affect up to 1 to 10 people)

Headache
Sleepiness.

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

Irritability, nervousness, restlessness, anxiety
Insomnia, abnormal dreams, nightmares, night sweats
Migraine, dizziness, nausea
Tiredness (and lack of energy), restlessness associated with increased activity - High blood pressure
Abdominal pain, upper abdominal pain, indigestion
Mouth ulcers, dry mouth
Changes in the composition of your blood which can cause yellowing of the skin and eyes - Skin problems (dermatitis, itching, rash, general itching, dry skin)
Pain in arms and legs
Excretion of glucose in the urine, too much protein in the urine
Menopausal symptoms
Feeling of weakness, chest pain
Liver test abnormalities
Weight gain.

Rare side effects (may affect up to 1 in 1000 people)

Shingles (herpes zoster)
Reduced number of white blood cells in the blood
Reduced number of platelets in the blood
Low levels of calcium or sodium in the blood
High levels of fats in the blood
Altered mood, aggression, restlessness, crying, stress symptoms, feeling confused (disoriented), early morning awakening, increased sex drive (increased libido), depressed mood, depression - Fainting, memory impairment, attention disorder, dreamy state, unpleasant feeling in the legs (restless legs syndrome), poor sleep quality, “pins and needles” feeling (paresthesia) - Impaired visual acuity, blurred vision, watery eyes
A feeling of dizziness or “spinning” (vertigo), dizziness when getting up or sitting down - Feeling your heartbeat
Hot flushes
Acid reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, gastrointestinal upset, vomiting, abnormal bowel sounds, wind (flatulence), increased salivation, bad breath, abdominal discomfort, gastric disorder, inflammation of the gastric mucosa - Skin problems (eczema, redness, hand dermatitis, psoriasis, rash generalized, itchy rash, nail disorders
Joint inflammation (arthritis), muscle cramps, neck pain, night cramps
Increased amounts of urine, red blood cells in the urine, urination at night - Prolonged erection – that might be painful – without sexual stimulation, inflammation or swelling of the prostate
Tiredness, pain, thirst
Increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.

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

High blood sugar level
Abnormal milk secretion.

Reporting of side effects

If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you 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 label after EXP. The expiry date refers to the last day of that month.

Store in original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mellozzan contains

The active substance is melatonin 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. - The other excipients are microcrystallized cellulose, pregelatinized starch, colloidal anhydrous silica and magnesium stearate

What Mellozzan looks like and contents of the pack

Mellozzan 0.5 mg is a white to yellowish, round tablet with “0” marked on one side; tablet size 7.5 mm. Mellozzan 1 mg is a white to yellowish, round tablet with “1” marked on one side, tablet size 9.5 mm. Mellozzan 2 mg is a white to yellowish, round tablet with “2” marked on one side, tablet size 7.0 mm. Mellozzan 3 mg is a white to yellowish, round tablet with “3” marked on one side, tablet size 8.0 mm. Mellozzan 4 mg is a white to yellowish, round tablet with “4” marked on one side, tablet size 9.0 mm. Mellozzan 5 mg is a white to yellowish, round tablet with “5” marked on one side, tablet size 10.0 mm.

Mellozzan is available in bottle packs of 30, 60 or 100 tablets and in blister packs with 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Manufacturer

EQL Pharma AB

Stortorget 1

222 23 Lund

Sweden

This leaflet was last revised in May 2026.

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