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

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. The hormone helps to 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 over several time zones.
  • insomnia in children and adolescents 6 – 17 years with ADHD where other sleep support measures are not sufficient.

Melatonin contained in Mellozzan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Mellozzan

Do not use 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 cautions

Talk to your doctor, pharmacist, or nurse before taking Mellozzan if you have:

  • diabetes or impaired glucose tolerance, as this medicine may increase blood sugar levels
  • liver or kidney problems
  • an autoimmune disease (when the body is “attacked” by its own immune system)
  • epilepsy . Melatonin may affect the frequency of seizures in patients with epilepsy .
  • or if you are older
  • Fertile women should use contraception during treatment with Mellozzan, see “Pregnancy, breast-feeding and fertility” for more information.

Smoking

Smoking can cause Mellozzan to have a worse effect. If you smoke, start or stop smoking, your doctor may need to adjust your dose.

Children and young people

Mellon is not intended for children under 6 years of age.

Other medicines and Mellozzan

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

Mellozzan can affect or be affected if taken at the same time as certain other medicines for:

  • Depression (eg fluvoxamine, citalopram )
  • Difficulty sleeping (eg zolpidem)
  • Epilepsy (carbamazepine, phenytoin )
  • Gastric ulcer (cimetidine, omeprazole, lansoprazole)
  • Skin diseases such as psoriasis (psoralenes)
  • Heart disease (verapamil)
  • High blood pressure (nifedipine, beta-blocker )
  • Bacterial infections ( ciprofloxacin , norfloxacin)
  • Tuberculosis (rifampicin)
  • Prevention and treatment of blood clots ( warfarin )
  • Contraceptives containing estrogen
  • Hormone therapy due to menopausal symptoms
  • Pain and inflammation (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid and ibuprofen )
  • Fatigue (caffeine)

Mellozzan with food, drink and alcohol

Do not drink alcohol while taking Mellozzan, as it may reduce the effect of melatonin on sleep.

Effect melatonin can be affected if taken at the same time as caffeine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, do not use Mellozzan.

Contraceptives for fertile women and young women

Women of childbearing potential should use contraceptives during treatment. However, Mellozzan may be affected by certain contraceptives (see “Other medicines and Mellozzan”), discuss the choice of contraceptive with a doctor.

Pregnancy

Mellozzan is not recommended if you or your baby are pregnant. Melatonin passes through the placenta and there is insufficient information about the risk this may pose to the unborn baby.

Breast-feeding

Mellozzan is not recommended if you are breastfeeding. Melatonin is excreted in breast milk and it can not be ruled out that there is a risk to the breast-fed baby.

Fertility

Mellozzan is not recommended for women and men who are planning to have children as there is insufficient information on the effects of melatonin on female and male fertility.

Driving and using machines

Mellozzan can make you drowsy. If this happens, do not drive, cycle or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Mellozzan

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

If you have impaired kidney function or are older, your doctor may need to adjust your dose downwards.

Adults with jet lag

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

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

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

Children and adolescents 6-17 years with ADHD with insomnia

The recommended starting dose is 0.5 to 2 mg 30 – 60 minutes before bedtime. If no improvement is seen in your / your child’s symptoms, your doctor may increase the dose one of Mellozzan to find the most appropriate 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 recommended) to see if it is still appropriate. Treatment breaks should be made once a year to see if treatment is still needed.

The tablet can be crushed in connection with ingestion and mixed with water.

Diabetes

If you or your child have diabetes or impaired glucose tolerance, no food should be taken 2 hours before or after taking Mellozzan (see “Warnings and Precautions”).

Possible side effects

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

If you get any of these serious side effects, stop taking Mellozzan immediately and see a doctor:

Other possible side effects are

Common side effects: may affect up to 1 in 10 people

  • Headache
  • Somnolence

Uncommon side effects: may affect up to 1 in 100 people

  • Irritability, nervousness, anxiety
  • Insomnia, abnormal daydreams, nightmares
  • Migraine , dizziness, nausea
  • Drowsiness and lack of energy, restlessness associated with increased activity
  • High blood pressure
  • Abdominal pain, stomach upset, mouth sores, dry mouth
  • Changes in the composition of the blood that can cause yellowing of the skin and eyes
  • Inflammation of the skin, itching , rash, dry skin, night sweats
  • Pain in arms and legs
  • Excretion of glucose in the urine, too much protein in the urine
  • Menopausal symptoms in women
  • Feeling of weakness, chest pain
  • Weight gain

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

  • Shingles
  • 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
  • Changed mood, aggression, weeping, stress symptoms, difficulty orienting oneself, waking up early in the morning, increased sexual drive, depression,
  • Fainting, memory loss, attention deficit disorder, dreaming state, restless legs syndrome, poor sleep quality, skin sensations
  • Impaired visual acuity , blurred vision, increased tear flow
  • Dizziness, positional dizziness (dizziness when getting up or sitting down)
  • Chest pain due to angina, palpitations
  • Hemorrhoids
  • Acid reflux, gastrointestinal upset, blisters in the mouth, sores on the tongue, stomach upset, vomiting, abnormal bowel sounds, gas formation, increased salivation, bad breath, inflammation of the gastric mucosa
  • Eczema , skin rash, inflammation of the hands on the hands, itchy rash, psoriasis , nail disorders
  • Arthritis, muscle cramps, neck pain, nocturnal cramps
  • Increased amounts of urine, urination at night, red blood cells in the urine
  • Prolonged erection – which can be painful – unrelated to sexual stimulation, inflammation of the prostate
  • Fatigue, pain, thirst
  • Elevated liver enzyme levels, abnormal salinity and abnormal laboratory tests

Adverse reactions that have been reported: occur in an unknown number of users

  • Abnormal secretion of breast milk
  • Hallucinations (sensory disturbances, for example, seeing, feeling or hearing something that does not exist)
  • High blood sugar level

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

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 can after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is melatonin . 1 tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg melatonin .

The other ingredients are cellulose, microcrystalline (E 460); pregelatinized starch (E 1404); silica, colloidal, anhydrous (E 551); magnesium stearate (E 470b).

What the medicine looks like and contents of the pack

Mellozzan 0.5 mg is a white to slightly yellowish, round tablet with an imprint “0” on one side, tablet size 7.5 mm.

Mellozzan 1 mg is a white to slightly yellowish, round tablet with imprint “1” on one side, tablet size 9.5 mm.

Mellozzan 2 mg is a white to slightly yellowish, round tablet with imprint “2” on one side, tablet size 7.0 mm.

Mellozzan 3 mg is a white to slightly yellowish, round tablet with imprint “3” on one side, tablet size 8.0 mm.

Mellozzan 4 mg is a white to slightly yellowish, round tablet with imprint “4” on one side, tablet size 9.0 mm.

Mellozzan 5 mg is a white to slightly yellowish, round tablet with imprint “5” on one side, tablet size 10.0 mm.

Mellozzan is available in a plastic jar with a lid (with a safety seal), containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

EQL Pharma AB

Stortorget 1

222 23 Lund

Muhammad Nadeem

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