3 mg tablets
melatonin

What Melatan is and what it is used for

Melatan contains the active substance melatonin, which belongs to a group of natural hormones produced by the body.

Melatonin helps regulate the body’s day and night rhythm.

Melatan is used in the short-term treatment of jet lag in adults from 18 years. Jet lag refers to the symptoms such as difficulty sleeping, which are caused by the time difference when passing several time zones when traveling east or west.

Melatan is recommended for adults who fly over at least 5 time zones, especially to the east, and especially if they have experienced symptoms of jet lag in connection with previous trips. If necessary, it can also be used by travelers passing 2-4 time zones.

This medicine is for short-term use only for the treatment of jet lag. Contact a doctor if you have other sleep problems that are not caused by jet lag.

Melatonin contained in Melatan may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 using Melatan

Do not take Melatan

– 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 or pharmacist before taking Melatan, if you have:

– epilepsy

– kidney disease

– liver disease

– diabetes or impaired glucose tolerance, as this drug may increase blood sugar levels autoimmune disease (where the body is “attacked” by its immune system).

The use of Melatan is not recommended if you have liver disease, kidney disease, autoimmune disease any of the above diseases.

Smoking can have a worse effect on Melatan, as the ingredients in tobacco smoke can increase the breakdown of melatonin in the liver.

Women of childbearing potential should use contraception during treatment. Melatan can, however, be affected by certain contraceptives, see the section “Other medicines and Melatan” for information on concomitant use with other medicines (including certain contraceptives), and for further information consult a doctor.

Children and young people

Do not give this medicine to children under 18 years of age.

Other medicines and Melatan

Talk to your doctor or pharmacist before using Melatan if you are taking, have recently taken, or might take any other medicines (including medicines obtained without a prescription). This includes the following drugs:

  • warfarin (used to prevent blood clots) – INR (coagulation test) may be needed for closer monitoring.
  • fluvoxamine (used to treat depression and obsessive-compulsive disorder)
  • quinolones and rifampicin (used to treat bacterial infections)
  • estrogen er (used in contraception or hormone replacement therapy)
  • carbamazepine (used to treat epilepsy )
  • 5- or 8-methoxypsoralene (5- and 8-MOP) (used to treat skin conditions such as psoriasis )
  • adrenergic agonists / antagonists (such as certain types of medicines used to control blood pressure by narrowing blood vessels, nasal decongestants, blood pressure lowering medicines)
  • opiate agonists / antagonists (such as medicines used to treat drug addiction)
  • so-called NSAIDs used for pain, fever and inflammation (non-steroidal anti-inflammatory drugs)
  • antidepressants
  • tryptophan (an amino acid that is used in medicines given to patients who need nutritional supplements
  • benzodiazepines and non-benzodiazepine-type sleeping pills (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone )
  • thioridazine (used to treat schizophrenia)
  • imipramine (for the treatment of depression)

Melatan with food, drink and alcohol

Food can affect the effectiveness of Melatan. This medicine should not be taken while eating. Do not eat food for 2 hours before or 2 hours after the planned intake of melatonin.

Do not drink alcohol before, during, or after taking Melatan as it reduces the effectiveness of Melatan.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Should not be taken during pregnancy and lactation. Women of childbearing potential should use contraception during treatment. However, melatan may be affected by certain contraceptives, see the section “Other medicines and Melatan” for information on concomitant use with other medicines (including certain contraceptives), and for further information consult a doctor.

Driving and using machines

Since Melatan can cause i.a. drowsiness, wakefulness can be affected for several hours after taking melatonin. Do not drive or use machines after taking melatonin. 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 take Melatan

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

Jet lag in adults

The recommended dose is a 3 mg tablet per day taken at bedtime local time. Treatment begins on arrival at the destination and is used for a maximum of 4 days.

A maximum daily dose is 3 mg.

Melatan is recommended when traveling over at least 5 time zones, especially when traveling east. If necessary, it can also be used by travelers passing 2-4 time zones. The timing of melatonin intake is important. Dose one should be taken at bedtime (local time).

This medicine should not be taken while eating. Do not eat food for 2 hours before or 2 hours after the planned intake of melatonin. The tablets should be swallowed with a glass of water.

Contact a doctor if the symptoms do not worsen or if they worsen.

Possible side effects

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

Possible side effects are headache, nausea, loss of appetite, dizziness, drowsiness during the day, and disorientation. For other side effects that may occur, see the information below.

When other medicines containing melatonin have been used for various sleep disorders, melatonin has been reported to cause various side effects.

If you get any of the following serious side effects, stop taking the medicine immediately and contact your doctor.

Uncommon : (may affect up to 1 in 100 people)

  • Chest pain

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

  • unconsciousness or fainting
  • severe chest pain due to angina
  • palpitation
  • dizziness (a feeling of dizziness or that it “spins”)

Has been reported : (occurs in an unknown number of people)

  • hypersensitivity reaction
  • swelling of the mouth or tongue

If you get any of the following side effects, 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, migraines, headaches, lethargy (fatigue and lack of energy), restlessness and physical overactivity, dizziness, fatigue, high blood pressure, abdominal pain, indigestion, sore mouth, sore mouth, changes in blood composition that may cause yellowing of the skin and eyes, dermatitis, night sweats, itching, rash, dry skin, pain in the arms and legs, excretion of glucose in the urine, increased protein content in the urine, menopausal symptoms, weakness, abnormal liver function, and weight gain.

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

Shingles , high blood fats, depression, mood swings, aggression, agitation , crying mildness, stress symptoms, waking up early in the morning, increased sexual drive, depression, disorientation, memory loss, attention deficit disorder, drowsiness, restless sleep syndrome, sleep deprivation, numbness and tingling, visual disturbances, watery eyes, dizziness when standing or sitting, hot flashes, acid regurgitation, stomach upset, blisters in the mouth, sores on the tongue, stomach upset, vomiting, abnormal bowel sounds, flatulence, increased salivation, bad breath, abdominal discomfort, gastrointestinal disease, inflammation of the gastric mucosa, psoriasis , eczema, skin rash, inflammation of the hands on the hands, itchy rash, nail disorder, joint inflammation, muscle cramps, neck pain, nocturnal muscle cramps, blood in the urine, abundant excretion of urine, increased need to urinate at night, prolonged erection which can be painful, inflammation of the prostate , fatigue, pain, thirst, decreased number of white blood cells , decreased number of platelets , which increases the risk of bleeding or bruising, elevated liver enzyme values, abnormal blood electrolytes and abnormal results in laboratory tests.

Has been reported : (occurs in an unknown number of people)

Swelling of the skin and abnormal secretion of milk

How to store Melatan

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 label (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.

One 3 mg tablet contains 3 mg of melatonin.

Other ingredients are:

calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, pregelatinized starch.

What the medicine looks like and contents of the pack

3 mg: a white, round, convex tablet with the label “7”, diameter 7 mm.

10 tablets in blister packs (PVC / Aluminum).

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Evolan Pharma AB
PO Box 120
182 12 Danderyd

Manufacturer

Vitabalans Oy

Varastokatu 7-9

135 00 Hämeenlinna

Finland

Muhammad Nadeem

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