Leaflet: information for the user

Melatonite 3 mg film-coated tablets

melatonin

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for this medicine contained in this leaflet or indicated by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-For advice on any aspect of your dose, including has-side effect reporting, contact your pharmacist.

-Report any side effects you experience to your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

-You must see a doctor if your symptoms worsen or do not improve after 5days.

1.What Melatonite is and what it is used for

2.What you need to know before you start taking Melatonite

3.How to take Melatonite

4.Possible side effects

5.Storage of Melatonite

6.Contents of the pack and additional information

Melatonite contains the active ingredient melatonin. This medication may be used to alleviate short-term symptoms ofjet lagin adults. Time zone displacement (jet lag) can be recognized by sleep disturbances, daytime fatigue, fatigue, mild mental problems, irritability, and gastrointestinal alterations experienced after flying.

How Melatonite worksMelatonin is a hormone produced by the body that synchronizes the diurnal and nocturnal biological rhythm. The biological rhythm may be altered if traveling across different time zones. This is known as time zone displacement (jet lag). Symptoms and their severity vary from person to person, but generally, they are worse and last longer the more time zones crossed. This medication may help restore the normal day and night rhythm and reduce symptoms.

You should consult a doctor if symptoms worsen or do not improve after 5days.

Do not take Melatonite

•if you are allergic to melatonin or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

•if you have seizures. Melatonin may increase the frequency of seizures in patients with epilepsy.

•if you have an autoimmune disease (in which your body is "attacked" by your own immune system).

•if you have diabetes or impaired glucose tolerance, as this medication may increase blood glucose concentration. Make sure not to take this medication 2hours before a meal and wait at least 3hours after a meal if you have diabetes.

•if you have moderate to significant liver problems or significant kidney problems.

•if you smoke. Smoking may reduce the effect of this medication as the components of tobacco smoke may increase the breakdown of melatonin in the liver.

•if you have hypertension and are being treated for it. Melatonin may counteract the beneficial effects of medications that reduce blood pressure.

•This medication may cause drowsiness. You should be careful if drowsiness affects you, as it may impair your ability to perform tasks such as driving.

Children and adolescents

Do not administer this medication to children and adolescents between 0 and 18 years of age as its safety and efficacy in the short-term treatment ofjet-lagare not known.

Other medications and Melatonite

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

•Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin.

•Psoralen (used for the treatment of skin disorders, e.g., psoriasis), as psoralen may increase the effect of melatonin.

•Cimetidine (used for the treatment of stomach problems such as ulcers), as cimetidine may increase the effect of melatonin.

•Estrogens (used in contraceptives or hormone replacement therapy), as estrogens may increase the effect of melatonin.

•Quinolones (used in the treatment of bacterial infections), as quinolones may increase the effect of melatonin.

•Rifampicin (used in the treatment of bacterial infections), as rifampicin may decrease the effect of melatonin.

•Carbamazepine (used in the treatment of epilepsy), as carbamazepine may decrease the effect of melatonin.

•Warfarin (used as an anticoagulant), as melatonin may interfere with the effect of warfarin.

•Benzodiazepines and non-benzodiazepine hypnotics (medications used to induce sleep, e.g., midazolam, temazepam, and zaleplon, zolpidem, zopiclone), as melatonin may increase the sedative effect of these medications and potentiate certain side effects of zolpidem (morning drowsiness, nausea, confusion).

Taking Melatonite with food and alcohol

•This medication should not be taken with food (see section3).

•As alcohol may alter sleep and potentially worsen certain symptoms ofjet-lag(e.g., headache, morning fatigue, lack of concentration), it is recommended not to consume alcohol while taking this medication.

•The consumption of alcohol while taking this medication may cause an increase in drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication is not recommended if you are pregnant. Melatonin crosses the placenta and there is not enough information about the risk this may pose to the fetus.Women of childbearing age should use contraceptive methods.

Breastfeeding

Melatonin is not recommended if you are breastfeeding. Melatonin passes into breast milk, and it cannot be ruled out that there may be a risk to the infant or the baby being breastfed.

Fertility

Melatonin is not recommended for women and men planning to have a baby as there is not enough information about the effects of melatonin on female and male fertility.

Driving and operating machinery

Melatonin may cause drowsiness and may decrease alertness for several hours after ingestion. Therefore, this medication should not be taken before driving or operating machinery.

Melatonite contains sodium

This medication contains less than 1mmol of sodium (23mg) per coated tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions for this medication described in this leaflet or indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose for adults and elderly patients is 1tablet daily for a maximum of 5days. If the effect of this medication is inadequate,two tablets may be taken simultaneously the following night.The dose that reduces symptoms sufficiently should be taken for the shortest possible period.

The first dose should be taken upon arrival at the destination at the usual bedtime hour. The dose should also be taken at the usual bedtime hour in the following days.Tablets should not be taken before 8:00 PM or after 4:00 AM.

Tablets should be swallowed whole with water or another liquid (e.g., milk, fruit juice). Food should not be consumed at least 2 hours before or at least 2 hours after taking this medication.If you have glucose intolerance or diabetes, it is best not to take Melatonite at least 3hours after a meal.

This medication may be taken for a maximum of 16periods of treatment per year.

If you take more Melatonite than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.

If you forget to take Melatonite

If you forget to take the tablets at bedtime and wake up during the night, you may take the missed dose but no later than 4:00 AM.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Melatonite

If you interrupt treatment with this medication, it will have no adverse effects or withdrawal symptoms.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

If you experience any of the following severe side effects, stop taking this medicine and contact your doctor immediately:

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

-Chest pain.

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

-Decreased white blood cell count in the blood

-Decreased platelet count, increasing the risk of bleeding or bruising

-Disorientation

-Fainting

-Visual impairment, including blurred vision

-Perception of heartbeats ("palpitations")

-Blood (red blood cells) in the urine.

Unknown frequency(the frequency cannot be estimated from available data)

-Severe allergic reaction causing inflammation of the tongue or mucous membrane of the mouth.

Other side effects

If you experience any of the following non-serious side effects, contact your doctor or pharmacist:

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, abnormal dreams, anxiety

-Dizziness

-High blood pressure

-Abdominal pain, upper abdominal pain, indigestion, mouth ulcers, dry mouth, nausea

-Itching, skin rash, dry skin

-Glucose excretion in the urine, excess protein in the urine

-Feeling unwell

-Weight gain.

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

-Elevated concentrations of certain fatty molecules (triglycerides) in the blood

-Mood alteration, aggression, increased libido

-Memory impairment, restless legs syndrome, sensation of tingling

-Runny eyes

-Hot flashes

-Vomiting, gas, excess saliva, bad breath, inflammation of the stomach mucosa

-Nail alterations

-Arthritis, muscle spasms

-Increased urine volume

-Prolonged erection that may be painful, inflammation of the prostate gland

-Thirst

-Abnormal concentrations of electrolytes in the blood.

Unknown frequency(the frequency cannot be estimated from available data)

-Hypersensitivity reactions

-High blood glucose concentrations

-Milk secretion from the breasts (also in men).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

•Keep this medication out of the sight and reach of children.

•Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

•This medication does not require any special storage temperature.

•This medication should be stored in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Melatonite

-The active ingredient is melatonin. Each tablet contains 3mg of melatonin.

-The other components are:Tablet core:magnesium stearate, anhydrous colloidal silica, maltodextrin, microcrystalline cellulose, sodium carmellose.Coating: hypromellose.

Appearance of the product and contents of the package

Round, biconvex tablet with transparent coating, white to off-white in color. Diameter 7.5mm.

Packages of 10 or 30coated tablets in blister pack, in cardboard box.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Pharma Nord Aps

Tinglykke 4-6

6500 Vojens

Demark

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:May 2023.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/