MELATONITE 3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Melatonite 3 mg Film-Coated Tablets

melatonin

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet:

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

1. What is Melatonite and what is it used for

Melatonite contains the active substance melatonin. This medicine can be used to relieve short-term symptoms of jet-lag in adults. Jet-lag can be recognized by sleep disturbances, daytime tiredness, fatigue, mild mental problems, irritability, and digestive problems experienced after flying.

How Melatonite worksMelatonin is a hormone produced by the body that synchronizes the daily and nightly biological rhythm. The biological rhythm can be disrupted if you travel across different time zones. This is known as jet-lag. The symptoms and their severity vary from person to person, but they are usually worse and last longer the more time zones you cross. This medicine can help restore the normal day and night rhythm and reduce symptoms.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Melatonite

Do not take Melatonite

• if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• if you have epilepsy. Melatonin may increase the frequency of seizures in patients with epilepsy.
• if you have an autoimmune disease (where the body is "attacked" by its own immune system).
• if you have diabetes or impaired glucose tolerance, as this medicine may increase blood glucose levels. Make sure you do not take this medicine 2 hours before a meal and wait at least 3 hours 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 medicine, as tobacco smoke components may increase the breakdown of melatonin in the liver.
• if you have high blood pressure and are being treated for it. Melatonin may counteract the beneficial effects of blood pressure-lowering medicines.
• This medicine 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 give this medicine to children and adolescents between 0 and 18 years of age, as its safety and efficacy in the short-term treatment of jet-lag have not been established.

Other medicines and Melatonite

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

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin.
• Psoralen (used to treat skin disorders, e.g., psoriasis), as psoralen may increase the effect of melatonin.
• Cimetidine (used to treat 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 to treat bacterial infections), as quinolones may increase the effect of melatonin.
• Rifampicin (used to treat bacterial infections), as rifampicin may decrease the effect of melatonin.
• Carbamazepine (used to treat 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 (medicines used to induce sleep, e.g., midazolam, temazepam, and zaleplon, zolpidem, zopiclone), as melatonin may increase the sedative effect of these medicines and potentiate certain side effects of zolpidem (morning somnolence, nausea, confusion).

Taking Melatonite with food and alcohol

• This medicine should not be taken with food (see section 3).
• As alcohol may alter sleep and potentially worsen certain symptoms of jet-lag (e.g., headache, morning fatigue, lack of concentration), it is recommended not to consume alcohol while taking this medicine.
• Consuming alcohol while taking this medicine may cause increased drowsiness.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medicine is not recommended if you are pregnant. Melatonin crosses the placenta, and there is not enough information on the risk this may pose to the fetus. If you are a woman of childbearing age, you should use contraceptive methods.

Breastfeeding

Melatonin is not recommended if you are breastfeeding. Melatonin passes into breast milk, and a risk to the breastfed child cannot be excluded.

Fertility

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

Driving and using machines

Melatonin may cause drowsiness and may decrease alertness for several hours after intake. Therefore, this medicine should not be taken before driving or using machines.

Melatonite contains sodium

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

3. How to take Melatonite

Follow exactly the administration instructions of this medicine described in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose for adults and elderly patients is 1 tablet daily for a maximum of 5 days. When the effect of this medicine is inadequate, 2 tablets can be taken simultaneously the following night. The dose that sufficiently reduces symptoms should be taken for the shortest possible period.

The first dose should be taken upon arrival at the destination at the usual bedtime. Intake on subsequent days should also be at the usual bedtime. The tablets should not be taken before 8:00 PM or after 4:00 AM.

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

This medicine can be taken for a maximum of 16 treatment periods 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 medicine 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 tablet at bedtime and wake up during the night, you can take the missed dose but no later than 4:00 AM.

Do not take a double dose to make up for missed doses.

If you stop taking Melatonite

If you stop taking this medicine, it will not have any harmful effects or withdrawal symptoms.

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

4. Possible side effects

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

Serious side effects

If you experience any of the following serious 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 number of white blood cells in the blood
• Decreased number of platelets, which increases the risk of bleeding or bruising
• Disorientation
• Fainting
• Visual impairment, including blurred vision
• Palpitations
• Blood in the urine.

Frequency not known(frequency cannot be estimated from the available data)

• Severe allergic reaction causing inflammation of the tongue or mouth mucosa.

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 ulceration, dry mouth, nausea
• Itching, rash, dry skin
• Glucose 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 levels of certain fat molecules (triglycerides) in the blood
• Mood changes, aggression, increased sexual desire
• Memory impairment, restless legs syndrome, tingling sensation
• Tearing
• Hot flushes
• Vomiting, gas, excess saliva, bad breath, stomach mucosa inflammation
• Nail disorders
• Arthritis, muscle spasms
• Increased urine volume
• Prolonged erection that can be painful, prostate gland inflammation
• Thirst
• Abnormal levels of electrolytes in the blood.

Frequency not known(frequency cannot be estimated from the available data)

• Hypersensitivity reactions
• High blood glucose levels
• Milk secretion from the breasts (also in men).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonite

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.
• This medicine does not require any special storage temperature.
• This medicine should be stored in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you have any further questions on the use of this medicine, ask your pharmacist.

6. Contents of the pack and further information

Composition of Melatonite

• The active substance is melatonin. Each tablet contains 3 mg of melatonin.
• The other ingredients are: Tablet core: magnesium stearate, anhydrous colloidal silica, maltodextrin, microcrystalline cellulose, sodium carmellose. Coating: hypromellose.

Appearance of the product and pack contents

Round, biconvex, film-coated tablet, white to off-white in color. Diameter 7.5 mm.

Packs of 10 or 30 film-coated tablets in blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharma Nord Aps

Tinglykke 4-6

6500 Vojens

Denmark

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: May 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/