Melatonite 3 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Melatonite 3 mg film-coated tablets

melatonin

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as provided 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 any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of the leaflet:

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

1. What Melatonite is and what it is 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 mood disturbances, irritability, and gastrointestinal disturbances experienced after flying.

How Melatonite works
Melatonin is a hormone produced by the body that synchronizes the daily biological rhythm. The biological rhythm may be disrupted when travelling across different time zones. This is known as jet lag. Symptoms and their severity vary from person to person, but are generally worse and last longer the more time zones crossed. This medicine may help restore the normal day-night rhythm and reduce symptoms.

You should consult a doctor if you worsen or do 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• if you have epileptic seizures. Melatonin may increase the frequency of seizures in patients with epilepsy.
• if you have an autoimmune disease (a condition in which the body is “attacked” by its own immune system).
• if you have diabetes or impaired glucose tolerance, as this medicine may increase blood glucose concentration. Make sure not to 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 severe liver problems or significant kidney problems.
• if you smoke. Smoking may reduce the effect of this medicine, as components of tobacco smoke can 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 lower blood pressure.
• This medicine may cause drowsiness. You should be cautious 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 aged 0 to 18 years, as its safety and efficacy for 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 need to 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, zaleplon, zolpidem, zopiclone), as melatonin may enhance the sedative effect of these medicines and potentiate certain side effects of zolpidem (morning drowsiness, nausea, confusion).

Taking Melatonite with food and alcohol

• This medicine should not be taken with food (see section 3).
• As alcohol may disrupt sleep and potentially worsen certain symptoms of jet-lag (e.g., headache, morning fatigue, lack of concentration), alcohol consumption is not recommended while taking this medicine.
• Drinking alcohol while taking this medicine may increase drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, 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 insufficient information on the potential risk 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 a risk to the breastfed infant or child cannot be ruled out.

Fertility

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

Driving and use of machines

Melatonin may cause drowsiness and may reduce alertness for several hours after intake. Therefore, this medicine should not be taken before driving or operating machinery.

Melatonite contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; i.e., it is essentially “sodium-free”.

3. How to take Melatonite

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

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

The first dose should be taken upon arrival at your destination, at your usual bedtime. Subsequent doses should also be taken at your usual bedtime. Tablets must not be taken before 8:00 p.m. or after 4:00 a.m.

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

This medicine may be taken for up to 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 Toxicology Information Service at telephone number 915620420, stating 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 may take the missed dose, but not later than 4:00 a.m.

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

If you stop taking Melatonite

If you discontinue treatment with this medicine, there will be no harmful effects or withdrawal symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

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

• Chest pain.

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

• Decrease in the number of white blood cells in the blood
• Decrease in the number of platelets, which increases the risk of bleeding or bruising
• Disorientation
• Fainting
• Visual disturbances, including blurred vision
• Awareness of heartbeat (palpitations)
• Blood (red blood cells) in the urine.

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

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

Other adverse effects

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

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Drowsiness.

Uncommon adverse 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 urine, excess protein in urine
• Feeling unwell
• Weight gain.

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

• Elevated levels of certain fat molecules (triglycerides) in the blood
• Mood disturbances, aggression, increased sex drive
• Memory impairment, restless legs syndrome, tingling sensation
• Watery eyes
• Hot flushes
• Vomiting, flatulence, excessive salivation, bad breath, inflammation of the stomach mucosa
• Nail abnormalities
• Arthritis, muscle spasms
• Increased urine volume
• Prolonged erection which may be painful, enlargement of the prostate gland
• Thirst
• Abnormal blood electrolyte levels.

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage temperature.
• This medicine should be kept in its original packaging to protect it from light.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Pack contents and additional information

Composition of Melatonite

• The active substance is melatonin. Each tablet contains 3 mg 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 pack contents

Round, biconvex film-coated tablet, transparent, white to almost white. Size: 7.5 mm in diameter.

Blister packs of 10 or 30 film-coated tablets in cardboard boxes. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharma Nord Aps

Tinglykke 4-6

6500 Vojens

Denmark

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

Date of the last revision of this leaflet: May 2023.

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