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MELATONITE 3 mg FILM-COATED TABLETS

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About the medicine

How to use MELATONITE 3 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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:

Belgium

Melatonine Pharma Nord 3 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Estonia

Melatoniin Pharma Nord 3 mg õhukese polümeerikattega tabletid

Hungary

Melatonin Pharma Nord 3 mg filmtabletta

Ireland

Melatonin Pharma Nord 3 mg film-coated tablets

Latvia

Melatonin Pharma Nord 3 mg apvalkotas tabletes

Lithuania

Melatoninas Pharma Nord 3 mg plevele dengtos tabletes

Netherlands

Melatonine Pharma Nord 3 mg filmomhulde tablet

Poland

Melatonina Pharma Nord 3 mg tabletki powlekane

Portugal

Melatonite

Spain

Melatonite 3 mg comprimidos recubiertos con película

United Kingdom (NI)

Melatonin Pharma Nord 3 mg film-coated tablets

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/

Online doctors for MELATONITE 3 mg FILM-COATED TABLETS

Discuss questions about MELATONITE 3 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Pedro Alvarez Guerrero

Psychiatry 8 years exp.

Dr. Alvarez Guerrero graduated in Medicine from the San Pablo CEU University in Madrid. He subsequently completed his specialization in Psychiatry in the Department of Psychiatry at Hospital Sant Joan de Deu in Manresa (Barcelona), where over the course of four years he acquired solid training in the bio-psycho-social model, developing his expertise across the different areas of mental health.

During his residency, he undertook training placements at Hospital Clínic de Barcelona, where he trained for several months in the psychiatric consultation-liaison unit. He also completed another placement at Hospital de Cruces in Bilbao, in the first-episode psychosis unit.

Throughout his professional career, Dr. Alvarez Guerrero has sought to complement his medical training with psychotherapeutic tools that allow him to address mental health disorders from a comprehensive perspective. For this reason, he specialized in Brief Strategic Psychotherapy through the Spanish Society of Psychosomatic Medicine and Psychotherapy, an approach focused on targeted and effective interventions.

With the aim of deepening his knowledge and promoting the rational use of treatments, he also completed a Master’s Degree in Psychopharmacology at the University of Valencia, which has enabled him to rigorously integrate the most up-to-date scientific evidence into the clinical management of psychopharmacological treatments.

He has also shown a particular interest in the field of legal psychiatry, completing an Official Master’s Degree in Legal, Forensic and Criminological Psychopathology at the Universitat Internacional de Catalunya. This training has allowed him to acquire the necessary competencies for the preparation of psychiatric expert reports in judicial and medico-legal contexts, thereby broadening the scope of his professional activity.

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€130
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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (5)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
5.0 (1055)
Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80

Frequently Asked Questions

Is a prescription required for MELATONITE 3 mg FILM-COATED TABLETS?
MELATONITE 3 mg FILM-COATED TABLETS does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in MELATONITE 3 mg FILM-COATED TABLETS?
The active ingredient in MELATONITE 3 mg FILM-COATED TABLETS is melatonin. This information helps identify medicines with the same composition but different brand names.
Who manufactures MELATONITE 3 mg FILM-COATED TABLETS?
MELATONITE 3 mg FILM-COATED TABLETS is manufactured by Pharma Nord Aps. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MELATONITE 3 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether MELATONITE 3 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to MELATONITE 3 mg FILM-COATED TABLETS?
Other medicines with the same active substance (melatonin) include CIRCADIN 2 mg PROLONGED-RELEASE TABLETS (30 tablets), CIRCADIN 2 mg PROLONGED-RELEASE TABLETS, MELATONIN ARROTEX 2 mg PROLONGED-RELEASE TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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