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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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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Daria Portnova

Psychiatry 31 years exp.

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations. In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life. Patients consult Dr Daria Portnova for the following concerns: 

  • existential crises and complex life situations;
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Dr Portnova combines psychiatric assessment with a psychotherapeutic approach. She works with evidence-based methods, including cognitive behavioural therapy (CBT) and third-wave approaches such as ACT, FACT, and CFT. Consultations are focused on clear clinical understanding, practical recommendations, and ongoing support over time.

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Anastasiia Hladkykh

Psychiatry 15 years exp.

Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

Key areas of expertise:

  • Addiction treatment: alcohol and drug dependence, gambling addiction, compulsive behaviours, codependent relationships.
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  • Mental health: depression, bipolar disorder, obsessive-compulsive disorder (OCD), anxiety disorders, phobias, PTSD, generalised anxiety, emotional trauma, and the psychological impact of loss or emigration.
  • Psychoeducation: explaining complex mental health concepts in simple language, helping patients and their families understand diagnoses and treatment steps.
Therapeutic approach:
  • Client-centred, straightforward, and empathetic – focused on practical outcomes and emotional stabilisation.
  • Prescribes medications when needed, but always aims to minimise unnecessary pharmaceutical use.
  • Certified in multiple evidence-based methods: CBT, NLP (Master Practitioner), Ericksonian hypnosis, symbol drama, art therapy, and systemic therapy.
  • Each consultation results in a clear, structured plan – patients leave knowing exactly what to do next.
Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
  • More than 18 publications in international peer-reviewed journals, translated into several languages.
  • Volunteer work with Ukrainian refugees and military personnel at the University Clinic of Regensburg.
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Maria Martelli

Anaesthesiology 12 years exp.

Dr Maria Martelli is a medical doctor specialising in anaesthesiology and pain medicine. She provides online consultations for adults, focusing on the assessment and management of acute, chronic, and complex pain conditions, as well as supportive care in serious illness. She graduated from the Medical University of Silesia in Katowice and completed her specialisation in Anaesthesiology and Intensive Care. Alongside hospital work, she has extensive experience in home and inpatient hospice care, supporting patients with severe pain and advanced disease. Since 2021, she has been a certified specialist and continues to work in anaesthesiology, intensive care, and pain treatment. Patients consult her for: 

  • Chronic pain lasting more than 3 months (musculoskeletal, neuropathic, mixed pain).
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  • Post-operative pain and recovery support.
  • Cancer-related pain and symptom relief.
  • Palliative care support and quality-of-life improvement.
  • Adjustment and optimisation of pain medication.
  • Second opinions for complex or treatment-resistant pain.

Dr Martelli takes a structured, evidence-based approach, carefully analysing symptoms, previous treatments, and overall health status. Her consultations focus on realistic pain control goals, safety of therapy, and improving daily functioning. She is especially attentive to patients living with long-term pain or serious illness, providing clear explanations, compassionate guidance, and medically sound recommendations adapted to each individual situation.

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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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