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MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS

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About the medicine

How to use MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE 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

Patient Information Leaflet

Melatonin Bluefish 2 mg prolonged-release tablets EFG

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Melatonin Bluefish is and what it is used for

The active substance of Melatonin Bluefish is melatonin and belongs to a group of natural hormones produced by the body.

Melatonin Bluefish is used on its own for the short-term treatment of primary insomnia (persistent difficulty falling asleep or staying asleep, or poor quality sleep) in patients aged 55 and over. "Primary" means that the insomnia has no identifiable cause, whether medical, mental, or environmental.

Doctor consultation

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2. What you need to know before you take Melatonin Bluefish

Do not take Melatonin Bluefish

  • 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 taking Melatonin Bluefish.

  • If you have liver problems. No studies have been conducted on the use of melatonin in people with liver disease; you should talk to your doctor before taking melatonin, as its use is not recommended.
  • If you have kidney problems, you should talk to your doctor before taking melatonin.
  • If you are intolerant to certain sugars.
  • If you have an autoimmune disease (when the body is "attacked" by its own immune system). No studies have been conducted on the use of melatonin in people with autoimmune diseases; therefore, you should talk to your doctor before taking melatonin, as its use is not recommended.
  • Melatonin can cause drowsiness; you should be careful if you experience drowsiness, as it may affect your ability to perform tasks such as driving.
  • Smoking can reduce the effectiveness of melatonin, as the components of tobacco smoke can increase the breakdown of melatonin in the liver.

Children and adolescents

This medicine should not be given to children or adolescents from 0 to 18 years, as it has not been evaluated in this population and its effects are not known. For administration to children from 2 to 18 years, another melatonin medicine may be more suitable; consult your doctor or pharmacist.

Other medicines and Melatonin Bluefish

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

  • fluvoxamine (used to treat depression and obsessive-compulsive disorder),
  • psoralens (used to treat skin diseases, such as psoriasis),
  • cimetidine (used to treat stomach problems, such as ulcers),
  • quinolones (used to treat bacterial infections),
  • rifampicin (used to treat tuberculosis),
  • estrogens (used as contraceptives or in hormone replacement therapy, see "Pregnancy and breastfeeding"),
  • carbamazepine (used to treat epilepsy),
  • adrenergic agonists and antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, or medications to lower blood pressure),
  • opioid agonists and antagonists (such as some medications used in the treatment of addictions),
  • prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs),
  • antidepressant medications, tryptophan, and alcohol,
  • benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, such as zaleplon, zolpidem, and zopiclone),
  • thioridazine (for the treatment of schizophrenia),
  • imipramine (for the treatment of depression).

Taking Melatonin Bluefish with food, drinks, and alcohol

Take melatonin after you have eaten some food. Do not drink alcohol before, after, or during melatonin administration, as it reduces the effectiveness of the medicine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant. Consult your doctor or pharmacist before using this medicine.

Pregnancy

Melatonin is not recommended if you are pregnant or plan to have a baby. Melatonin crosses the placenta, and there is not enough information about the risk it may pose to the fetus.

Breastfeeding

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

Driving and using machines

Melatonin can cause drowsiness. In that case, do not drive or operate machinery. Consult your doctor if you experience continuous drowsiness.

Melatonin Bluefish contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Melatonin Bluefish

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

The recommended dose is one tablet (2 mg) of melatonin per day, taken orally after eating some food, 1 or 2 hours before bedtime. This dose may be extended for a maximum of thirteen weeks.

Oral use. You should swallow the tablet whole to maintain its prolonged-release properties. Do not crush or chew to facilitate swallowing.

If you take more Melatonin Bluefish than you should

If you accidentally take more medicine than you should, go to your doctor or pharmacist as soon as possible.

Taking a higher dose than recommended per day may cause drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Melatonin Bluefish

If you forget to take the tablet, take it as soon as you remember, before bedtime, or wait until the next dose and then continue as before.

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

If you stop taking Melatonin Bluefish

Stopping or prematurely ending treatment does not cause any known harmful effects. The use of melatonin does not cause withdrawal effects after treatment ends.

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

Medicine questions

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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.

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

Uncommon: (may affect up to 1 in 100 people)

  • Chest pain

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

  • Loss of consciousness or fainting
  • Severe chest pain due to angina pectoris
  • Perception of heartbeats
  • Depression
  • Visual impairment
  • Blurred vision
  • Disorientation
  • Dizziness (feeling of dizziness or that "everything is spinning")
  • Presence of red blood cells in the urine
  • Decreased number of white blood cells in the blood
  • Decreased number of platelets in the blood, which increases the risk of bleeding or bruising
  • Psoriasis

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

Uncommon: (may affect up to 1 in 100 people)

  • Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety
  • Migraine, headache, lethargy (fatigue, lack of energy), restlessness associated with increased activity, dizziness, exhaustion
  • High blood pressure, abdominal pain, indigestion, mouth ulcers, dry mouth, nausea
  • Alteration of blood composition that can cause a yellowish tint to the skin or eyes, skin inflammation, night sweats, itching, skin rash, dry skin
  • Pain in the limbs
  • Menopausal symptoms
  • Feeling of weakness
  • Glucose in the urine, excess protein in the urine
  • Abnormal liver function and weight gain.

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

  • Shingles
  • Increased concentration of fat molecules in the blood, reduced calcium concentration in the blood, reduced sodium concentration in the blood
  • Mood alteration, aggression, agitation, crying, stress symptoms, waking up early, increased libido (increased sexual desire), depressive mood
  • Memory impairment, attention disturbance, daydreaming, restless legs syndrome, poor quality sleep, sensation of pins and needles
  • Increased tearing
  • Dizziness when standing up or sitting down
  • Hot flashes
  • Acid reflux, digestive disorders, mouth ulcers, tongue ulcers, stomach discomfort, vomiting, abnormal intestinal sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach disorders, stomach mucosa inflammation
  • Eczema, skin redness, hand dermatitis, skin redness and itching, nail disorders
  • Arthritis, muscle spasms, neck pain, nocturnal cramps
  • Prolonged erection that can be painful, prostate inflammation
  • Fatigue, pain, thirst, increased urine output, need to urinate at night
  • Increased liver enzymes, electrolyte abnormalities in the blood, and laboratory test abnormalities.

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

  • Hypersensitivity reaction
  • Swelling of the mouth or tongue, swelling of the skin (angioedema)
  • Abnormal milk secretion.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonin Bluefish

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 stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Melatonin Bluefish

  • The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
  • The other ingredients (excipients) are lactose monohydrate, calcium hydrogen phosphate dihydrate (E 341), ammonio methacrylate copolymer type B, talc (E 553b), anhydrous colloidal silica (E 551), and magnesium stearate (E 407b).

Appearance and packaging

The prolonged-release tablets are white to off-white, round, biconvex, and 8 mm in diameter. The tablets are not coated and are smooth on both sides.

The tablets are packaged in PVC/PE/PVDC-Aluminum blisters.

Pack size: 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

or

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06 Industrial Estate

San Gwann

SGN 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany

Melatonin Bluefish 2 mg Retardtabletten

Austria

Melatonin Bluefish 2 mg Retardtabletten

Denmark

Melatonin Bluefish

Spain

Melatonina Bluefish 2 mg comprimidos de liberación prolongada EFG

France

Melatonine Bluefish LP 2 mg, comprimé à libération prolongée

Iceland

Melatonin Bluefish 2 mg forðatöflur

Norway

Melatonin Bluefish 2 mg depottabletter

Portugal

Melatonina Bluefish 2 mg comprimidos de libertação prolongada

United Kingdom (NI)

Melatonin Bluefish 2 mg prolonged-release tablets

Sweden

Melatonin Bluefish

Date of last revision of this leaflet:December 2024

Other sources of information

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

Online doctors for MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS

Discuss questions about MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (148)
Doctor

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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Doctor

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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0.0 (0)
Doctor

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).
  • Acute pain requiring medical assessment and treatment planning.
  • 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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Doctor

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.
  • Support for families of addicted individuals, behavioural correction within the family system, guidance for maintaining remission.
  • 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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Frequently Asked Questions

Is a prescription required for MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS?
MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS requires 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 MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS?
The active ingredient in MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS is melatonin. This information helps identify medicines with the same composition but different brand names.
Who manufactures MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS?
MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS is manufactured by Bluefish Pharmaceuticals Ab (Publ). Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE 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 MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE 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 MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE 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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