MELATONIN BLUEFISH 2 mg PROLONGED-RELEASE TABLETS

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.

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.

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:

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