Melatonin Bluefish 2 mg prolonged-release tablets – patient leaflet, side effects, dosage

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

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

Melatonin Bluefish is used on its own for the short-term treatment of primary insomnia (persistent difficulty in getting to sleep or staying asleep, or poor quality of sleep) in patients aged 55 years and older. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.

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

Talk to your doctor or pharmacist before taking Melatonin Bluefish:

• If you have liver problems. No studies on the use

  of melatonin in people with liver diseases have been performed, you should speak to your doctor before taking Melatonin Bluefish as its use is not recommended.

• If you have kidney problems, you should speak

  to your doctor before taking Melatonin Bluefish.

• If you have an intolerance to some sugars.

• If you have an autoimmune disease (where the

  body is ‘attacked’ by its own immune system).

  No studies on the use of melatonin in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking Melatonin Bluefish as its use is not recommended.

  • Melatonin can make you feel drowsy, you should

    be careful if the drowsiness affects you as it may impair your ability on tasks such as driving.

  • Smoking may make Melatonin Bluefish less

    effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.

Children and adolescents

Do not give this medicine to children between the ages of 0 to 18 years as it has not been tested and its effects are unknown. Another medicine containing melatonin may be more appropriate for administration to children between the ages of 2 to 18 - please ask your doctor or pharmacist for advice.

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 for the treatment of depression

  and obsessive-compulsive disorder)

• psoralens (used in the treatment of skin disorders

  e.g. psoriasis)

• cimetidine (used in the treatment of stomach

  problems such as ulcers)

• quinolones (used in the treatment of bacterial

  infections)

• rifampicin (used to treat tuberculosis)

• oestrogens (used in contraceptives or hormone

  replacement therapy, see “Pregnancy and breast-feeding”)

• carbamazepine (used in the treatment of epilepsy)

• adrenergic agonists/antagonists (such as certain

  types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines)

• opiate agonists/antagonists (such as medicines

  used in the treatment of drug addiction)

• prostaglandin inhibitors (such as nonsteroidal

  anti-inflammatory medicines)

• antidepressant medication, 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).

Melatonin Bluefish with food, drink and alcohol

Take Melatonin Bluefish after you have eaten. Do not drink alcohol before, during or after taking Melatonin Bluefish, because it reduces the effectiveness of the medicine.

Pregnancy and breast-feeding

Do not take Melatonin Bluefish if you are pregnant, think you may be pregnant, trying to become pregnant or breast-feeding. Ask your doctor for advice before using this medicine.

Pregnancy

Melatonin Bluefish is not recommended if you are pregnant or if you are planning to have a baby. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child.

Breast-feeding

Melatonin Bluefish is not recommended if you are breast-feeding. Melatonin is passed into human breast milk, and a risk to the breast-fed child cannot be excluded.

Driving and using machines

Melatonin Bluefish may cause drowsiness. If you are affected, you should not drive or operate machinery. If you suffer from continued drowsiness, then you should consult your doctor.

Melatonin Bluefish contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Melatonin Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one Melatonin Bluefish tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime. This dosage may be continued for up to thirteen weeks.

Oral use. Tablets should be swallowed whole to maintain its prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.

If you take more Melatonin Bluefish than you should

If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.

Taking more than the recommended daily dose may make you feel drowsy.

If you forget to take Melatonin Bluefish

If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.

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

If you stop taking Melatonin Bluefish

There are no known harmful effects if treatment is interrupted or ended early. The use of melatonin is not known to cause any withdrawal effects after treatment completion.

Package leaflet: Information for the user

Melatonin Bluefish 2 mg prolonged release tablets

melatonin

Front

If you have any further questions on 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 1000 people)

• loss of consciousness or fainting
• severe chest pain due to angina
• feeling your heartbeat
• depression
• visual impairment
• blurred vision
• disorientation
• vertigo (a feeling of dizziness or “spinning”)
• presence of red blood cells in the urine
• reduced number of white blood cells in the blood

• reduced blood platelets, which increases risk of

  bleeding or bruising

• psoriasis

If you experience any of the following other side effects, contact your doctor and/or seek medical advice:

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

• irritability, nervousness, restlessness, insomnia,

  abnormal dreams, nightmares, anxiety

• migraine, headache, lethargy (tiredness, lack of

  energy), restlessness associated with increased activity, dizziness, sleepiness

• high blood pressure

• upper abdominal pain, indigestion, mouth

  ulceration, dry mouth, nausea

• changes in the composition of your blood which

  could cause yellowing of the skin or eyes

• inflammation of the skin, night sweats, itching,

  rash, dry skin

• pain in extremities
• menopausal symptoms
• feeling of weakness

• excretion of glucose in the urine, excess proteins

  in the urine

• abnormal liver function and weight increase.

Rare: (may affect up to 1 in 1000 people)

• shingles

• high level of fatty molecules in the blood, low

  serum calcium levels in the blood, low sodium levels in the blood

• altered mood, aggression, agitation, crying,

  stress symptoms, early morning awakening, increased sex drive, depressed mood

• memory impairment, disturbance in attention,

  dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling

• watery eyes
• dizziness when standing or sitting

• hot flushes

  • acid reflux, stomach disorder, blistering in the

    mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining

  • eczema, skin rash, hand dermatitis, itchy rash,

    nail disorder

  • arthritis, muscle spasms, neck pain, night cramps

  • prolonged erection that might be painful,

    inflammation of the prostate gland

  • tiredness, pain, thirst
  • passing large volumes of urine, urinating during the night

  • increased liver enzymes, abnormal blood

    electrolytes and abnormal laboratory tests.

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

• hypersensitivity reaction

• swelling of mouth or tongue, swelling of the

  skin (angioedema)

• abnormal milk secretion.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Melatonin Bluefish

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Melatonin Bluefish contains

• The active substance is melatonin. Each

  prolonged-release tablet contains 2 mg melatonin.

• The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate (E 341), ammonio methacrylate copolymer type B, talc (E 553b), colloidal anhydrous silica (E 551) and magnesium stearate (E 407b).

What Melatonin Bluefish looks like and contents of the pack

round, biconvex shaped with a diameter of 8 mm. The tablets are uncoated and plain on both sides

The tablets are packed in PVC/PE/PVDC- Aluminium blister packs.

Pack size: 30 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Gävlegatan 22

113 30 Stockholm

Sweden

This leaflet was last revised in 03/2025