Melatonin 3 mg film-coated tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

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

• if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Melatonin 3 mg tablets

• if you suffer from seizures. Melatonin may increase seizure frequency, for example 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 the level of glucose in your blood. Please ensure that you do not take this medicine 2 hours before a meal and wait at least 3 hours after a meal if you suffer from diabetes.
• if you suffer from moderately to significantly impaired liver function or significantly impaired kidney function.
• if you smoke. Smoking may reduce the effect of Melatonin 3 mg tablets as components of tobacco smoke can increase the breakdown of melatonin by the liver.
• if you suffer from hypertension and are being treated for this. Melatonin 3 mg tablets may reverse the beneficial effects of blood pressure-lowering medicines.
• This medicine 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.

Do not give this medicine to children and adolescents between 0 and 18 years as its safety and effectiveness in the short-term treatment of jet-lag are unknown.

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

• Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin.
• Psoralens (used for the treatment of skin disorders e.g. psoriasis), as psoralens may increase the effect of melatonin.
• Cimetidine (used for the treatment of stomach problems such as ulcers), as cimetidine may increase the effect of melatonin.
• Oestrogens (used in contraceptives or hormone replacement therapy), as oestrogens may increase the effect of melatonin.
• Quinolones (used in the treatment of bacterial infections), as quinolones may increase the effect of melatonin.
• Rifampicin (used in the treatment of bacterial infections), as rifampicin may decrease the effect of melatonin.
• Carbamazepine (used in the treatment of epilepsy), as carbamazepine may decrease the effect of melatonin.
• Warfarin (used as a blood thinner), 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 enhance the sedative effect of such medicines, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion).

• This medicine should not be taken with food (see section 3).
• As alcohol can impair sleep and potentially worsen certain symptoms of jet-lag (e.g. headache, morning fatigue, impaired concentration) it is recommended that alcohol is not consumed while taking this medicine.
• Consuming alcohol while taking this medicine may lead to increased drowsiness.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Melatonin 3 mg tablets are not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are a woman of childbearing potential you have to use contraception.

Breast-feeding

Melatonin 3 mg tablets are not recommended if you are breast-feeding. Melatonin passes into human milk, and a risk to the breast-fed infant or child cannot be excluded.

Fertility

Melatonin 3 mg tablets are not recommended in women and men planning to have a baby as there is insufficient information on the effects of melatonin on female and male fertility.

Melatonin 3 mg tablets may cause drowsiness and may decrease alertness for several hours after intake. Therefore, this medicine should not be taken prior to driving or using machines.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

If you have taken more Melatonin 3 mg tablets than recommended and you do not feel well, please contact your doctor, hospital or pharmacy.

The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.

If you forget to take a tablet(s) at bedtime and wake during the night you may take the forgotten dose but at no later than 04:00 hr.

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

If you stop taking this medicine, it will not have any harmful effects or withdrawal symptoms.

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)

• Reduced number of white blood cells in the blood.
• Reduced number of blood platelets, which increases the risk of bleeding or bruising.
• Disorientation.
• Fainting.
• Visual impairment, including blurred vision.
• Feeling your heartbeat (‘pounding chest’).
• Blood (red blood cells) in the urine.

Not known

(frequency cannot be estimated from available data)

• Severe allergic reaction resulting in swelling of the tongue or lining of the mouth

If you experience any of the following other 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.
• Excretion of glucose in the urine, excess protein in the urine.
• Feeling unwell.
• Weight increase.

Rare side effects

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

• High levels of certain fat molecules (triglycerides) in the blood.
• Altered mood, aggression, increased sex drive.
• Memory impairment, restless legs syndrome, ‘pins and needles’ sensation.
• Watery eyes.
• Hot flushes.
• Vomiting, wind, excess saliva, bad breath, inflammation of the stomach lining.
• Nail disorder.
• Arthritis, muscle spasms.
• Passing large volumes of urine.
• Prolonged erection that might be painful, inflammation of the prostate gland.
• Thirst.
• Abnormal levels of electrolytes in the blood.

Not known

(frequency cannot be estimated from available data)

• Hypersensitivity reactions.
• High blood glucose level.
• Flow of milk from the breasts (also in men).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You or your relatives can also report side effects directly via the 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.

• The active substance is melatonin.
  Each tablet contains 3 mg melatonin.
• The other ingredients are:
  Tablet core: magnesium stearate, colloid silica anhydrous, maltodextrin, microcrystalline cellulose, croscarmellose sodium.
  Film-coating: hypromellose.

Round, biconvex, clear-coated, white to off-white tablet. Size 7.5 mm.

Blister pack containing 10 or 30 film-coated tablets, in carton.

Not all pack sizes may be marketed.

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