Melatonin 3mg film-coated tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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.

The name of your medicine is Melatonin 3 mg film-coated tablets, it will be referred to as Melatonin tablets for ease hereafter.

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

Melatonin is a hormone produced by the body that synchronizes the body’s biological day-and-night rhythm. The biological rhythm can be disturbed by travelling across time zones. This is known as jet-lag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Melatonin tablets can help restore the normal day-and-night rhythm and reduce the symptoms.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

• 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 tablets

• if you have epilepsy. Melatonin may increase seizure frequency 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
• if you suffer from significantly impaired liver function or kidney function
• if you smoke. Smoking may reduce the effect of Melatonin tablets as components of tobacco smoke can increase the breakdown of melatonin by the liver.

Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy 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
• Estrogens (used in contraceptives or hormone replacement preparations), as estrogens 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
• 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 drugs, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion)
• Warfarin (anticoagulants), as melatonin may influence the effect of the anticoagulant warfarin

• 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, concentration) it is recommended that alcohol is not consumed while taking this medicine.

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 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 woman of childbearing potential you have to use contraception.

Breast-feeding

Melatonin tablets are not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the sucking child cannot be excluded.

Fertility

Melatonin 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 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.

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

If you have taken more Melatonin 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 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 Melatonin tablets, it will not have any harmful effects or withdrawal symptoms.

• 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
• Excretion of glucose in the urine, excess protein in the urine
• Feeling unwell
• Weight increase

Rare side effects (may affect up to 1 in 1000 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 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.

Each film-coated tablet contains 3 mg of the active substance melatonin.

The other ingredients are:

• core tablet includes microcrystalline cellulose, maltodextrin, croscarmellose sodium, colloidal anhydrous silica and Magnesium stearate
• film-coating includes hypromellose, macrogol and titanium dioxide

Melatonin tablets are white coloured, round biconvex film-coated tablets with a diameter of 7.00mm debossed with ‘31’ on one side and ‘Y’ on other side.

Melatonin tablets are packed in blisters of Alu-Alu pack or PVC/PVdC-Aluminium blister packs. Pack size: 30 tablets.