Melatonin 2 mg prolonged-release tablets

• 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 signs of illness are the same as yours.
• 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.

1. What Melatonin Milpharm tablets are and what they are used for
2. What you need to know before you take Melatonin Milpharm tablets
3. How to take Melatonin Milpharm tablets
4. Possible side effects
5. How to store Melatonin Milpharm 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 Milpharm tablets.

• If you suffer from liver or kidney problems. No studies on the use of Melatonin Milpharm tablets in people with liver or kidney diseases have been performed, you should speak to your doctor before taking Melatonin Milpharm tablets as its use is not recommended.
• If you have been told by your doctor that you have an intolerance to some sugars.
• If you have been told you suffer from an autoimmune disease (where the body is ‘attacked’ by its own immune system). No studies on the use of Melatonin Milpharm tablets in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking Melatonin Milpharm tablets as its use is not recommended.
• Melatonin Milpharm tablets 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 Milpharm tablets less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.

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.

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 and rifampicin (used in the treatment of bacterial infections), oestrogens (used in contraceptives or hormone replacement therapy) and 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 medicinal products 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) and imipramine (for the treatment of depression).

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

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

Melatonin Milpharm tablets 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 Milpharm tablets 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 medicinal product.

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 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.

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

If you get any side effects, talk to your doctor or pharmacist or nurse. 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 Yelow 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 prolonged-release tablet contains 2 mg melatonin.
• The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer (Type-B), silica (colloidal anhydrous), talc and magnesium stearate.

Melatonin Milpharm tablets are white to off-white, uncoated, round shaped biconvex tablets, plain on both sides. Melatonin Milpharm tablets are available in blister packs (i.e. white opaque PVC/PVdC – Aluminum blister).

Pack sizes:

Blister pack: 30 tablets

or