CEYESTO 3 mg 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 Ceyesto is and what it is used for
2. What you need to know before you take Ceyesto
3. How to take Ceyesto
4. Possible side effects
5. How to store Ceyesto
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 Ceyesto, if you suffer from:

• Epilepsy. Ceyesto may increase seizure frequency in patients with epilepsy.
• Renal impairment. The use of Ceyesto if you have kidney disease is not recommended.
• Hepatic impairment. The use of Ceyesto if you have liver disease is not recommended.
• Autoimmune disease (where the body is ‘attacked’ by its own immune system). The use of melatonin in this case is not recommended.
• A cardiovascular condition for which you use antihypertensive medication. The use of melatonin in this case is not recommended.

The timing of the melatonin dosing is important. Ceyesto should be used as instructed.

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

Ceyesto should not be given to children and adolescents under 18 years old for the treatment of jet lag.

Ceyesto should not be given to children below the age of 6 years with ADHD.

The safety profile of melatonin especially in long-term use is not fully established. Long-term melatonin use may negatively affect blood glucose control, pubertal development and sexual maturation.

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),
• Quinolones and rifampicin (used in the treatment of bacterial infections), oestrogens (used in contraceptives or hormone replacement therapy), carbamazepine (used in the treatment of epilepsy) and 5- or 8-methoxypsoralen (5 and 8-MOP) (used in the treatment of skin diseases such as psoriasis).
• Adrenergic agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines), opioid agonists /antagonists (such medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medicines), antidepressant medication, tryptophan and alcohol.
• Cimetidine (used for the treatment of stomach problems such as ulcers), calcium channel blockers (medicines used to treat high blood pressure and sudden chest pain [angina pectoris], such as nifedipine).
• 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).
• Warfarin and other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (used to prevent blood clotting) – INR may be necessary to verify more specifically.

Food may alter the effectiveness of Ceyesto. It is recommended that food is not consumed 2 hours before or 2 hours after the scheduled time of melatonin intake. Do not drink alcohol before, during or after taking Ceyesto, because it reduces the effectiveness of Ceyesto and it can potentially worsen certain symptoms of jet-lag (e.g. headache, morning fatigue, impaired concentration).

The use of Ceyesto during pregnancy is not recommended. Ceyesto should not be used if you are breast-feeding.

Ceyesto has moderate influence on the ability to drive and use machines. Melatonin may cause drowsiness. Alertness may be affected for several hours after taking melatonin. Do not drive or operate machinery after you have taken melatonin.

The recommended dose is one 3 mg tablet daily for a maximum of 4 days. The first dose should be taken on arrival at your destination at your usual bedtime (local time). The dose on the following days should also be at your usual bedtime. Other dosages from other manufacturers are available to achieve higher than 3 mg dose if required.

Timing of melatonin is important, because if taken at the wrong time, melatonin may cause sleepiness and delay adaptation to local time. Therefore, the tablets should not be taken before 20:00 hr or after 04:00 hr.

Consult a doctor if the symptoms do not improve within 6 days or if they get worse.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age as the safety and efficacy of melatonin in the treatment of jet lag has not been established.

Your doctor will decide the starting dose and if needed will increase the dose of melatonin to find the most suitable dose for you/your child. The tablet is taken 30-60 minutes before bedtime. The maximum daily dose that you/your child will receive is 3 mg. Ceyesto is suitable only when the lowest effective dose has been established by your doctor to be 3 mg.

Your doctor should evaluate the treatment effect at regular intervals and consider stopping treatment if no clinically relevant treatment effect is seen.

Children below 6 years of age

Ceyesto tablets are not recommended for children below 6 years with ADHD. The safety and efficacy of melatonin in children less than 6 years has not been established.

If you have taken too much of your medicine or if a child has accidentally taken this medicine, always contact a doctor or hospital to assess the risks and to get additional instructions. Taking more than the recommended daily dose may make you feel drowsy.

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 Ceyesto is not known to cause any withdrawal effects after treatment completion.

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.

The active substance is melatonin.

Each 3 mg tablet contains 3 mg of melatonin.

The other ingredients are:

Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Silica colloidal anhydrous and Starch pregelatinised.

White, round, convex tablet with logo 7, diameter 7 mm.

10, 30 and 50 tablets in blister packs (PVC/Al) or in tablet container (container HD-PE plastic and closure LD-PE plastic)

Not all pack sizes may be marketed.