Patient leaflet - CEYESTO 3 MG TABLETS
1. what ceyesto is and what it is used for
The active substance of Ceyesto, melatonin, belongs to a natural group of hormones produced by the body.
Ceyesto is used for short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when travelling through several time zones – travelling east or west.
2. what you need to know before you take ceyesto
Do not take Ceyesto:
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– 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 Ceyesto, if you suffer from:
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- epilepsy. Ceyesto may increase seizure frequency in patients with epilepsy.
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- renal impairment. The use of Ceyesto if you have kidney disease is not recommended.
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- hepatic impairment. The use of Ceyesto if you have liver disease is not recommended.
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- autoimmune disease (where the body is ‘attacked’ by its own immune system). The use of melatonin in this case is not recommended.
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- 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.
Children and adolescents
Do not give this medicine to children under 18 years old as it has not been tested and its effects are unknown.
Other medicines and Ceyesto
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).
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- 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.
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- 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).
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- Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone).
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- Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
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- Warfarin and other anticoagulants , e.g. dabigatran, rivaroxaban, apixaban, edoxaban (used to prevent blood clotting) – INR may be necessary to verify more specifically.
Ceyesto with food, drink and alcohol
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).
Pregnancy and breastfeeding
The use of Ceyesto during pregnancy is not recommended. Ceyesto should not be used if you are breast feeding.
Driving and using machines
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.
3. how to take ceyesto
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 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. Tablets should be swallowed with a glass of water. It is recommended that food is not consumed within 2 hours before or 2 hours after the scheduled time of melatonin intake.
Consult a doctor if the symptoms do not improve within 6 days or if they get worse.
If you take more Ceyesto than you should
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.
If you forget to take Ceyesto
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ceyesto
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 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.
Potential adverse reactions in short-term use for jet lag are headache, nausea, loss of appetite, dizziness, daytime sleepiness, and disorientation.
Frequency not known :
(cannot be established from the available data) Swelling of mouth or tongue, and 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.
When used for other disorders melatonin has been reported to cause a spectrum of adverse effects.
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
- Disorientation
- Vertigo (a feeling of dizziness or “spinning”)
- Presence of blood in the urine
- Reduced number of white blood cells in the blood
- Reduced blood platelets, which increases risk of bleeding or bruising
- Psoriasis
You can also report side effects directly via Yellow Card Scheme, Website: 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 Ceyesto
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 label or carton (EXP). The expiry date refers to the last day of that month.
Store in the original package in order to protect from light. 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.
| Frequency not known: |
6. Contents of the pack and other information
(cannot be estimated from the available data)
- Hypersensitivity reaction
What Ceyesto contains
- Swelling of the skin
The active substance is melatonin.
Each 3 mg tablet contains 3 mg of melatonin.
If you experience any of the following non-serious side effects contact your doctor and/ or seek medical advice:
The other ingredients are:
Calcium hydrogen phosphate dehydrate,
Uncommon: (may affect up to 1 in 100 people)
Microcrystalline cellulose, Magnesium stearate,
- Irritability
Silica colloidal anhydrous,
- Nervousness
Starch pregelatinised.
- Restlessness
What Ceyesto looks like and contents of the pack
White, round, convex tablet with logo 7, diameter- Insomnia
composition of your
- Abnormal dreams
blood which could cause
7 mm.
- Nightmares
yellowing of the skin or eyes
- Anxiety
10, 30 and 50 tablets in blister packs (PVC/Al) or in
- Migraine
tablet container (container HD-PE plastic and closure
- Headache
LD-PE plastic)
- Lethargy (tiredness, lack
Not all pack sizes may be marketed.
of energy)
- Dry skin
Marketing Authorisation Holder and Manufacturer
with increased activity
- Excretion of glucose in
the urine
Marketing Authorisation Holder:
- Tiredness
Alturix Limited
- High blood pressure
287 Upper Fourth Street
- Abdominal pain
Milton Keynes
- Indigestion
MK9 1EH
- Mouth ulceration
United Kingdom
Rare: (may affect up to 1 in 1000 people)
- Shingles Excess saliva production
Manufacturer:
Vitabalans Oy Varastokatu 7–9
- High level of fatty
13500 Hameenlinna
molecules in the blood
- Abdominal discomfort
Finland
- Altered mood
This medicinal product is authorised in the
- Agitation
stomach lining
Member States of the EEA under the following
- Crying
names:
- Stress symptoms
Ceyesta: Finland
- Early morning awakening
Ceyesto: United Kingdom
- Increased sex drive
This leaflet was last revised in 12.2020
- Depressed mood
of urine
- Watery eyes
or sitting
might be painful
- Hot flushes
prostate gland
- Stomach disorder
- Tiredness
- Blistering in mouth
- Pain
- Tongue ulceration
- Thirst
- Stomach upset
- Increased liver enzymes
- Vomiting
- Abnormal blood electrolytes
- Abnormal bowel sounds
- Wind
- Abnormal laboratory tests