Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Melatonin tablets contain the active substance melatonin. Melatonin tablets can be used for treatment of jet-lag in adults. Jet-lag can be recognized by sleep disturbances, daytime tiredness, fatigue, mild mental impairment, irritability and digestive system disturbances experienced after flying.
How Melatonin tablets work
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.
Do not take Melatonin tablets • 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 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.
Children and adolescents Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy are unknown.
Other medicines and Melatonin tablets 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.
Melatonin tablets with food drink and alcohol • 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.
Pregnancy, breast-feeding and fertility 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.
Driving and using machines 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.
Melatonin tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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 for adults and elderly is 1 tablet daily for a maximum of 5 days. When the effect of Melatonin tablets is inadequate, 2 tablets can be taken simultaneously.
The first dose should be taken on arrival at destination at your usual bed-time. Intake on the following days should also be at your usual bed-time. The tablets should not be taken before 20:00 hr or after 04:00 hr.
The tablets should be swallowed whole with water or other liquid (e.g. milk, fruit juice). Food should not be consumed 2 hours before or 2 hours after intake of Melatonin tablets.
Melatonin tablets may be taken for a maximum of 16 treatment periods per year.
If you take more Melatonin tablets than you should 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 Melatonin tablets 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 If you stop taking Melatonin tablets, it will not have any harmful effects or withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects 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 1000 people)
• Reduced number of white blood cells in the blood
• Reduced number 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
Non-serious side effects 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)
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. 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.
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 carton and label after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
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.
What Melatonin tablets contain • Each film-coated tablet contains 3 mg of the active substance melatonin.
• The other ingredients are: cellulose microcrystalline, maltodextrin, silica coloidal anhydrous, magnesium stearate. Coating:hypromellose, lactose monohydrate, titanium dioxide and macrogol 4000.
What Melatonin tablets look like and contents of the pack Melatonin tablets are off white, round biconvex film-coated tablets of approx. 8 mm diameter and approx. 3 mm thickness.
Melatonin tablets are packed in blisters of PVC/PVdC-Aluminium.
Each blister contains 10 tablets.
Pack size: 30 tablets.
Marketing Authorisation Holder Colonis Pharma Ltd.
25 Bedford Square
Bloomsbury
London
WC1B 3HH
United Kingdom
Manufacturer RAFARM SA
Thesi Pousi-Xatzi Agiou Louka
Paiania Attiki
19002
PO Box 37
Greece
This leaflet was last revised in August 2021.
Colonis Pharma Ltd
Address
25 Bedford Square, Bloomsbury, London, WC1B 3HH
Medical Information Direct Line
+44 (0) 1932 555 026
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[email protected]
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Melatonin 3 mg film-coated tablets comes as tablet containing 3mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Melatonin 3 mg film-coated tablets is melatonin.
Medicines with the same active substance, strength and form include: Adaflex 3 mg Tablets, CEYESTO 3 mg Tablets, Mellozzan 3 mg Tablet. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Melatonin 3 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Melatonin 3 mg film-coated tablets are indicated for short-term treatment of jet-lag in adults.
Posology
The standard dose is 3 mg (1 tablet) daily for a maximum of 5 days. The dose may be increased to 6 mg (2 tablets taken together) if the standard dose does not adequately alleviate symptoms. The dose that adequately alleviates symptoms should be taken for the shortest period.
The first dose should be taken on arrival at destination at the habitual bed-time.
Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on re-synchronisation following jet-lag, Melatonin 3 mg film-coated tablets should not be taken before 20:00 hr or after 04:00 hr at destination.
Food can enhance the increase in plasma melatonin concentration (see Section 5.2). Intake of melatonin with carbohydrate-rich meals may impair blood glucose control for several hours (see Section 4.4). It is recommended that food is not consumed 2 h before and 2 h after intake of Melatonin 3 mg film-coated tablets.
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 when taking Melatonin 3 mg film-coated tablets.
Melatonin 3 mg film-coated tablets may be taken for a maximum of 16 treatment periods per year.
Elderly
As the pharmacokinetics of melatonin (immediate release) is comparable in young adults and elderly persons in general, no specific dosage recommendations for elderly persons are provided (see Section 5.2).
Renal impairment
There is only limited experience regarding the use of Melatonin 3 mg film-coated tablets in patients with renal impairment. Caution should be exercised if melatonin is used by patients with renal impairment. Melatonin 3 mg film-coated tablets is not recommended for patients with severe renal impairment (see Section 5.2).
Hepatic impairment
There is no experience regarding the use of Melatonin 3 mg film-coated tablets in patients with hepatic impairment. Limited data indicate that plasma clearance of melatonin is significantly reduced in patients with liver cirrhosis. Melatonin 3 mg film-coated tablets is not recommended in patients with moderate or severe hepatic impairment (see Section 5.2).
Paediatric population
The safety and efficacy of Melatonin 3 mg film-coated tablets in children and adolescents aged 0 – 18 years have not been established. Melatonin 3 mg film-coated tablets should not be used in children and adolescents due to safety and efficacy concerns (see Sections 4.4 and 5.1).
Method of administration
For oral use. Tablets should be swallowed whole with fluid.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Melatonin may cause drowsiness. Melatonin 3 mg film-coated tablets should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety.
Melatonin may increase seizure frequency in patients experiencing seizures (e.g. epileptic patients). Patients suffering from seizures must be informed about this possibility before using Melatonin 3 mg film-coated tablets. Melatonin may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects.
Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin. There are no data regarding use of Melatonin 3 mg film-coated tablets in patients with autoimmune diseases. Melatonin 3 mg film-coated tablets is not recommended in patients with autoimmune diseases.
Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours. Melatonin 3 mg film-coated tablets should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after meal by persons with significantly impaired glucose tolerance or diabetes.
Only limited data are available on the safety and efficiency of melatonin in patients with renal impairment or hepatic impairment. Melatonin 3 mg film-coated tablets is not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.
Paediatric population
The safety and efficacy of Melatonin 3 mg film-coated tablets in children and adolescents aged 0 – 18 years have not been established. Melatonin 3 mg film-coated tablets should not be used in children and adolescents due to safety and efficacy concerns (see Section 5.1).
Melatonin 3 mg film-coated tablets contain lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Interaction studies have only been performed in adults.
Pharmacokinetic interactions
• Melatonin is metabolised mainly by the hepatic cytochrome P450 CYP1A enzymes, primarily CYP1A2. Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes are possible.
• Caution is indicated in patients treated with fluvoxamine, since this agent increases melatonin levels (17-fold higher AUC and 12-fold higher serum Cmax) by inhibiting its metabolism via CYP1A2 and CYP2C19. This combination should be avoided.
• Caution is indicated in patients taking 5- or 8-methoxypsoralen (5 or 8-MOP), since this agent increases melatonin levels by inhibiting its metabolism.
• Caution is indicated in patients taking cimetidine, since this agent increases plasma melatonin levels by inhibiting its metabolism by CYP2D.
• Caution should be exercised in patients receiving estrogen therapy (e.g. in the form of contraceptives or hormone replacement therapy), since estrogens increase melatonin level by inhibiting its metabolism, primarily via inhibition of CYP1A2.
• CYP1A2 inhibitors (such as quinolones) may increase systemic melatonin levels.
• CYP1A2 inducers (such as carbamazepine and rifampicin) may reduce plasma concentrations of melatonin.
• Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.
Pharmacodynamic interactions
• Melatonin may enhance the sedative effect of benzodiazepines (e.g. midazolam, temazepam) and non-benzodiazepine hypnotics (e.g. zaleplon, zolpidem, zopiclone). In a study of jet-lag therapy the combination of melatonin and zolpidem resulted in a higher incidence of morning sleepiness, nausea, and confusion, and reduced activity during the first hour after getting up, compared to zolpidem alone.
• Melatonin may affect the anticoagulation activity of warfarin.
Pregnancy
There are no or limited amount of data for the use of melatonin in pregnant women.
Exogenous melatonin readily crosses the human placenta.
Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3).
Melatonin 3 mg film-coated tablets is not recommended during pregnancy or in women of childbearing potential not using contraception.
Breast-feeding
There is insufficient data on the excretion of melatonin / metabolites in human milk. Endogenous melatonin is secreted in human milk.
Available pharmacodynamic / toxicological data in animals have shown excretion of melatonin / metabolites milk (see Section 5.3).
A risk to the suckling child cannot be excluded.
Melatonin 3 mg film-coated tablets should not be used during breast-feeding.
Fertility
High doses of melatonin and use for longer periods than indicated may compromise fertility in humans.
Animal studies are insufficient with respect to effects on fertility (see Section 5.3).
Melatonin 3 mg film-coated tablets is not recommended in women and men planning pregnancy.
Melatonin has a moderate influence on the ability to drive and use machines. Melatonin may cause drowsiness and may decrease alertness for several hours, therefore use of Melatonin 3 mg film-coated tablets is not recommended prior to driving and using machines.
Summary of the safety profile
Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently report adverse effects when melatonin is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are also the adverse effects reported most frequently when typical clinical doses of melatonin have been taken for periods of several days to several weeks by healthy persons and patients.
Tabulated list adverse reactions
The following adverse reactions to melatonin in general have been reported in clinical trials or spontaneous case reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Very Common (≥ 1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Not known: (cannot be established from the available data)
Blood and lymphatic system disorders
leucopenia, thrombocytopenia
Immune system disorders
hypersensitivity reaction
Metabolism and nutrition disorders
hypertriglyceridaemia
hyperglycaemia
Psychiatric disorders
irritability, nervousness, restlessness, abnormal dreams, anxiety
mood altered, aggressive behaviour, disorientation, libido increased
Nervous system disorders
headache, somnolence
dizziness
syncope (fainting), memory impairment, restless legs syndrome, paraesthesia
Eye disorders
visual acuity reduced, vision blurred, lacrimation increased
Cardiac disorders
palpitations
Vascular disorders
hypertension
hot flushes
Gastrointestinal disorders
abdominal pain, upper abdominal pain, dyspepsia, oral ulcers, dry mouth, nausea
vomiting, flatulence, salivary hypersecretion, halitosis, gastritis
Skin and subcutaneous tissue disorders
pruritus, rash, dry skin
nail disorder
tongue edema, edema of the oral mucosa
Musculoskeletal and connective tissue disorders
arthritis, muscle spasms
Renal and urinary disorders
glycosuria, proteinuria
polyuria, haematuria
Reproductive system and breast disorders
priapism, prostatitis
galactorrhoea
General disorders and administration site conditions
chest pain, malaise
thirst
Laboratory and other examinations
weight increased
blood electrolytes abnormal
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
Drowsiness, headache, dizziness, and nausea are the most commonly reported signs and symptoms of overdose with oral melatonin.
Ingestion of daily doses of up to 300 mg of melatonin did not cause clinically significant adverse reactions.
Flushes, abdominal cramps, diarrhoea, headache, and scotoma lucidum have been reported after ingestion of extremely high melatonin doses (3000 – 6600 mg) for several weeks.
General supportive measures should be employed. Gastric lavage and administration of activated charcoal can be considered.
Clearance of the active substance is expected within 12 hours of ingestion.
Ask anything about Melatonin 3 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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