Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Melatonin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Melatonin 3 mg tablets contains the active substance melatonin. Melatonin 3 mg tablets can be used for treatment of short-term 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 3 mg tablets works 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 a jet-lag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Melatonin 3 mg tablets can help restore the normal dayand-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.
e Melatonin 3 mg tablets
Do not take Melatonin 3 mg tablets
Melatonin 3 mg tablets
Always take this medicine exactly as described in this leaflet or 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 3 mg tablets is inadequate, 2 tablets can be taken simultaneously the following evening. The dose that reduces symptoms sufficiently should be taken for the shortest period necessary. 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. Tablet(s) should not be taken before 20:00 hr or after 04:00 hr. Tablets should be swallowed whole with water or other liquid (e.g. milk, fruit juice). Food should not be consumed at least 2 hours before or at least 2 hours after intake of Melatonin 3 mg tablets. If you have impaired glucose tolerance or diabetes Melatonin 3 mg tablets should ideally not be taken at least 3 hours after a meal. Melatonin 3 mg tablets may be taken for a maximum of 16 treatment periods per year. If you take more Melatonin 3 mg tablets than you should If you have taken more Melatonin 3 mg 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 3 mg tablets If you forget to take a tablet(s) 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 3 mg tablets If you stop taking this medicine, it will not have any harmful effects or withdrawal symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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4. Possible side effects
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)
you can help provide more information on the safety of this medicine.
Melatonin 3 mg tablets
I-XXXX-AB
What Melatonin 3 mg tablets contains
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Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Filmtabletten Melatonin Pharma Nord
Melatoniin Pharma Nord 3 mg õhukese polümeerikattega tabletid Melatonin Pharma Nord 3 mg, kalvopäällysteinen tabletti / filmdragerade tablett Melatonin Pharma Nord 3 mg Filmtabletten Melatonin Pharma Nord 3 mg filmtabletta Melatonin Pharma Nord 3 mg film‐coated tablets Melatonin Pharma Nord 3 mg apvalkotās tabletes
Melatoninas Pharma Nord 3 mg plėvele dengtos tabletės
Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Filmtabletten Melatonine Pharma Nord 3 mg filmomhulde tabletten Melatonin Pharma Nord
Melatonina Pharma Nord 3 mg tabletki powlekane
Melatonina Pharma Nord 3 mg, comprimidos revestidos por película Melatonin Pharma Nord 3 mg filmsko obložene tablete
Melatonite 3 mg comprimidos recubiertos con película Melatonin Pharma Nord 3 mg filmdragerade tabletter
Melatonin 3 mg film-coated tablets
This leaflet was last revised in 02/2025.
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.
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 to cause an adverse reaction, on re-synchronisation following jet-lag, Melatonin 3 mg 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 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 tablets.
Melatonin 3 mg 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 dose recommendations for elderly persons are provided (see section 5.2).
Renal impairment
There is only limited experience regarding the use of Melatonin 3 mg tablets in patients with renal impairment. Caution should be exercised if melatonin is used by patients with renal impairment. Melatonin 3 mg tablets are 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 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 tablets are not recommended in patients with hepatic impairment (see section 5.2).
Impaired glucose tolerance
As intake of melatonin with carbohydrate-rich meals may impair blood glucose control for several hours (see section 4.4), it is recommended that Melatonin 3 mg tablets are taken at least 3 h after intake of a meal by persons with significantly impaired glucose tolerance or diabetes.
Paediatric population
The safety and efficacy of Melatonin for the short-term treatment of jet-lag in children and adolescents aged 0 to 18 years have not been established. Melatonin 3 mg tablets should not be used for the treatment of jet-lag in children and adolescents aged 0 to 18 years because of safety and efficacy concerns (see sections 4.4 and 5.1).
Method of administration
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 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. Melatonin 3 mg tablets 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. Melatonin 3 mg tablets are 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 tablets should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after a 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 tablets are not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.
Cardiovascular conditions
There are limited data that melatonin may cause adverse effects on blood pressure and heart rate in populations with cardiovascular conditions and concurrent antihypertensive medications. It is unclear whether these adverse effects are attributable to melatonin itself or to melatonin-drug interactions. Melatonin is not recommended for use in patients with cardiovascular conditions and concurrent antihypertensive medication (see section 4.5).
Paediatric population
The safety and efficacy of melatonin for the short-term treatment of jet-lag in children and adolescents aged 0 to 18 years have not been established. Melatonin 3 mg tablets are therefore not recommended for the treatment of jet-lag in children and adolescents (see section 5.1).
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.
Pharmacokinetic interactions
• Melatonin is metabolised mainly by the hepatic cytochrome P450 CYP1A enzymes, primarily CYP1A2 (see section 5.2). 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 oestrogen therapy (e.g. in the form of contraceptives or hormone replacement therapy), since oestrogens 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 reverse the beneficial effects of antihypertensive medicinal products and increase blood pressure and heart-rate in hypertensive patients treated with such, with especial concern for calcium channel blockers (such as nifedipin).
• Melatonin may affect the anticoagulation activity of warfarin.
• Alcohol is a sedative with the ability to alter physical and mental functions. There is a potential for patients to have enhanced drowsiness when alcohol is co-administered with melatonin (see section 4.2).
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
There are no or limited amount of data from 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 tablets are not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
There is insufficient information on the excretion of melatonin / metabolites in human milk. Endogenous melatonin is excreted in human milk.
Available pharmacodynamic / toxicological data in animals have shown excretion of melatonin / metabolites in milk (for details see 5.3).
A risk to the newborns/infants cannot be excluded.
Melatonin 3 mg 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 tablets are 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 tablets are not recommended prior to driving or using machines.
Summary of the safety profile
Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently reported adverse reactions when melatonin is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are also the adverse reactions 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 summary of 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 estimated 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,
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 ulceration,
dry mouth,
nausea
vomiting,
flatulence,
salivary hypersecretion,
halitosis,
gastritis
Skin and subcutaneous tissue disorders
pruritus,
rash,
dry skin
nail disorder
tongue oedema,
oral mucosa swollen
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
Investigations
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 (3,000 to 6,600 mg) for several weeks.
General supportive measures should be employed.
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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