Patient leaflet - Melatonin 3 mg film-coated tablets
1. What Melatonin 3 mg tablets are and what it is used for
Melatonin 3 mg tablets contain the active substance melatonin. Melatonin is a hormone produced naturally in the body. This hormone helps regulate the body’s day- and night rhythm.
Melatonin 3 mg tablets can be used for:
Short-term treatment of jet-lag, in adults only. Jet-lag
refers to the symptoms caused by the time difference when travelling across several time zones.
How Melatonin 3 mg tablets work
Melatonin is a hormone produced by the body that synchronises 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.
You must talk to a doctor if you do not feel better or if you feel worse when taking this medicine.
2. What you need to know before you take Melatonin 3 mg tablets
Do not take Melatonin 3 mg 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 3 mg tablets
if you suffer from seizures. Melatonin may increase
seizure frequency, for example 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. Please ensure that this medicine is taken at least 2 hours before a meal or at least 3 hours after a meal if you suffer from diabetes.
if you suffer from moderately to significantly impaired
liver function or significantly impaired kidney function.
if you smoke. Smoking may reduce the effect of
Melatonin 3 mg tablets as components of tobacco smoke can increase the breakdown of melatonin by the liver.
if you suffer from hypertension and are being treated for
this. Melatonin 3 mg tablets may reverse the beneficial effects of blood pressure-lowering medicines.
This medicine 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.
Children and adolescents
Do not give this medicine to children and adolescents between 0 and 18 years as its safety and effectiveness in the short-term treatment of jet-lag are unknown.
Other medicines and Melatonin 3 mg 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.
Imipramine (used for the treatment of depression), as
both medicines taken together enhance feelings of drowsiness and can cause difficulty in performing tasks.
Thioridazine (used for the treatment of mental/mood
disorders), as both medicines taken together enhance feelings of drowsiness and difficulty in performing tasks.
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.
Oestrogens (used in contraceptives or hormone
replacement therapy), as oestrogens may increase the effect of melatonin.
Quinolones (used for the treatment of bacterial
infections), as quinolones may increase the effect of melatonin.
Rifampicin (used for 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.
Warfarin and other blood-thinning medicines, e.g.
dabigatran, rivaroxaban, apixaban, edoxaban, as melatonin may interfere with the effect of these medicines. It may be necessary to measure the time for the blood to clot, also known as an INR-test.
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 medicines, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion).
Nifedipine and other calcium channel blocker medicines
(used for the treatment of high blood pressure), as both medicines taken together may increase blood pressure.
- Caffeine (stimulant), as melatonin interacts with caffeine.
Melatonin 3 mg tablets with food 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, impaired concentration) it is recommended that alcohol is not consumed while taking this medicine.
- Consuming alcohol while taking this medicine may lead to increased drowsiness.
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 3 mg 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 a woman of childbearing potential, you have to use contraception.
Breast-feeding
Melatonin 3 mg tablets are not recommended if you are breast-feeding. Melatonin passes into human milk, and a risk to the breast-fed infant or child cannot be excluded.
Fertility
Melatonin 3 mg 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 3 mg 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 3 mg tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take 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 h or after 04:00 h.
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 until at least 3 hours after a meal.
You must talk to a doctor if you do not feel better or if you feel worse when taking this medicine.
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 h.
Do not take a double dose to make up for a missed dose.
I-7679-11 I-7679-11 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.
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)
- Chest pain.
Rare side effects
(may affect up to 1 in 1,000 people)
- Reduced number of white blood cells in the blood.
Reduced number of blood platelets, which increases the
risk of bleeding or bruising.
- Disorientation.
- Fainting.
- Visual impairment, including blurred vision.
- Chest pain due to angina pectoris.
- 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
Other side effects
If you experience any of the following other side effects, contact your doctor or pharmacist:
Uncommon side effects
(may affect up to 1 in 100 people)
Irritability, nervousness, restlessness, sleeplessness,
abnormal dreams, nightmares, anxiety.
- Migraine, headache, lethargy, drowsiness.
- Restlessness associated with increased activity.
- Dizziness.
- High blood pressure.
Abdominal pain, upper abdominal pain, indigestion,
mouth ulceration, dry mouth, nausea.
Changes in the composition of your blood that can
cause yellowing of the skin and eyes.
Inflammation of the skin, night sweats, itching, rash, dry
skin.
- Pain in the extremities.
Excretion of glucose in the urine, excess protein in the
urine.
- Menopausal symptoms in women.
- Feeling unwell.
- Abnormal results in liver function tests.
- Weight increase.
Rare side effects
(may affect up to 1 in 1,000 people)
- Herpes zoster.
High levels of certain fat molecules (triglycerides) in the
blood.
- Low calcium or sodium levels in the blood.
Altered mood, aggression, crying, stress symptoms,
early morning awakening, increased sex drive.
- Depression.
Memory impairment, disturbance in attention, dreamy
state, restless legs syndrome, ‘pins and needles’ sensation.
- Watery eyes.
Vertigo (a feeling of dizziness or “spinning”), dizziness
when standing or sitting, vertigo positional.
- Hot flushes.
Acid reflux, gastrointestinal disorder, blistering in the
mouth, tongue ulceration, stomach upset.
Vomiting, abnormal bowel sounds, wind, excess saliva,
bad breath, abdominal discomfort, inflammation of the stomach lining.
Eczema, erythema, dermatitis of the hands, psoriasis,
nail disorder.
- Arthritis, muscle spasms, neck pain, night cramps.
- Passing large volumes of urine, need to urinate at night.
Prolonged erection that might be painful, inflammation
of the prostate gland.
- Tiredness, pain, thirst.
Increased liver enzymes, 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 or your relatives 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.
5. How to store Melatonin 3 mg tablets
- 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 outer carton and blister after EXP. The expiry date refers to the last day of that month.
- This medicine does not require any special temperature storage conditions.
- This medicine should be stored in the original packaging in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Melatonin 3 mg tablets contain
The active substance is melatonin.
Each tablet contains 3 mg melatonin.
The other ingredients are:
Tablet core: magnesium stearate, colloid silica anhydrous, maltodextrin, microcrystalline cellulose, croscarmellose sodium.
Film-coating: hypromellose.
What Melatonin 3 mg tablets look like and contents of the pack
Round, biconvex, clear-coated, white to off-white tablet. Size 7.5 mm.
Blister pack containing 10, 20 or 30 film-coated tablets, in carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharma Nord ApS
Tinglykke 4-6
6500 Vojens
Denmark
Local representative
Pharma Nord (UK) Ltd.,
Telford Court, Morpeth,
Northumberland,
NE61 2DB, UK
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Filmtabletten
Denmark Melatonin Pharma Nord
Estonia Melatoniin Pharma Nord 3 mg
õhukese polümeerikattega tabletid
Finland Melatonin Pharma Nord 3 mg, kalvopäällysteinen tabletti / filmdragerade tablett
Germany Melatonin Pharma Nord 3 mg
Filmtabletten
Hungary Melatonin Pharma Nord 3 mg filmtabletta
Ireland Melatonin Pharma Nord 3 mg film-coated tablets
Latvia Melatonin Pharma Nord 3 mg apvalkotās tabletes
Lithuania Melatoninas Pharma Nord 3 mg plėvele dengtos tabletės
Luxembourg Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Filmtabletten
Netherlands Melatonine Pharma Nord 3 mg filmomhulde tabletten
Norway Melatonin Pharma Nord
Poland Melatonina Pharma Nord 3 mg tabletki powlekane
Portugal Melatonina Pharma Nord 3 mg, comprimidos revestidos por película
Slovenia Melatonin Pharma Nord 3 mg filmsko obložene tablete
Spain Melatonite 3 mg
comprimidos recubiertos con película
Sweden Melatonin Pharma Nord 3 mg filmdragerade tabletter
United
Kingdom (NI)
Melatonin 3 mg, film-coated tablets