Active ingredient
- melatonin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41344/0053 .
Melatonin 3 mg film-coated tablets
Package leaflet: Information for the user
Melatonin 3 mg film-coated tablets
Melatonin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
The name of your medicine is Melatonin 3 mg film-coated tablets, it will be referred to as Melatonin tablets for ease hereafter.
What is in this leaflet
1. What Melatonin tablets are and what they are used for
2. What you need to know before you use Melatonin tablets
3. How to use Melatonin tablets
4. Possible side effects
5. How to store Melatonin tablets
6. Contents of the pack and other information
1. What Melatonin tablets are and what they are used for
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.
2. What you need to know before you use Melatonin tablets
Do not take Melatonin tablets
Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonin tablets
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.
Melatonin tablets with food drink and alcohol
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.
3. How to use Melatonin tablets
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.
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)
Rare side effects (may affect up to 1 in 1000 people)
Not known (frequency cannot be estimated from available data)
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)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Not known (frequency cannot be estimated from available data)
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.
5. How to store Melatonin 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 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.
6. Contents of the pack and other information
What Melatonin tablets contain
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
Manufacturer
This leaflet was last revised in March 2019.
Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA
Reporting of side effects: +44 (0) 1892 739403
+44 (0) 1892 739403
+44 (0) 1892 739403