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: PL41344/0058 .
Melatonin 2mg Hard Capsules
Package leaflet: Information for the user
Melatonin 2 mg, 3 mg, 5 mg Hard Capsules
Melatonin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Melatonin Hard Capsules are and what they are used for
2. What you need to know before you use Melatonin Hard Capsules
3. How to use Melatonin Hard Capsules
4. Possible side effects
5. How to store Melatonin Hard Capsules
6. Contents of the pack and other information
The name of your medicine is Melatonin 2mg, 3mg or 5mg hard capsules. It will be referred to as Melatonin hard capsules for ease of use hereafter.
1. What Melatonin Hard Capsules are and what they are used for
Melatonin Hard Capsules contain the active substance melatonin. Melatonin Hard Capsules 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 Hard Capsules 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 Hard Capsules 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 Hard Capsules
Do not take Melatonin Hard Capsules
Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonin Hard Capsules:
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 Hard Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Melatonin Hard Capsules 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 Hard Capsules 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 Hard Capsules 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 Hard Capsules 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 Hard Capsules 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 2 mg Hard Capsules and Melatonin 5 mg Hard Capsules contain sodium.
These medicines contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to use Melatonin Hard Capsules
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, including the elderly, is 3 mg daily for a maximum of 5 days. The dose may be increased to 5 mg or 6 mg (2 capsules of 3 mg taken simultaneously) when the effect of Melatonin Hard Capsules is inadequate. A lower dose of 2 mg may be sufficient for some individuals.
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 capsules should not be taken before 20:00 hr or after 04:00 hr.
The capsules 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 Hard Capsules.
Melatonin Hard Capsules may be taken for a maximum of 16 treatment periods per year.
If you take more Melatonin Hard Capsules than you should
If you have taken more Melatonin Hard Capsules 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 Hard Capsules
If you forget to take a capsule 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 Hard Capsules
If you stop taking Melatonin Hard Capsules, 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 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 Hard Capsules
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 25ºC.
Keep in the outer carton 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.
6. Contents of the pack and other information
What Melatonin Hard Capsules contain
Melatonin 2 mg Hard Capsules
Melatonin 3 mg Hard Capsules
Melatonin 5 mg Hard Capsules
What Melatonin Hard Capsules look like and contents of the pack
Melatonin 2 mg Hard Capsules: are size 3, opaque hard gelatin capsules, with a white body and light blue cap.
Melatonin 3 mg Hard Capsules: are size3, opaque hard gelatin capsules, with a white body and white cap.
Melatonin 5 mg Hard Capsules: are size 1, opaque hard gelatin capsules, with a light blue body and light blue cap.
They are packed in PVC/PVDC/aluminium blisters. Each blister contains 7 or 10 capsules.
Pack sizes: 10, 14, 28, 30 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in May 2020.
For information in large print, Braille or on CD, telephone 01892 739403.
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