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 52497/0005.
Adaflex Tablets (1, 2, 3, 4 and 5mg)
Adaflex 1 mg tablets
Adaflex 2 mg tablets
Adaflex 3 mg tablets
Adaflex 4 mg tablets
Adaflex 5 mg tablets
1. What Adaflex is and what it is used for
2. What you need to know before you take Adaflex
3. How to take Adaflex
4. Possible side effects
5. How to store Adaflex
6. Contents of the pack and other information
The active substance of Adaflex, melatonin, belongs to a group of natural hormones produced by the body. The hormone helps regulate the body’s day- and night rhythm.
Adaflex is used for:
Talk to your doctor, pharmacist or nurse before taking Adaflex if you have:
Adaflex can make you feel drowsy. You should be careful if the drowsiness affects you, as it may impair your ability to perform tasks such as driving.
Smoking may reduce the effects of Adaflex. If you smoke, start to smoke or quit smoking, your doctor may need to adjust your dose.
Food should not be consumed 2 hours before or 2 hours after intake of Adaflex tablets. Do not drink alcohol in connection with taking Adaflex, as it may reduce the effect of melatonin on sleep.
Adaflex should not be given to children below the age of 6 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Adaflex is taken at the same time as the following medicines, it can affect the way that Adaflex or the other medicine works:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should not use Adaflex.
Adaflex 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.
Adaflex tablets are not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed child cannot be excluded.
Adaflex 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.
Adaflex can make you feel drowsy. If this happens, you must not drive or operate machinery.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you have impaired kidney function or are elderly, your doctor may need to reduce your dose.
The recommended dose is 1 to 5 mg for a maximum of 5 days.
Take the dose at the time of bedtime at the destination, when travelling over at least 5 time zones, especially for trips in an easterly direction. The tablets should not be taken before 20:00 hr or after 04:00 hr.
Adaflex for treatment of jet lag may be taken for a maximum of 16 treatment periods per year.
The recommended starting dose is 1 to 2 mg 30-60 minutes before bedtime. If there is no improvement in your/your child’s symptoms, your doctor may increase the dose of Adaflex to find the most suitable dose for you/your child. The maximum daily dose that you/your child will receive is 5 mg.
Treatment should be followed up regularly by a doctor (at least every 6 months is recommended) to see if it is still appropriate. Treatment should be interrupted once a year to see if treatment is still needed.
The tablet can be crushed before intake and mixed with water.
Food should not be consumed 2 hours before or 2 hours after intake of Adaflex tablets.
If you or your child has accidentally taken too much medicine or if for example a child has ingested the medicine by mistake, contact a doctor, hospital or pharmacist as soon as possible.
Taking more than the recommended daily dose may make you feel drowsy.
If you forget to take a dose 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 forgotten dose.
There are no known harmful effects if treatment is interrupted or ended. The use of Adaflex is not known to cause any withdrawal effects after treatment completion.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Adaflex and contact a doctor immediately:
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
Frequency not known: cannot be established from the available data
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 label after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order 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.
Adaflex 1 mg is a white, round, biconvex tablet with ”1” marked on one side, tablet size 9.5 x 3.8 mm.
Adaflex 2 mg is a white, round, biconvex tablet with ”2” marked on one side, tablet size 9.5 x 3.8 mm.
Adaflex 3 mg is a white, round, biconvex tablet with ”3” marked on one side, tablet size 9.5 x 3.8 mm.
Adaflex 4 mg is a white, round, biconvex tablet with ”4” marked on one side, tablet size 9.5 x 3.8 mm.
Adaflex 5 mg is a white, round, biconvex tablet with ”5” marked on one side, tablet size 9.5 x 3.8 mm.
Adaflex is available in bottle packs of 30 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in August 2023