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 are: EU/1/18/1318/001, EU/1/18/1318/002, EU/1/18/1318/005, PLGB 52348/0003 , PLGB 52348/0004.
Slenyto prolonged-release tablets 1mg and 5mg
slenyto 1 mg
slenyto 5 mg
For children and adolescents aged 2-18
1. What Slenyto is and what it is used for
2. What you need to know before you or your child takes Slenyto
3. How to take Slenyto
4. Possible side effects
5. How to store Slenyto
6. Contents of the pack and other information
Slenyto is a medicine that contains the active ingredient, melatonin. Melatonin is a hormone produced naturally by the body.
Slenyto is for use in children and adolescents (2 to 18 years old) with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, a neurogenetic disease (inherited condition affecting the nerves and brain).
Slenyto shortens the time it takes to fall asleep and lengthens the duration of sleep.
It is for the treatment of insomnia (sleeplessness) when a healthy sleeping routine (such as a regular bedtime and soothing sleeping environment) has not worked well enough.
The medicine can help you or your child fall asleep and may help you or your child sleep for longer during the night.
Talk to your doctor or pharmacist before taking Slenyto if you or your child:
Do not give this medicine to children below the age of 2 years as it has not been tested and its effects are unknown.
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
In particular, taking Slenyto with the following medicines can increase the risk of side effects, or it can affect the way that Slenyto or the other medicine works:
Smoking can increase the breakdown of melatonin by the liver, which may make this medicine less effective.
Please tell your doctor if you or your child starts or stops smoking during treatment.
Do not drink alcohol before, during or after taking Slenyto, because alcohol weakens the effect of the medicine.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Tell your doctor or pharmacist before using Slenyto if you or your daughter:
Slenyto may cause drowsiness. After taking this medicine, you or your child should not drive a vehicle, ride a bicycle, or use machinery until completely recovered.
If you or your child suffers from continued drowsiness, you should consult your doctor.
Slenyto contains lactose monohydrate. If you or your child has been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Slenyto is available in two strengths: 1 mg and 5 mg. The recommended starting dose is 2 mg (two 1-mg tablets) once daily. If there is no improvement in your/your child’s symptoms, your doctor may increase the dose of Slenyto to find the most suitable dose for you/your child. The maximum daily dose that you/your child will receive is 10 mg (two 5-mg tablets).
Slenyto should be taken in the evening, 30 to 60 minutes before bedtime. The tablets should be taken after the evening meal, i.e. on a full stomach.
How to take Slenyto
Slenyto is for oral use.
The tablets should be swallowed whole and NOT broken, crushed or chewed.
Crushing and chewing damages the special properties of the tablet and means that they will not work properly.
The whole tablets can be put into food like yoghurt, orange juice or ice-cream to help with swallowing. If the tablets are mixed with these foods, they should be given immediately and not left or stored, as this may affect the way the tablets work. If the tablets are mixed with any other type of food, the tablets may not work properly.
Slenyto is for use in the treatment of insomnia. You or your child should be monitored by your doctor at regular intervals (recommended every 6 months) to check that Slenyto is still the right treatment for you/them.
If you/your child has accidentally taken too much medicine, contact the doctor or pharmacist as soon as possible.
Taking more than the recommended daily dose may make you/your child feel drowsy.
If you or your child forgets to take a tablet, it could be taken before going to sleep that night, but after this time, no other tablet should be taken before the next evening.
Do not take a double dose to make up for a forgotten dose.
You should talk to your doctor before you/your child stops taking Slenyto. It is important to continue taking this medicine to treat the condition.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 to 1 in 10 people).
If this change in behaviour occurs, you must tell your doctor. The doctor may want you/your child to stop taking this medicine.
If any of the following side effects get serious or are troublesome, contact your doctor or seek medical advice:
Common: may affect between 1 in 100 to 1 in 10 people
Uncommon: may affect between 1 in 1000 to 1 in 100 people
Frequency not known (reported from use in adults)
If you or your child gets 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 national reporting system.
For the United Kingdom:
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 carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°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 to protect the environment.
1 mg strength
5 mg strength
1 mg strength
Slenyto 1 mg prolonged-release tablets are pink, film coated, round, biconvex, 3 mm diameter tablets.
Available in blister packs of 30 / 60 tablets.
5 mg strength
Slenyto 5 mg prolonged-release tablets are yellow, film coated, round, biconvex, 3 mm diameter tablets.
Available in blister packs of 30 tablets.
Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 10/2021.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu