Slenyto

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

melatonin

Available from:

RAD Neurim Pharmaceuticals EEC SARL

ATC code:

N05CH01

INN (International Name):

melatonin

Therapeutic group:

Psycholeptics

Therapeutic area:

Sleep Initiation and Maintenance Disorders; Autistic Disorder

Therapeutic indications:

Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2018-09-20

Patient Information leaflet

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
SLENYTO 1 MG PROLONGED-RELEASE TABLETS
SLENYTO 5 MG PROLONGED-RELEASE TABLETS
melatonin
For children and adolescents aged 2-18
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you or your child only. Do not
pass it on to others. It
may harm them, even if their signs of illness are the same as yours or
your child’s.
-
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. See section 4.
WHAT IS IN THIS LEAFLET
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
1.
WHAT SLENYTO IS AND WHAT IT IS USED FOR
WHAT SLENYTO IS
Slenyto is a medicine that contains the active ingredient, melatonin.
Melatonin is a hormone produced
naturally by the body.
WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES SLENYTO
DO NOT TAKE SLENYTO IF YOU OR YOUR CHILD
-
is allergic to melatonin or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Slenyto 1 mg prolonged-release tablets
Slenyto 5 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Slenyto 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1 mg melatonin.
Excipient with known effect
Each prolonged-release tablet contains lactose monohydrate equivalent
to 8.32 mg lactose.
Slenyto 5 mg prolonged-release tablets
Each prolonged-release tablet contains 5 mg melatonin.
Excipient with known effect
Each prolonged-release tablet contains lactose monohydrate equivalent
to 8.86 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged- release tablet.
Slenyto 1 mg prolonged-release tablets
Pink, film coated, round, biconvex, 3 mm diameter tablets with no
imprint.
Slenyto 5 mg prolonged-release tablets
Yellow, film coated, round, biconvex, 3 mm diameter tablets with no
imprint.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Slenyto is indicated for the treatment of insomnia in children and
adolescents aged 2-18 with Autism
Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep
hygiene measures have
been insufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 2 mg of Slenyto. If an inadequate
response has been observed, the
dose should be increased to 5 mg, with a maximal dose of 10 mg.
Slenyto should be taken once daily, 0.5-1 hour before bedtime and with
or after food.
3
Data are available for up to 2 years’ treatment. The patient should
be monitored at regular intervals (at
least every 6 months) to check that Slenyto is still the most
appropriate treatment. After at least
3 months of treatment, the physician should evaluate the treatment
effect and consider stopping
treatment if no clinically relevant treatment effect is seen. If a
lower treatment effect is seen after
titration to a higher dose, the prescriber should first consider a
down-titration to a lower dose before
deciding on a