Slenyto: detailed information

Package leaflet: Information for the user

Slenyto 1 mg prolonged-release tablets, 5 mg prolonged-release tablets

melatonin
Please read this leaflet carefully before you or your child take this medicine,
because it contains important information.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours or your child's, because it could be harmful.
If you or your child experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Slenyto is and what it is used for
What you need to know before you or your child take Slenyto
How to take Slenyto
Possible side effects
How to store Slenyto
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 substance melatonin. Melatonin is a hormone
naturally produced by the body.
What it is used for
Slenyto is used for the treatment of insomnia (inability to sleep) in:

Children and adolescents (aged between 2 and 18 years) with autism spectrum disorder (ASD) and/or neurogenetic diseases (inherited disorders affecting nerves and brain) associated with abnormal melatonin levels and/or nocturnal awakenings, in cases where healthy sleep routines (such as going to bed at a regular time and having a relaxing sleep environment) have not been sufficient.
Children and adolescents (aged between 6 and 17 years) with attention deficit hyperactivity disorder (ADHD), in cases where healthy sleep routines (such as going to bed at a regular time and having a relaxing sleep environment) have not been sufficient.

Slenyto shortens the time needed to fall asleep and prolongs the duration of sleep. The medicine may help you or your child to fall asleep faster and sleep 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 are allergic to melatonin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Slenyto if you or your child:

have liver or kidney problems. Consult your doctor before taking/giving Slenyto, as its use is not recommended in such cases.
have an autoimmune disease (a condition in which the body is attacked by its own immune system). Consult your doctor before taking/giving Slenyto, as its use is not recommended in such cases.

Slenyto may cause drowsiness and daytime fatigue. Caregivers should monitor the child
for any signs of daytime fatigue and, if these symptoms occur, contact the
doctor for advice.
In particular, children and adolescents with ADHD may experience an increase in daytime symptoms,
such as inattention, hyperactivity, or behavioral disorders.
Children
The safety and efficacy of Slenyto in children under 6 years of age with ADHD have not been
established.
Do not give this medicine to children under 2 years of age, as it has not yet been tested in this age group and its effects are unknown.
Other medicines and Slenyto
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
In particular, taking Slenyto together with the following medicines may increase the risk of side effects, or may affect how Slenyto or the other medicines work:

fluvoxamine (used to treat depression and obsessive-compulsive disorder)
methoxypsoralens (used in the treatment of skin disorders, for example psoriasis)
cimetidine (used to treat stomach problems such as ulcers)
quinolones (e.g. ciprofloxacin and norfloxacin) and rifampicin (used to treat bacterial infections)
estrogens (used in contraceptives or hormone replacement therapy)
carbamazepine (used to treat epilepsy)
non-steroidal anti-inflammatory drugs such as aspirin and ibuprofen (used to treat pain and inflammation). These medicines should be avoided, especially in the evening.
beta-blockers (used to control blood pressure). These medicines should be taken in the morning.
benzodiazepine and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone (used to induce sleep)
thioridazine (used to treat schizophrenia)
imipramine (used to treat depression)

Smoking
Smoking may increase the breakdown of melatonin by the liver, which could reduce
the effectiveness of the medicine. Consult your doctor if you or your child starts or stops smoking
during treatment.
Slenyto and alcohol
Do not drink alcohol before, during or after taking Slenyto, as alcohol weakens the effect of the
medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
Talk to your doctor or pharmacist before taking Slenyto if you or your daughter:

are or might be pregnant. As a precautionary measure, it is preferable to avoid using melatonin during pregnancy.
are breastfeeding or planning to breastfeed. Melatonin may pass into breast milk; therefore, your doctor will decide whether you or your daughter can breastfeed while taking melatonin.

Driving and using machines
Slenyto may cause drowsiness. After taking this medicine, you or your child should not
drive a vehicle, ride a bicycle, or operate machinery until fully recovered.
If you or your child experience persistent drowsiness, you should consult your doctor.
Slenyto contains lactose
Slenyto contains monohydrate lactose. If your doctor has diagnosed you or your child with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Slenyto

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Slenyto is available in two strengths: 1 mg and 5 mg.
Insomnia in children and adolescents (aged between 2 and 18 years) with neurodevelopmental
disorders (NDD) and/or neurogenetic diseases (inherited conditions affecting nerves and the brain)
associated with abnormal melatonin levels and/or nocturnal awakenings.
The recommended starting dose is 2 mg (two 1 mg tablets) once daily. If no improvement in symptoms
is observed in you/your child, your doctor may increase the dose of Slenyto to identify the most suitable
dose for you/your child. The maximum daily dose you/your child will receive is 10 mg (two 5 mg tablets).
You/your child will be monitored by your doctor at regular intervals (every 6 months is recommended) to
ensure that Slenyto remains the appropriate treatment for you/your child.
Insomnia in children and adolescents (aged between 6 and 17 years) with ADHD
The recommended starting dose is 1–2 mg (one to two 1 mg tablets) once daily. If there is no
improvement in your/your child’s symptoms, the dose may be individually adjusted to 5 mg daily,
regardless of age. If your doctor considers it necessary, the maximum daily dose may be increased to
10 mg (two 5 mg tablets) daily.
The lowest possible dose for the shortest possible duration will be prescribed.
You/your child should be reviewed by your doctor at regular intervals (it is recommended every
6 months) to confirm that Slenyto remains appropriate for you/your child.
Treatment should be interrupted once a year to assess whether it is still needed.

When to take Slenyto
Slenyto should be taken in the evening, 30 to 60 minutes before bedtime. The tablets should be taken
after dinner, that is, with a full stomach.

How to take Slenyto
Slenyto is intended for oral use. The tablets must NOT be divided, crushed, or chewed, but must be
swallowed whole. Chewing or crushing damages the special properties of the tablet, reducing its
effectiveness.
Whole tablets may be mixed with food such as yogurt, orange juice, or ice cream to facilitate
swallowing. If the tablets are mixed with such foods, they must be administered immediately and must
not be stored or saved for later use, as this may compromise their effectiveness. Mixing the tablets with
other types of food may reduce their effectiveness.

If you or your child takes more Slenyto than you should
If you/your child has taken an excessive dose of this medicine, contact your doctor or pharmacist as
soon as possible.
Taking more than the recommended daily dose may cause drowsiness.

If you or your child forgets to take Slenyto
If you or your child forgets to take a tablet, it may be taken before bedtime on the same night; after that
time, no tablet should be taken until the following evening.
Do not take a double dose to make up for a forgotten dose.

If you or your child stops taking Slenyto
Please consult your doctor before stopping treatment with Slenyto for yourself or your child. It is
important to continue taking this medicine for the treatment of the disorder.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Unpredictable changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 and 1 in 10 people). If this change in behaviour occurs, consult your doctor. The doctor may instruct you/your child to stop taking the medicine.

If any of the following side effects worsen or become troublesome, consult your doctor.

Common: may affect between 1 in 100 and 1 in 10 people

Mood swings
Aggression
Irritability
Drowsiness
Headache
Sudden sleep
Swelling and inflammation of the sinuses associated with pain and blocked nose (sinusitis)
Fatigue
Hangover-like feeling

Uncommon: may affect between 1 in 1,000 and 1 in 100 people

Depression
Nightmares
Restlessness
Stomach ache

Frequency not known (reported with another pharmaceutical form and dosage)

Seizures (epilepsy)
Visual disturbances
Shortness of breath (dyspnoea)
Nosebleeds (epistaxis)
Constipation
Reduced appetite
Facial swelling
Skin lesions
Feeling of abnormality
Abnormal behaviour
Low white blood cell count (leucopenia)

Reporting of side effects
If you or your child experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Slenyto

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Slenyto contains
1 mg strength

The active substance is melatonin. Each tablet contains 1 mg of melatonin.
The other components are ammonium methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc, magnesium stearate, sodium carboxymethylcellulose (E466), maltodextrin, glucose monohydrate, lecithin (E322), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

5 mg strength

The active substance is melatonin. Each tablet contains 5 mg of melatonin.
The other components are ammonium methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), magnesium stearate, sodium carboxymethylcellulose (E466), maltodextrin, glucose monohydrate, lecithin (E322), titanium dioxide (E171) and iron oxide yellow (E172).

Description of the appearance of Slenyto and contents of the pack
1 mg strength
Slenyto 1 mg prolonged-release tablets are pink, film-coated, round, biconvex tablets with a diameter of 3 mm.
Available in blister packs of 30/60 tablets.
5 mg strength
Slenyto 5 mg prolonged-release tablets are yellow, film-coated, round, biconvex tablets with a diameter of 3 mm.
Available in blister packs of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux
75002 Paris
France
e-mail: [email protected]

Manufacturer
Iberfar Indústria Farmacêutica, S.A.
Estrada Consiglieri Pedroso 123,
Queluz De Baixo
Barcarena
2734-501
Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tél/Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

България Luxembourg/Luxemburg
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Teл.: +33 185149776 (FR) Tél/Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

Česká republika Magyarország
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel.: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

Danmark Malta
Takeda Pharma A/S RAD Neurim Pharmaceuticals EEC SARL
e-mail: [email protected] Tel: +33 185149776 (FR)
e-mail: [email protected]

Deutschland Nederland
INFECTOPHARM Arzneimittel und Consilium RAD Neurim Pharmaceuticals EEC SARL
GmbH Tel: +33 185149776 (FR)
Tel: +49 6252 957000 e-mail: [email protected]
e-mail: [email protected]

Eesti Norge
RAD Neurim Pharmaceuticals EEC SARL Takeda AS
Tel: +33 185149776 (FR) e-mail: [email protected]
e-mail: [email protected]

Ελλάδα Österreich
INNOVIS PHARMA A.E.B.E. RAD Neurim Pharmaceuticals EEC SARL
Τηλ: +30 216 200 5600 Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

España Polska
EXELTIS HEALTHCARE, S.L. RAD Neurim Pharmaceuticals EEC SARL
Tel: +34 91 7711500 Tel.: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

France Portugal
BIOCODEX Laboratórios Azevedos – Indústria Farmacêutica,
Tél: +33 (0)1 41 24 30 00 S.A.
e-mail: [email protected] Tel: +351 214 725 900
e-mail: [email protected]

Hrvatska România
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

Ireland Slovenija
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

Ísland Slovenská republika
Williams & Halls ehf. RAD Neurim Pharmaceuticals EEC SARL
Sími: +354 527 0600 Tel: +33 185149776 (FR)
Netfang: [email protected] e-mail: [email protected]

Italia Suomi/Finland
Fidia Farmaceutici S.p.A. RAD Neurim Pharmaceuticals EEC SARL
Tel: +39 049 8232222 Puh/Tel: +33 185149776 (FR)
e-mail: [email protected] e-mail: [email protected]

Κύπρος Sverige
RAD Neurim Pharmaceuticals EEC SARL Takeda Pharma AB
Τηλ: +33 185149776 (FR) e-mail: [email protected]
e-mail: [email protected]

Latvija
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu