Leaflet: information for the user

Slenyto 1 mg prolonged-release tablets

Slenyto 5 mg prolonged-release tablets

melatonin

Read this leaflet carefully before your child starts taking this medicine, as it contains important information.

• Keep this leaflet, as 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, and should not be given to others even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Slenyto

Slenyto is a medication that contains the active ingredient melatonin. Melatonin is a hormone produced naturally by the body.

What is it used for

Slenyto is used to treatinsomnia(inability to fall asleep) in:

• children and adolescents(ages 2 to 18) withautism spectrum disorder (ASD)and/orneurogenetic disorders(hereditary conditions affecting the nerves and brain) associated with abnormal melatonin levels and/or nighttime awakenings, if other healthy sleep routines (e.g., a regular bedtime and a relaxing sleep environment) have not been sufficient.
• children and adolescents(ages 6 to 17)withattention deficit hyperactivity disorder (ADHD), if other healthy sleep routines (e.g., a regular bedtime and a relaxing sleep environment) have not been sufficient.

Slenyto shortens the time it takes to fall asleep and prolongs the duration of sleep.

The medication may help you or your child fall asleep and may help you or your child sleep for a longer period during the night.

Do not take Slenyto if you or your child:

• are allergic to melatonin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Slenyto if you or your child:

• has liver or kidney problems. Consult your doctor before taking/administering Slenyto, as its use is not recommended in such cases.
• has an autoimmune disease (in which the body's defense system attacks parts of the body). Consult your doctor before taking/administering Slenyto, as its use is not recommended in such cases.

Slenyto may cause drowsiness and daytime fatigue. Caregivers should monitor the child for signs of daytime fatigue and seek advice from your doctor if symptoms appear.

Particularly, children and adolescents with ADHD may experience an increase in daytime symptoms such as inattention, hyperactivity, or behavioral alterations.

Children

The safety and efficacy of Slenyto in children under 6 years of age with ADHD have not been confirmed.

Do not administer this medication to children under 2 years of age, as it has not been tested and its effects are unknown.

Other medications and Slenyto

Inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take any other medication.

Particularly, taking Slenyto with the following medications may increase the risk of adverse effects or may affect how Slenyto or the other medication works:

• fluvoxamine(used for the treatment of depression and obsessive-compulsive disorder)
• methoxypsoralens(used in the treatment of skin disorders such as psoriasis)
• cimetidine(used in the treatment of stomach problems such as ulcers)
• quinolones(such as ciprofloxacin and norfloxacin) andrifampicin(used in the treatment of bacterial infections)
• estrogens(used in contraceptives or hormone replacement therapy)
• carbamazepine(used in the treatment of epilepsy)
• nonsteroidal anti-inflammatory drugssuch as aspirin and ibuprofen (used to treat pain and inflammation). These medications should be avoided, especially at night.
• beta-blockers(used to control blood pressure). These medications should be taken in the morning.
• benzodiazepinesandnon-benzodiazepine hypnoticssuch as zaleplon, zolpidem, and zopiclone (used to induce sleep)
• thioridazine(used in the treatment of schizophrenia)
• imipramine(used in the treatment of depression)

Tobacco

Tobacco may increase the breakdown of melatonin by the liver, making this medication less effective. Inform your doctor if you or your child starts or stops smoking during treatment.

Taking Slenyto with alcohol

Do not drink alcohol before, during, or after taking Slenyto, as alcohol weakens the effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Inform your doctor or pharmacist before starting to use Slenyto if you or your daughter:

• is pregnant or may be pregnant. As a precaution, it is recommended to avoid the use of melatonin during pregnancy.
• • is breastfeeding or plans to breastfeed. It is possible that melatonin may pass into human breast milk, so your doctor will decide whether you or your daughter should breastfeed while taking melatonin.

Driving and operating machinery

Slenyto may cause drowsiness. After taking this medication, you or your child should not drive a vehicle, ride a bicycle, or operate machinery until you have fully recovered.

If you or your child experience continuous drowsiness, you should consult your doctor.

Slenyto contains lactose

Slenyto contains lactose monohydrate. If your doctor has told you or your child that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Slenyto is available in two concentrations: 1 mg and 5 mg.

Insomnia in children and adolescents (2 to 18 years old) with ADHD and/or neurogenetic diseases (hereditary conditions affecting the nerves and brain) associated with abnormal melatonin levels and/or nighttime awakenings.

The recommended initial dose is 2 mg (two 1 mg tablets) once a day. If your symptoms or your child's symptoms do not improve, your doctor may increase the dose of Slenyto to determine the most suitable dose for you or your child. The maximum daily dose you or your child will receive is 10 mg (two 5 mg tablets).

Your doctor should monitor you or your child regularly (recommended every 6 months) to check that Slenyto is still the appropriate treatment for you or your child.

Insomnia in children and adolescents (6 to 17 years old) with ADHD

The recommended initial dose is 1-2 mg (one or two 1 mg tablets) once a day. If there is no improvement in your symptoms or your child's symptoms, the dose may be adjusted individually to 5 mg daily, regardless of age. If the doctor considers it necessary, the maximum daily dose may be increased to 10 mg (two 5 mg tablets) per day.

The lowest possible dose will be administered, for the shortest possible time.

Your doctor should monitor you or your child regularly (recommended every 6 months) to check that Slenyto is still the appropriate treatment for you or your child.

Treatment should be interrupted once a year to check if it is still necessary.

When to take Slenyto

Slenyto should be taken at night, between 30 and 60 minutes before bedtime. The tablets should be taken after dinner, i.e., with a full stomach.

How to take Slenyto

Slenyto is administered orally.The tablets must be swallowed whole, without breaking, crushing, or chewing. If the tablets are crushed or chewed, their special properties will be altered and they will not work correctly.

Thewhole tabletscan be introduced into foods such as yogurt, orange juice, or ice cream to help swallow them. If the tablets are mixed with these foods, they must be taken immediately and not left or stored, as this may affect how the tablets work. If the tablets are mixed with any other type of food, they may not work correctly.

If you or your child take more Slenyto than you should

If you or your child have taken an accidental overdose of the medication, contact your doctor or pharmacist as soon as possible.

Taking a dose higher than the recommended daily dose may cause you or your child to feel drowsy.

If you or your child forget to take Slenyto

If you or your child forget to take a tablet, you can take it before bedtime that night, but do not take any other tablet until the next night.

Do not take a double dose to compensate for the missed doses.

If you or your child interrupt treatment with Slenyto

You should consult your doctor before you or your child interrupt treatment with Slenyto. It is essential to continue taking this medication to treat the disorder.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Unpredictable changes in behavior, such as aggression (which may affect up to 1 in 10 people), may occur.If this change in behavior occurs, you should inform your doctor. The doctor may want you or your child to stop taking this medication.

If any of the following adverse effects become severe or bothersome, contact your doctor or seek medical attention:

Frequent: may affect up to 1 in 10 people

• Mood changes
• Aggression
• Irritability
• Drowsiness
• Headache
• Sudden sleep
• Swelling and inflammation of the breasts associated with pain and nasal obstruction (sinusitis)
• Fatigue
• Sensation of hangover

Unknown frequency(reported from adult use)

• Epilepsy
• Visual impairment
• Lack of breath/difficulty breathing (dyspnea)
• Nasal bleeding (epistaxis)
• Constipation
• Loss of appetite
• Swelling of the face
• Skin lesion
• Abnormal sensation
• Abnormal behavior
• Low white blood cell count (neutropenia)

Reporting Adverse Effects

If you or your child experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Slenyto

Dose of 1 mg

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

Dose of 5 mg

• The active ingredient is melatonin. Each tablet contains 5 mg of melatonin.
• The other components are copolymer of amonio methacrylate type A, calcium dihydrogen phosphate, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, sodium carmellose (E466), maltodextrin, glucose monohydrate, lecithin (E322), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the package

Dose of 1 mg

Slenyto 1 mg prolonged-release tablets are film-coated, pink, round, biconvex, and 3 mm in diameter.

Available in blisters of 30/60 tablets.

Dose of 5 mg

Slenyto 5 mg prolonged-release tablets are film-coated, yellow, round, biconvex, and 3 mm in diameter.

Available in blisters of 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux

75002 Paris

France

Email: regulatory@neurim.com

Responsible for manufacturing

Iberfar - Indústria Farmacêutica, S.A.

Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo

Barcarena

2734-501

Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update date of this leaflet: {month/YYYY}

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.