SLENYTO 5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Slenyto 1 mg prolonged-release tablets

Slenyto 5 mg prolonged-release tablets

melatonin

Read all of this leaflet carefully before 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 your child, do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
• If your child experiences any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Slenyto and what is it used for
2. What you need to know before you or your child starts taking Slenyto
3. How to take Slenyto
4. Possible side effects
5. Storing Slenyto
6. Contents of the pack and other information

1. What is Slenyto and what is it used for

What is Slenyto

Slenyto is a medicine that contains the active substance melatonin. Melatonin is a hormone that is naturally produced by the body.

What is Slenyto used for

Slenyto is used to treat insomnia (difficulty falling asleep) in:

• children and adolescents(from 2 to 18 years of age) with autism spectrum disorder (ASD)and/or neurogenetic disorders(hereditary disorders that affect the nerves and brain) associated with abnormal melatonin levels and/or nighttime awakenings, if other healthy sleep routines (e.g., regular bedtime and relaxing sleep environment) have not worked well enough.
• children and adolescents(from 6 to 17 years of age) with attention deficit hyperactivity disorder (ADHD), if other healthy sleep routines (e.g., regular bedtime and relaxing sleep environment) have not worked well enough.

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

The medicine can help your child fall asleep and can help your child sleep longer during the night.

2. What you need to know before you or your child starts taking Slenyto

Do not take Slenyto if your child:

• is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Slenyto if 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 (where the body's immune system attacks parts of the body). Consult your doctor before taking/administering Slenyto, as its use is not recommended in such cases.

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

In particular, children and adolescents with ADHD may experience an increase in daytime symptoms such as lack of attention, hyperactivity, or behavioral changes.

Children

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

Do not give this medicine to children under 2 years of age, as its effects are unknown.

Other medicines and Slenyto

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

In particular, taking Slenyto with the following medicines may increase the risk of side effects or may affect how Slenyto or the other medicine works:

• fluvoxamine(used to treat depression and obsessive-compulsive disorder)
• methoxsalen(used to treat skin disorders such as 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 drugssuch as acetylsalicylic acid and ibuprofen (used to treat pain and inflammation). These medicines should be avoided, especially at night.
• beta blockers(used to control blood pressure). These medicines should be taken in the morning.
• benzodiazepinesand non-benzodiazepine hypnoticssuch as zaleplon, zolpidem, and zopiclone (used to induce sleep)
• thioridazine(used to treat schizophrenia)
• imipramine(used to treat depression)

Tobacco

Tobacco can increase the breakdown of melatonin by the liver, which may make this medicine less effective. Inform your doctor if your child starts or stops smoking during treatment.

Taking Slenyto with alcohol

Do not drink alcohol before, during, or after taking Slenyto, as alcohol can weaken the effect of this medicine.

Pregnancy and breastfeeding

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 starting to take Slenyto if your child:

• is pregnant or might be pregnant. As a precaution, it is preferable 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 child should breastfeed while taking melatonin.

Driving and using machines

Slenyto can cause drowsiness. After taking this medicine, your child should not drive a vehicle, ride a bicycle, or use machines until they have fully recovered.

If your child experiences continuous drowsiness, they should consult their doctor.

Slenyto contains lactose

Slenyto contains lactose monohydrate. If your doctor has told your child that they have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Slenyto

Follow exactly the administration instructions of this medicine given by your doctor.

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

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

Insomnia in children and adolescents (from 2 to 18 years of age) with ASD and/or neurogenetic disorders (hereditary disorders that affect 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 child's symptoms do not improve, your doctor may increase the dose of Slenyto to determine the most suitable dose for your child. The maximum daily dose that your child will receive is 10 mg (two 5 mg tablets).

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

Insomnia in children and adolescents (from 6 to 17 years of age) 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 child's symptoms, the dose can be individually adjusted to 5 mg daily, regardless of age. If the doctor considers it necessary, the maximum daily dose can be increased to 10 mg (two 5 mg tablets) per day.

The lowest possible dose will be used for the shortest possible time.

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

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

When to take Slenyto

Slenyto should be taken at night, 30 to 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 should be swallowed whole, without being broken, crushed, or chewed. If the tablets are crushed or chewed, their special properties will be altered and they will not work correctly.

Whole 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 should be administered 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 your child takes more Slenyto than they should

If your child has accidentally taken too much medicine, contact their doctor or pharmacist as soon as possible.

Taking more than the recommended daily dose may cause your child to feel drowsy.

If your child forgets to take Slenyto

If your child forgets to take a tablet, they can take it before bedtime that night, but after that time, no more tablets should be taken until the next night.

Do not take a double dose to make up for forgotten doses.

If your child stops taking Slenyto

Consult your doctor before your child stops taking Slenyto. It is important to continue taking this medicine to treat the disorder.

If you have any other questions about the use of this medicine, ask 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 behavior, such as aggression (may affect up to 1 in 10 people), can occur frequently. If this change in behavior occurs, you should inform your doctor. It is possible that the doctor will want your child to stop taking this medicine.

If any of the following side effects become serious or troublesome, contact your doctor or seek medical attention:

Common: may affect up to 1 in 10 people

• mood changes
• aggression
• irritability
• drowsiness
• headache
• sudden sleepiness
• swelling and inflammation of the breasts associated with pain and nasal congestion (sinusitis)
• fatigue
• hangover sensation

Frequency not known(reported from use in adults)

• epilepsy
• visual impairment
• shortness of breath/difficulty breathing (dyspnea)
• nosebleeds (epistaxis)
• constipation
• loss of appetite
• facial swelling
• skin injury
• abnormal sensation
• abnormal behavior
• low white blood cell count (neutropenia)

Reporting of side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Slenyto

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 is the last day of the month stated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Slenyto Composition

Dose of 1 mg

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

Product Appearance and Package Contents

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 certain package sizes may be marketed.

Marketing Authorization Holder

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux

75002 Paris

France

Email: regulatory@neurim.com

Manufacturer

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:

Date of the Last Revision of this Leaflet: {month/YYYY}

Other Sources of Information

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