SLENYTO 1 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, even if their symptoms are the same as your child's. It may harm them.
• If you or your child experience any side effects, talk to your doctor or pharmacist, even if it is 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 further 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 produced naturally by the body.

What is it 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 sleep duration.

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

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

Do not take Slenyto if you or your child:

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

Warnings and precautions

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

• have liver or kidney problems. Your doctor should be consulted before taking/administering Slenyto, as its use is not recommended in such cases.
• have an autoimmune disease (where the body's immune system attacks parts of the body). Your doctor should be consulted 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 it has not been tested and its effects are unknown.

Other medicines and Slenyto

Tell your doctor or pharmacist if you or your child are taking, have 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 may increase the breakdown of melatonin by the liver, which may make this medicine less effective. Tell your doctor if you or your child start or stop smoking during treatment.

Taking Slenyto with alcohol

Do not drink alcohol before, during, or after taking Slenyto, as alcohol weakens 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 you or your daughter:

• are pregnant or might be pregnant. As a precaution, it is preferable to avoid the use of melatonin during pregnancy.
• • are breastfeeding or plan 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 using machines

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

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

Slenyto contains lactose

Slenyto contains lactose monohydrate. If your doctor has told you or your child that you 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 daily. 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 you or your child will receive is 10 mg (two 5 mg tablets).

Your doctor should regularly monitor you or your child (it is recommended every 6 months) to check that Slenyto is still the suitable treatment for you or 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 daily. If there is no improvement in your child's symptoms, the dose may be individually adjusted 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 used for the shortest duration.

Your doctor should regularly monitor you or your child (it is recommended every 6 months) to check that Slenyto is still the suitable treatment for you or 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 must 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 placed in 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 you or your child take more Slenyto than you should

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

Taking more 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 after that time, do not take any more tablets until the next night.

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

If you or your child stop taking Slenyto

You should talk to your doctor before you or your child stop taking Slenyto. It is important to keep taking this medicine to treat the disorder.

If you have any further questions on the use of this product, 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), may occur. If this change in behavior occurs, you should inform your doctor. It is possible that your doctor will want you or your child to stop taking this medicine.

If any of the following side effects get serious or troublesome, talk to your doctor or seek medical attention:

Common: 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 congestion (sinusitis)
• fatigue
• feeling of hangover

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 you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via 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 refers to 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 some pack 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 Last Revision of this Leaflet: {month/YYYY}

Other Sources of Information

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