SLENYTO 1 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Slenyto 1 mg prolonged-release tablets, 5 mg prolonged-release tablets
   1. What is Slenyto and what is it used for
   2. What you need to know before you or your child take Slenyto
   3. How to take Slenyto
   4. Possible side effects
   5. How to store Slenyto
   6. Package contents and other information

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

melatonin

Read this leaflet carefully before you or your child takes this medicine,
because it contains important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if they have the same symptoms as you or your child, as it could be dangerous.
• If you or your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Slenyto and what is it used for

What is Slenyto
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 used for the treatment of insomnia(inability to sleep) in:

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

Slenyto shortens the time it takes to fall asleep and prolongs the duration of sleep. The
medicine may help you or your child to fall asleep and sleep longer during the
night.

2. What you need to know before you or your child take 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 and precautions
Talk to your doctor or pharmacist before taking Slenyto if you or your child:

• suffer from liver or kidney problems. Talk to your doctor before taking/giving Slenyto as its use is not recommended in such cases.
• suffer from an autoimmune disease (where the body attacks its own immune system). Talk to your doctor before taking/giving Slenyto as its use is not recommended in such cases.

Slenyto may cause drowsiness and daytime fatigue. Caregivers must monitor the child
for any signs of daytime fatigue and, if these symptoms occur, contact
the doctor for guidance.
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
Tell your doctor or pharmacist if you or your child is taking, has recently taken or
may take any other medicine.
In particular, taking Slenyto with the following medicines may increase the risk of side
effects, or may affect the functioning of Slenyto or the other medicines:

• fluvoxamine(used for the treatment of depression and obsessive-compulsive disorder)
• methoxpsoralenes(used in the treatment of skin disorders, such as psoriasis)
• cimetidine(used for the treatment of stomach problems such as ulcers)
• quinolones(for example ciprofloxacin and norfloxacin) and rifampicin(used for the treatment of bacterial infections)
• estrogens(used in contraceptives or hormone replacement therapy)
• carbamazepine(used for the treatment of epilepsy)
• non-steroidal anti-inflammatory drugssuch as aspirin and ibuprofen (used for the treatment of 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 hypnoticssuch as zaleplon, zolpidem and zopiclone (used to induce sleep )
• thioridazine(used for the treatment of schizophrenia)
• imipramine(used for the treatment of depression)

Smoking
Smoking may increase the degradation of melatonin by the liver, which may decrease
the effectiveness of the medicine. Talk to your doctor if you or your child starts or stops smoking
during treatment.

Slenyto with 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Talk to your doctor or pharmacist before taking Slenyto if you or your daughter:

• is or may be pregnant. As a precaution, it is preferable to avoid the use of melatonin during pregnancy;
• is breastfeeding or planning to breastfeed. It is possible for melatonin to be transferred into breast milk, so 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 use machines until fully recovered.
If you or your child experiences persistent drowsiness, you should consult a doctor.

Slenyto contains lactose
Slenyto contains lactose monohydrate. If your doctor has diagnosed you or your child with
intolerance to certain sugars, contact them before taking this medicine.

3. How to take Slenyto

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Slenyto is available in two dosages: 1 mg and 5 mg.

Insomnia in children and adolescents (aged between 2 and 18 years) with DSA and/or
neurogenetic diseases (hereditary conditions affecting the nerves and brain) associated with
abnormal levels of melatonin and/or nocturnal awakenings.
The recommended starting dose is 2 mg (two 1 mg tablets) once a day. If you/your child do not
experience any improvement in symptoms, your doctor may increase the dose of
Slenyto to identify the one most suitable for you/your child. The maximum daily dose that you/your
child will receive is 10 mg (two 5 mg tablets).
You/your child will be monitored by the doctor at regular intervals (recommended every 6 months) to
verify that Slenyto is still the correct treatment for you/the 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 a day. If
there is no improvement in symptoms for you/your child, the dose may be adjusted
individually to 5 mg per day, regardless of age. If the doctor deems 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.
You/your child must be monitored by the doctor at regular intervals (recommended every
6 months) to verify that Slenyto is still the appropriate treatment for you/your child.
Treatment should be discontinued once a year to establish if it is still necessary.
When to take Slenyto
Slenyto should be taken in the evening, 30 to 60 minutes before bedtime. The tablets should be
taken after dinner, i.e. on a full stomach.
How to take Slenyto
Slenyto is for oral use. The tablets MUST NOT be split, crushed or
chewed, but must be swallowed whole.Chewing and crushing damage the
particular properties of the tablet, reducing its effectiveness.

Whole tabletscan be introduced into foods such as yogurt, orange juice or ice cream to
facilitate swallowing. If the tablets are mixed with these foods, they must be
administered immediately and not set aside or stored, as this may compromise their
effectiveness. Introducing the tablets into other types of food may compromise their effectiveness.

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

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

If you or your child stops taking Slenyto
Contact your doctor before stopping you or your child's treatment with Slenyto. It is
important to continue taking this medicine for the treatment of the disorder.
If you have any further 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.
Unexpected changes in behaviour, such as aggression, can occur commonly
(affecting from 1 in 100 to 1 in 10 people). If this change in
behaviour occurs, contact your doctor. Your doctor may ask you/your child to
stop taking the medicine.
If any of the following side effects should worsen or become troublesome, contact your doctor.

Common: may affect from 1 in 100 to 1 in 10 people

• Mood swings
• Aggression
• Irritability
• Drowsiness
• Headache
• Sudden sleepiness
• Swelling and inflammation of the sinuses associated with pain and nasal congestion (sinusitis)
• Fatigue
• Feeling of hangover

Uncommon:may affect from 1 in 1,000 to 1 in 100 people

• Depression
• Nightmares
• Agitation
• Stomach pain

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

• Convulsions (epilepsy)
• Visual disturbances
• Shortness of breath/difficulty breathing (dyspnea)
• Nosebleed (epistaxis)
• Constipation
• Decreased appetite
• Facial edema
• Skin lesions
• Feeling of abnormality
• Abnormal behaviour
• Low levels of white blood cells (leukopenia)

Reporting of side effects
If you or your child gets any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system listed in Appendix V. By reporting side effects you can help to
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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 dosage

• The active ingredient is melatonin. Each tablet contains 1 mg of melatonin.
• The other ingredients 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), red iron oxide (E172) and yellow iron oxide (E172).

5 mg dosage

• The active ingredient is melatonin. Each tablet contains 5 mg of melatonin.
• The other ingredients 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 yellow iron oxide (E172).

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

Marketing authorisation 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 on this medicinal product, contact the local representative of the marketing authorisation holder:

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

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

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

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

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

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

Danmark
Takeda Pharma A/S
e-mail: [email protected]

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

Deutschland
INFECTOPHARM Arzneimittel und Consilium
GmbH
Tel: +49 6252 957000
e-mail: [email protected]

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

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

Norge
Takeda AS
e-mail: [email protected]

Ελλάδα
INNOVIS PHARMA A.E.B.E.
Τηλ: +30 216 200 5600
e-mail: [email protected]

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

España
EXELTIS HEALTHCARE, S.L.
Tel: +34 91 7711500
e-mail: [email protected]

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

France
BIOCODEX
Tél: +33 (0)1 41 24 30 00
e-mail: [email protected]

Portugal
Laboratórios Azevedos – Indústria Farmacêutica,
S.A.
Tel: +351 214 725 900
e-mail: [email protected]

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

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

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

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

Ísland
Williams & Halls ehf.
Sími: +354 527 0600
Netfang: [email protected]

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

Italia
Fidia Farmaceutici S.p.A.
Tel: +39 049 8232222
e-mail: [email protected]

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

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

Sverige
Takeda Pharma AB
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