SLENYTO Prolonged-release tablet Ref.[115048] Active ingredients: Melatonin

Posology

Insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD) and/or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings

The recommended starting dose is 2 mg of Slenyto. If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg.

Slenyto should be taken once daily, 0.5-1 hour before bedtime and with or after food.

Data are available for up to 2 years' treatment. The patient should be monitored at regular intervals (at least every 6 months) to check that Slenyto is still the most appropriate treatment. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. If a lower treatment effect is seen after titration to a higher dose, the prescriber should first consider a down-titration to a lower dose before deciding on a complete discontinuation of treatment.

If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose.

Insomnia in children and adolescents aged 6-17 years with ADHD

The recommended starting dose is 1-2 mg. The dose may be adjusted on an individual basis to 5 mg per day regardless of age of the child. If clinically needed, the maximum daily dose may be increased to 10 mg. The lowest effective dose should be taken for the shortest period. Slenyto should be taken once daily, 0.5-1 hour before bedtime and with or after food.

After approximately 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. The patient should be monitored regularly (at least every 6 months) to check that Slenyto is still the most appropriate treatment. During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly, at least once a year.

If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose.

Special populations

Renal impairment

The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied. Caution should be used when melatonin is administered to patients with renal impairment.

Hepatic impairment

There is no experience of the use of melatonin in patients with liver impairment. Therefore, melatonin is not recommended for use in patients with hepatic impairment (see section 5.2).

Paediatric population

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

There is no relevant use of melatonin in children aged 0 to 2 years for the treatment of insomnia.

Method of administration

Oral use. Tablets should be swallowed whole. The tablet should not be broken, crushed or chewed because it will lose the prolonged release properties.

Tablets can be put into food such as yoghurt, orange juice or ice-cream to facilitate swallowing and improve compliance. If the tablets are mixed with food or drink, they should be taken immediately and the mixture not stored.

If overdose occurs, drowsiness is to be expected. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is required.

3 years.

Do not store above 30°C.

Slenyto 1 mg prolonged-release tablets: PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 tablets or 60 tablets.

Slenyto 5 mg prolonged-release tablets: PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.