Posology : מינונים

4.2    Posology and method of administration

Posology
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.

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 (under 2 years of age)
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.