Slenyto® offers favorable safety, both under short and long term treatment
The safety profile of Slenyto® has been well characterized during the multi-national two- years Phase III clinical trial program.
Favorable safety profile was shown both short and long term. Fatigue, moodswings, headache, irritability, aggression and hangover occurred in 1:10-1:100 children. Overall, similar treatment-related side effects in Slenyto® and placebo groups, except mild to moderate somnolence, which was more common with Slenyto®. The occurrence of side effects was lower with long term use of Slenyto® and there were no reports of dependence, abuse, tolerance, withdrawal or rebound.
In fact, compliance with the mini-tablets was close to 100% throughout the 24 months study.
Concomitant use of Slenyto® with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, thioridazine and imipramine is not recommended.While concomitant use with 5- or 8-methoxypsoralen, Cimetidine, Oestrogens, CYP1A2 inhibitors, CYP1A2 inducers, tobacco products, should be considered with caution.
Prostaglandin synthesis inhibitors (NSAIDs) and Beta-blocker products may affect endogenous melatonin levels and therefore their adminstration with Slenyto® should be avoided in the evening and administered in the morning.
Hypersensitivity to the active substance or to any excipients listed in the prescribing information. For example, Slenyto® contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.