Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile

The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 children.

Tabulated list of adverse reactions

Adverse reactions are listed according to MedDRA system organ class and frequency category.
Frequency categories are defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Class                                       Common
Psychiatric disorders                 Mood swings, Aggression, Irritability Nervous system disorders              Somnolence, Headache, Sudden onset of sleep Respiratory, thoracic and             Sinusitis mediastinal disorders
General disorders and                 Fatigue, Hangover administration site conditions

The following adverse reactions (frequency unknown) have been reported with off-label use of the adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal behaviour and neutropenia.

Furthermore, in ASD and neurogenetic children treated with 2-6 mg of the adult formulation under a Temporary Recommendation for Use (RTU) program in France (N=731), the following additional adverse reactions (frequency uncommon) have been reported: depression, nightmares, agitation and abdominal pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form:
/https://sideeffects.health.gov.il