Equfina Overdosage

OVERDOSE AND TREATMENT: There is no apparent human experience with safinamide overdose.
Of note, 2 patients have taken 200 mg/day of safinamide. Of them, 1 experienced fall, nausea, and freezing phenomenon, and the other experienced confusional state, somnolence, and memory impairment. However, both subjects recovered. In addition, of 12 subjects who continuously received safinamide 300 mg/day for approximately 6 weeks, 4 experienced serious adverse events of macular edema, colitis ulcerative, rib fracture, and eczema, and these events were assessed as not related to safinamide, except for macular edema. All the events, excluding colitis ulcerative, were recovered.
There is no known antidote to safinamide nor any specific treatment for safinamide overdose. If an overdose occurs, safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated. In cases of overdose with safinamide, dietary tyramine restriction should be observed for several weeks.