Nebenwirkungen · Rozlytrek
Rozlytrek 50 mg film-coated granules in sachet · Abschnitt 4.8 · PDF-Seite 48–49
HOS-143091 · Präparat HOS-098918
48 (0.2%), visual hallucination (0.2%), auditory hallucination (0.1%), mental impairment (0.1%) and mental disorder (0.1%). Grade 3 cognitive disorders were reported in 3.6% of patients. Adult patients who had central nervous system (CNS) disease at baseline had a higher frequency of these adverse reactions (30%) compared to those without CNS disease (22.6%). The median time to onset for cognitive disorders was 0.95 months. In the paediatric population, 2.2% (2/91) of patients experienced disturbance in attention of Grade 1 severity and 2.2% (2/91) of patients experienced disturbance in attention of Grade 2 severity.
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