Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-130362 · Präparat HOS-096899

Gastrointestinal adverse reactions The vast majority of subjects treated with naltrexone/bupropion who experienced nausea reported the event within 4 weeks of starting treatment. Events were generally self-limited; the majority of events resolved within 4 weeks and almost all resolved by week 24. Similarly, the majority of events of constipation in subjects treated with naltrexone/bupropion were reported during the dose escalation phase. The time to resolution of constipation was similar between subjects treated with naltrexone/bupropion and subjects treated with placebo. Approximately half of the subjects treated with naltrexone/bupropion who experienced vomiting first reported the event during the dose escalation phase. Time to resolution for vomiting was typically rapid (within one week) and almost all events resolved within 4 weeks. The incidence of these common gastrointestinal adverse reactions in naltrexone/bupropion versus placebo was as follows: nausea (31.8% vs. 6.7%), constipation (18.1% vs. 7.2%), and vomiting (9.9% vs. 2.9%). The incidence of severe nausea, severe constipation, and severe vomiting was low, but was higher in subjects treated with naltrexone/bupropion compared to subjects treated with placebo (severe nausea: naltrexone/bupropion (1.9%), placebo (<0.1%); severe constipation: naltrexone/bupropion (0.6%), placebo (0.1%); severe vomiting: naltrexone/bupropion (0.7%), placebo (0.3%)). No events of nausea, constipation, or vomiting were considered serious.

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