Nebenwirkungen · Daxas
Daxas 500 micrograms film-coated tablets · Abschnitt 4.8 · PDF-Seite 20
HOS-122877 · Präparat HOS-095587
A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA. Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-07T12:30:00Z · SHA-256 c9483b9b45da34f36b9555fd877e4e90626a238a341771b848d1c6fda96d3345 · Passage b73431fd2ef7ea720ae8f4384f5686aef61c49b73557c9c027e8619c8e1b0fda · Zeichen 4934–5539 im Abschnitt