Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · BiResp Spiromax

BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder · Abschnitt 4.8 · PDF-Seite 10

HOS-221148 · Präparat HOS-216790

Since BiResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.