Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Cholib

Cholib 145 mg/20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-126950 · Präparat HOS-096355

• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4) • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen • Active liver disease or unexplained persistent elevations of serum transaminases • Known gallbladder disease • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia • Moderate to severe renal insufficiency (estimated glomerular filtration rate < 60 mL/min/1.73 m2) • Concomitant administration of potent CYP3A4 inhibitors (agents that increase AUC approximately 5 fold or greater) (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and medicinal products containing cobicistat) (see sections 4.4 and 4.5) • Concomitant administration of gemfibrozil, ciclosporin, or danazol (see sections 4.4 and 4.5) • Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5) • Paediatric population (age below 18 years) • Pregnancy and breast-feeding (see section 4.6) • Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4)

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ketoprofen (HOS-089671) nefazodone (HOS-084519) nelfinavir (HOS-084520) protease (HOS-085623) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) cobicistat (HOS-088111) creatine (HOS-123819) gemfibrozil (HOS-088403) glecaprevir (HOS-086297) voriconazole (HOS-084524) telaprevir (HOS-090618) telithromycin (HOS-084523) itraconazole (HOS-084516) danazol (HOS-085473) boceprevir (HOS-090617) clarithromycin (HOS-084517) erythromycin (HOS-084514) posaconazole (HOS-085622)