Aprepilor Trio Special Precautions

Patients with moderate to severe hepatic impairment: There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. APREPILOR TRIO should be used with caution in these patients (see Pharmacology: Pharmacokinetics under Actions).
CYP3A4 interactions: APREPILOR TRIO should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergot alkaloid derivatives, fentanyl, and quinidine (see Interactions). Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Co-administration with warfarin (a CYP2C9 substrate): In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely during treatment with APREPILOR TRIO and for 14 days following each 3-day course of APREPILOR TRIO (see Interactions).
Co-administration with hormonal contraceptives: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of APREPILOR TRIO. Alternative non-hormonal back-up methods of contraception should be used during treatment with APREPILOR TRIO and for 2 months following the last dose of APREPILOR TRIO (see Interactions).
Excipients: APREPILOR TRIO capsules contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Sodium: APREPILOR TRIO contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: APREPILOR TRIO may have minor influence on the ability to drive, cycle and use machines. Dizziness and fatigue may occur following administration of APREPILOR TRIO (see Adverse Reactions).