There have been significant updates to several sections of the SPC, including the following:
Change to section 4.2-Posology and method of administration
No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.
Please refer to SPC link below for full information on all changes