BETMIGA ® PROLONGED-RELEASE TABLETS 50MG

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED, EXTENDED RELEASE

**4.2 Posology and method of administration** Posology _Adults (including elderly patients)_ The recommended starting dose of Betmiga is 25 mg once daily. Based on individual patient efficacy and tolerability the dose may be increased to 50mg once daily. Betmiga can be taken with or without food. _Special populations_ _Renal and hepatic impairment_ No dose adjustment is necessary in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2 as estimated by MDRD). In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), the recommended dose is 25 mg dose once daily with or without food. Betmiga has not been studied in patients with End Stage Renal Disease (eGFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). In patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dose is 25 mg once daily with or without food. Betmiga has not be studied in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Gender_ No dose adjustment is necessary according to gender. _Paediatric population_ The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available. Method of administration The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.