FORXIGA TABLET 5MG

TABLET, FILM COATED

**4.2 Posology and method of administration** **Type 2 diabetes mellitus** The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals. **Heart failure** The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals. **Chronic kidney disease** The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals. **Special populations** _**Patients with renal impairment**_ No dosage adjustment is required based on renal function. Due to limited experience, it is not recommended to initiate treatment with FORXIGA in patients with GFR < 25 mL/min, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, end-stage kidney disease and CV death. The glucose lowering efficacy of FORXIGA is reduced in patients with eGFR <45 mL/min/1.73 m2 (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Therefore, if eGFR falls below 45 mL/min/1.73 m2, additional glucose lowering treatment should be considered in patients with diabetes mellitus. _**Patients with hepatic impairment**_ No dosage adjustment for FORXIGA is necessary for patients with mild and moderate hepatic impairment. FORXIGA should not be used in patients with severe hepatic impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Pediatric and adolescent patients**_ Safety and effectiveness of FORXIGA in pediatric and adolescent patients have not been established. _**Geriatric patients**_ No dosage adjustment for FORXIGA is required based on age (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Older patients are more likely to have impaired renal function. The renal function recommendations provided for all patients also apply to elderly patients (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).