JARDIANCE FILM-COATED TABLETS 10MG

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** Posology _Type 2 diabetes mellitus_ _Monotherapy and add-on combination_ The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg (see below and section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Heart failure (HF)_ The recommended dose of JARDIANCE is 10 mg once daily (see clinical trial section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Chronic kidney disease_ The recommended dose of JARDIANCE is 10 mg once daily (see clinical trial section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Special populations_ _Renal impairment_ Due to limited experience, it is not recommended to initiate treatment with JARDIANCE in patients with an eGFR <20 ml/min/1.73 m2. Glycaemic efficacy of empagliflozin is dependent on renal function and reduced in patients with an eGFR <45 ml/min/1.73 m2 and likely absent in patients with an eGFR<30 ml/min/1.73 m2. **If eGFR falls below 45 ml/min/1.73 m2 the recommended dose of empagliflozin is limited to 10 mg and additional glucose lowering treatment should be considered if needed** (see Special warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ No dose adjustment is required for patients with hepatic impairment. Empagliflozin exposure is increased in patients with severe hepatic impairment. Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly patients_ No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of empagliflozin in children and adolescents has not yet been established. No data are available. Method of administration The tablets can be taken with or without food, swallowed whole with water. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.