Abbreviated Prescribing Information
Xigduo XR

Presentation: dapagliflozin propanediol monohydrate/metformin hydrochloride extended-release tablets. Indications: (1) An adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. (2) In adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure. Dosage and Administration: One tablet to be swallowed whole, once daily with evening meal. For initial therapy, dapagliflozin 10 mg and metformin extended-release 500 mg to be taken once daily, with metformin extended-release titratable to 2000 mg once daily. For add on combination therapy, dapagliflozin 10 mg and metformin extended-release at the dose already being taken, or the nearest therapeutically appropriate dose taken once daily. The maximum dose is dapagliflozin 10 mg/metformin extended-release 2000 mg once daily. If no adequate strength of XIGDUO XR is available, individual mono-components should be used instead. Contraindications: Hypersensitivity to dapagliflozin, metformin HCl or excipients. Diabetic ketoacidosis, diabetic pre-coma. eGFR persistently <45 mL/min/1.73². Acute conditions that potentially alter renal function such as: dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents. Acute or chronic diseases which may cause tissue hypoxia such as: cardiac or respiratory failure, pulmonary embolism, recent MI, shock, acute significant blood loss, sepsis, gangrene, pancreatitis. During or immediately following surgery where insulin is essential, elective major surgery. Hepatic impairment. Acute alcohol intoxication. Alcoholism. Pregnancy and lactation. Precautions:  Lactic acidosis. Renal impairment. Hepatic impairment. Intravascular administration of iodinated contrast materials. Acute hypoxic conditions. Surgery. Risk of volume depletion or hypotension. Urinary tract infections. Vitamin B12 decrease/deficiency. Excessive alcohol intake. Ketoacidosis. Risk of hypoglycemia. Concomitant insulin, sulphonylurea or ethanol. Pregnancy and lactation. Elderly. Interactions: Rifampicin. Mefenamic acid. Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin). Frusemide. Nifedipine. Lithium. Undesirable effects: Dapagliflozin: Hypoglycaemia. Genital infection. Diabetic ketoacidosis. Metformin: Mild gastrointestinal symptoms (such as diarrhoea, nausea, vomiting, abdominal pain and loss of appetite). Taste disturbance. Full local prescribing information is available upon request. API.HK.XIG.0624.

HK-12359 17/10/2025