Safety-Related Labeling Changes

Patients with renal impairment Vitamin B12 decrease , use in patients with heart failure with reduced ejection fraction and in patients with chronic kidney disease Concomitant use of dapagliflozin and lithium

Trade Name

Xigduo XR

Updated Section

4.4 Special warnings and special precautions for use 4.8 Undesirable effects 4.5 Interaction with other medicinal products and other forms of interaction

Month

Aug, 2025