International Name

Dapagliflozin

International Nonproprietary Name (INN)

Dapagliflozin

Composition

Each tablet contains:

• 12.30 mg dapagliflozin propanediol (equivalent to 10 mg dapagliflozin)

Excipients

Tablet core:

• Microcrystalline cellulose (E460i)

• Lactose

• Crospovidone (E1201)

• Colloidal silicon dioxide (E551)

• Magnesium stearate (E470b)

Coating composition:

• Polyvinyl alcohol, partially hydrolyzed (E1203)

• Titanium dioxide (E171)

• Macrogol 3350

• Talc (E553b)

• Iron oxide yellow (E172)

Dosage and Administration

Dosage:

• Recommended dose for monotherapy or in combination with other glucose-lowering medications: 10 mg once daily

• When used with insulin or insulin secretagogues: a lower dose of insulin or secretagogue may be needed to reduce the risk of hypoglycemia

Administration:

• Dapagliflozin is taken orally, once daily, at any time of day, with or without food

• Tablets should be swallowed whole

Special Populations

• Renal Impairment: The effectiveness of dapagliflozin depends on kidney function

• Effectiveness is reduced in patients with moderate renal impairment

• Use of dapagliflozin is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 60 mL/min or glomerular filtration rate < 60 mL/min/1.73 m²)

• Dose adjustment is not indicated in mild renal impairment

Contraindications

• Hypersensitivity to the active substance or any of the excipients