DAPAGLIFLOZIN SANDOZ FILM COATED TABLET 10MG [SIN17199P]

Product Info

DAPAGLIFLOZIN SANDOZ FILM COATED TABLET 10MG

[SIN17199P]

Indication

4.1 Therapeutic indications
Type 2 diabetes mellitus
DAPAGLIFLOZIN SANDOZ is indicated in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. DAPAGLIFLOZIN SANDOZ can be given as monotherapy or in combination with other medicinal products indicated for the treatment of type 2 diabetes mellitus.

For study results with respect to combination of therapies, effects on glycemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Chronic kidney disease
DAPAGLIFLOZIN SANDOZ is indicated as an adjunct to standard therapy to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular (CV) death in adults with chronic kidney disease at risk of progression.

DAPAGLIFLOZIN SANDOZ is not indicated for use in patients with type 1 diabetes.

DAPAGLIFLOZIN SANDOZ should not be used for the treatment of diabetic ketoacidosis.

Dosing

4.2 Posology and method of administration
Type 2 diabetes mellitus
The recommended dose of DAPAGLIFLOZIN SANDOZ is 10 mg taken orally once daily at any time of the day regardless of meals.

Chronic kidney disease
The recommended dose of DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ is reduced in patients with eGFR <45 mL/min/1.73m² (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/1.73m², additional glucose lowering treatment should be considered in patients with diabetes mellitus.

Patients with hepatic impairment
No dosage adjustment for DAPAGLIFLOZIN SANDOZ is necessary for patients with mild and moderate hepatic impairment. DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ in pediatric and adolescent patients have not been established.

Geriatric patients
No dosage adjustment for DAPAGLIFLOZIN SANDOZ 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).

Contraindications

4.3 Contraindications
DAPAGLIFLOZIN SANDOZ is contraindicated in patients with a history of any serious hypersensitivity reaction to the active substance or to any of the excipients.