Dapagliflozin (Sandoz) TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: dapagliflozin
Pack: Dapagliflozin (Sandoz) 10 mg tablet, 28, blister pack
Brand name
(ARTG)
: DAPAGLIFLOZIN SANDOZ dapagliflozin 10 mg film coated tablet blister packWhat this medicine is used for
(ARTG)
Type 2 diabetes mellitus,Glycaemic control Dapagliflozin Sandoz is indicated in adults with type 2 diabetes mellitus: as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c [HbA1c] levels). in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties Clinical trials and Section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).,Prevention of hospitalisation for heart failure Dapagliflozin Sandoz is indicated 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 (see Section 5.1 Pharmacodynamic properties Clinical trials).,Heart failure Dapagliflozin Sandoz is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see Section 5.1 Pharmacodynamic properties).,Chronic kidney disease Dapagliflozin Sandoz is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2,3 or 4) (see Section 5.1 Pharmacodynamic properties Clinical trials, Chronic kidney disease).
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Light yellow, oval, biconvex, film coated tablet, with debossment DN 10 on one side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 28 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient dapagliflozin
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
