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Xigduo XR 5/1000 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 + metformin

Brand name

(ARTG)

: XIGDUO XR 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

Glycaemic control: XIGDUO XR is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control when treatment with both dapagliflozin and metformin is appropriate,Prevention of hospitalisation for heart failure: XIGDUO XR 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 and 4.4 Special warnings and precautions for use for available data on the combination therapy).

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Tablet, modified release
  • Oral
  • Pink to dark pink, biconvex, oval-shaped, film-coated tablet with "1071" and "5/1000" debossed on one side and plain on the other side

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 24 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 14 tablets (sample pack) pack
  • 56 tablets pack

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on November, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient dapagliflozin + metformin

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

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