Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Xigduo 5 mg/850 mg film-coated tablets.
Xigduo 5 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Xigduo 5 mg/850 mg film-coated tablets: Brown, biconvex, 9.5 × 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side. Xigduo 5 mg/1,000 mg film-coated tablets: Yellow, biconvex, 10.5 × 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side. |
Xigduo 5 mg/850 mg film-coated tablets: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
Xigduo 5 mg/1,000 mg film-coated tablets: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Excipient(s) with known effect: Xigduo contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dapagliflozin |
Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. |
|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Dapagliflozin |
Combination fo two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class. |
| List of Excipients |
|---|
|
Tablet core: Hydroxypropyl cellulose (E463) Film-coating: Xigduo 5 mg/850 mg film-coated tablets: Polyvinyl alcohol (E1203) Xigduo 5 mg/1,000 mg film-coated tablets: Polyvinyl alcohol (E1203) |
PVC/PCTFE/Alu blister.
Pack sizes:
14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
60 × 1 film-coated tablets in perforated unit dose blisters.
Multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Xigduo 5 mg/850 mg film-coated tablets:
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets
EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets
EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablets
EU/1/13/900/005 Xigduo 5 mg/850 mg 60 × 1 tablet (unit dose)
EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 × 98) tablets (multipack)
Xigduo 5 mg/1,000 mg film-coated tablets:
EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets
EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets
EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets
EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 × 1 tablet (unit dose)
EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 × 98) tablets (multipack)
Date of first authorisation: 16 January 2014
Date of latest renewal: 28 September 2018
| Drug | Countries | |
|---|---|---|
| XIGDUO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
