Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Jardiance 10 mg film-coated tablets.
Jardiance 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Jardiance 10 mg film-coated tablets: Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed with “S10” on one side and the Boehringer Ingelheim logo on the other (tablet diameter: 9.1 mm). Jardiance 25 mg film-coated tablets: Oval, pale yellow, biconvex film-coated tablet debossed with “S25” on one side and the Boehringer Ingelheim logo on the other (tablet length: 11.1 mm, tablet width: 5.6 mm). |
Each tablet contains 10 mg empagliflozin.
Excipients with known effect: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Each tablet contains 25 mg empagliflozin.
Excipients with known effect: Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Empagliflozin |
Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film coating: Hypromellose |
PVC/aluminium perforated unit dose blisters.
Pack sizes of 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1, and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Jardiance 10 mg film-coated tablets:
EU/1/14/930/010
EU/1/14/930/011
EU/1/14/930/012
EU/1/14/930/013
EU/1/14/930/014
EU/1/14/930/015
EU/1/14/930/016
EU/1/14/930/017
EU/1/14/930/018
Jardiance 25 mg film-coated tablets:
EU/1/14/930/001
EU/1/14/930/002
EU/1/14/930/003
EU/1/14/930/004
EU/1/14/930/005
EU/1/14/930/006
EU/1/14/930/007
EU/1/14/930/008
EU/1/14/930/009
Date of first authorisation: 22 May 2014
Date of latest renewal: 14 February 2019
| Drug | Countries | |
|---|---|---|
| JARDIANCE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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