Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Synjardy 5 mg/850 mg film-coated tablets.
Synjardy 5 mg/1,000 mg film-coated tablets.
Synjardy 12.5 mg/850 mg film-coated tablets.
Synjardy 12.5 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Synjardy 5 mg/850 mg film-coated tablets: Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). Synjardy 5 mg/1,000 mg film-coated tablets: Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). Synjardy 12.5 mg/850 mg film-coated tablets: Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm). Synjardy 12.5 mg/1,000 mg film-coated tablets: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm). |
Synjardy 5 mg/850 mg film-coated tablets: Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Synjardy 5 mg/1,000 mg film-coated tablets: Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Synjardy 12.5 mg/850 mg film-coated tablets: Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Synjardy 12.5 mg/1,000 mg film-coated tablets: Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
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. |
|
| 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 Empagliflozin |
Combination of two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: empagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and metformin hydrochloride, a member of the biguanide class. |
| List of Excipients |
|---|
Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tabletsTablet core: Maize starch Film-coating: Hypromellose Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tabletsTablet core: Maize starch Film-coating: Hypromellose |
PVC/PVDC/aluminium perforated unit dose blisters.
Pack sizes of 10 × 1, 14 × 1, 30 × 1, 56 × 1, 60 × 1, 90 × 1 and 100 × 1 film-coated tablets and multipacks containing 120 (2 packs of 60 × 1), 180 (2 packs of 90 × 1) and 200 (2 packs of 100 × 1) film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Synjardy 5 mg/850 mg film-coated tablets:
EU/1/15/1003/001
EU/1/15/1003/002
EU/1/15/1003/003
EU/1/15/1003/004
EU/1/15/1003/005
EU/1/15/1003/037
EU/1/15/1003/006
EU/1/15/1003/007
EU/1/15/1003/008
EU/1/15/1003/009
Synjardy 5 mg/1,000 mg film-coated tablets:
EU/1/15/1003/010
EU/1/15/1003/011
EU/1/15/1003/012
EU/1/15/1003/013
EU/1/15/1003/014
EU/1/15/1003/038
EU/1/15/1003/015
EU/1/15/1003/016
EU/1/15/1003/017
EU/1/15/1003/018
Synjardy 12.5 mg/850 mg film-coated tablets:
EU/1/15/1003/019
EU/1/15/1003/020
EU/1/15/1003/021
EU/1/15/1003/022
EU/1/15/1003/023
EU/1/15/1003/039
EU/1/15/1003/024
EU/1/15/1003/025
EU/1/15/1003/026
EU/1/15/1003/027
Synjardy 12.5 mg/1,000 mg film-coated tablets:
EU/1/15/1003/028
EU/1/15/1003/029
EU/1/15/1003/030
EU/1/15/1003/031
EU/1/15/1003/032
EU/1/15/1003/040
EU/1/15/1003/033
EU/1/15/1003/034
EU/1/15/1003/035
EU/1/15/1003/036
Date of first authorisation: 27 May 2015
Date of latest renewal: 01 April 2020
| Drug | Countries | |
|---|---|---|
| SYNJARDY | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, 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.
