Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany
Jentadueto 2.5 mg/850 mg film-coated tablets.
Jentadueto 2.5 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Jentadueto 2.5 mg/850 mg film-coated tablets: Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with “D2/850” on one side and the company logo on the other. Jentadueto 2.5 mg/1,000 mg film-coated tablets: Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with “D2/1000” on one side and the company logo on the other. |
Jentadueto 2.5 mg/850 mg film-coated tablets: Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Jentadueto 2.5 mg/1,000 mg film-coated tablets: Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Linagliptin |
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. |
|
| 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 Linagliptin |
Combination of two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. |
| List of Excipients |
|---|
|
Tablet core: Arginine Jentadueto 2.5 mg/850 mg film-coated tablets: Film coating: Hypromellose Jentadueto 2.5 mg/1,000 mg film-coated tablets: Film coating: Hypromellose |
Pack sizes of 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1 and 120 × 1 film-coated tablets and multipacks containing 120 (2 packs of 60 × 1), 180 (2 packs of 90 × 1), 180 (3 packs of 60 × 1) and 200 (2 packs of 100 × 1) film-coated tablets in aluminium lidding foil and PVC/polychlorotrifluoro ethylene/PVC based forming foil perforated unit dose blisters.
High-Density PolyEthylene (HDPE) bottle with plastic screw cap and a seal liner (aluminiumpolyester foil laminate) and a silica gel desiccant. Pack sizes of 14, 60 and 180 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany
Jentadueto 2.5 mg/850 mg film-coated tablets:
EU/1/12/780/001 (10 × 1 film-coated tablets)
EU/1/12/780/002 (14 × 1 film-coated tablets)
EU/1/12/780/003 (28 × 1 film-coated tablets)
EU/1/12/780/004 (30 × 1 film-coated tablets)
EU/1/12/780/005 (56 × 1 film-coated tablets)
EU/1/12/780/006 (60 × 1 film-coated tablets)
EU/1/12/780/007 (84 × 1 film-coated tablets)
EU/1/12/780/008 (90 × 1 film-coated tablets)
EU/1/12/780/009 (98 × 1 film-coated tablets)
EU/1/12/780/010 (100 × 1 film-coated tablets)
EU/1/12/780/011 (120 × 1 film-coated tablets)
EU/1/12/780/012 (14 film-coated tablets, bottle)
EU/1/12/780/013 (60 film-coated tablets, bottle)
EU/1/12/780/014 (180 film-coated tablets, bottle)
EU/1/12/780/029 (120 (2 × 60 × 1) film-coated tablets)
EU/1/12/780/030 (180 (2 × 90 × 1) film-coated tablets)
EU/1/12/780/031 (200 (2 × 100 × 1) film-coated tablets)
EU/1/12/780/035 (180 (3 × 60 × 1) film-coated tablets)
Jentadueto 2.5 mg/1,000 mg film-coated tablets:
EU/1/12/780/015 (10 × 1 film-coated tablets)
EU/1/12/780/016 (14 × 1 film-coated tablets)
EU/1/12/780/017 (28 × 1 film-coated tablets)
EU/1/12/780/018 (30 × 1 film-coated tablets)
EU/1/12/780/019 (56 × 1 film-coated tablets)
EU/1/12/780/020 (60 × 1 film-coated tablets)
EU/1/12/780/021 (84 × 1 film-coated tablets)
EU/1/12/780/022 (90 × 1 film-coated tablets)
EU/1/12/780/023 (98 × 1 film-coated tablets)
EU/1/12/780/024 (100 × 1 film-coated tablets)
EU/1/12/780/025 (120 × 1 film-coated tablets)
EU/1/12/780/026 (14 film-coated tablets, bottle)
EU/1/12/780/027 (60 film-coated tablets, bottle)
EU/1/12/780/028 (180 film-coated tablets, bottle)
EU/1/12/780/032 (120 (2 × 60 × 1) film-coated tablets)
EU/1/12/780/033 (180 (2 × 90 × 1) film-coated tablets)
EU/1/12/780/034 (200 (2 × 100 × 1) film-coated tablets)
EU/1/12/780/036 (180 (3 × 60 × 1) film-coated tablets)
Date of first authorisation: 20 July 2012
Date of latest renewal: 22 March 2017
| Drug | Countries | |
|---|---|---|
| JENTADUETO | Austria, Canada, Cyprus, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom, United States |
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