JENTADUETO Film-coated tablet Ref.[10504] Active ingredients: Linagliptin Metformin Metformin and Linagliptin

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Copovidone
Magnesium stearate
Maize starch
Silica, colloidal anhydrous

Jentadueto 2.5 mg/850 mg film-coated tablets:

Film coating:

Hypromellose
Titanium dioxide (E171)
Talc
Yellow iron oxide (E172)
Red iron oxide (E172)
Propylene glycol

Jentadueto 2.5 mg/1,000 mg film-coated tablets:

Film coating:

Hypromellose
Titanium dioxide (E171)
Talc
Red iron oxide (E172)
Propylene glycol

Pack sizes and marketing

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.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
JENTADUETO Austria, Canada, Cyprus, Estonia, Spain, Finland, Ireland, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom, United States

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