GLYXAMBI Film-coated tablet Ref.[50815] Active ingredients: Empagliflozin Linagliptin Linagliptin and Empagliflozin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany

Product name and form

Glyxambi 10 mg/5 mg film-coated tablets.

Glyxambi 25 mg/5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Glyxambi 10 mg/5 mg film-coated tablets: Pale yellow, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side).

Glyxambi 25 mg/5 mg film-coated tablets: Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side).

Qualitative and quantitative composition

Glyxambi 10 mg/5 mg film-coated tablets: Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.

Glyxambi 25 mg/5 mg film-coated tablets: Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.

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.

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.

Linagliptin and Empagliflozin

Antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes. Linagliptin is an inhibitor of DPP-4 an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2.

List of Excipients

Glyxambi 10 mg/5 mg film-coated tablets

Tablet core:

Mannitol (E421)
Pre-gelatinised starch (maize)
Maize starch
Copovidone (K-value nominally 28)
Crospovidone (Type B)
Talc
Magnesium stearate

Film coating:

Hypromellose 2910
Mannitol (E421)
Talc
Titanium dioxide (E171)
Macrogol 6000
Iron oxide yellow (E172)

Glyxambi 25 mg/5 mg film-coated tablets

Tablet core:

Mannitol (E421)
Pre-gelatinised starch (maize)
Maize starch
Copovidone (K-value nominally 28)
Crospovidone (Type B)
Talc
Magnesium stearate

Film coating:

Hypromellose 2910
Mannitol (E421)
Talc
Titanium dioxide (E171)
Macrogol 6000
Iron oxide red (E172)

Pack sizes and marketing

PVC/PVDC/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.

Marketing authorization holder

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

Marketing authorization dates and numbers

Glyxambi 10 mg/5 mg film-coated tablets:

EU/1/16/1146/001 (7 × 1 film-coated tablets)
EU/1/16/1146/002 (10 × 1 film-coated tablets)
EU/1/16/1146/003 (14 × 1 film-coated tablets)
EU/1/16/1146/004 (28 × 1 film-coated tablets)
EU/1/16/1146/005 (30 × 1 film-coated tablets)
EU/1/16/1146/006 (60 × 1 film-coated tablets)
EU/1/16/1146/007 (70 × 1 film-coated tablets)
EU/1/16/1146/008 (90 × 1 film-coated tablets)
EU/1/16/1146/009 (100 × 1 film-coated tablets)

Glyxambi 25 mg/5 mg film-coated tablets:

EU/1/16/1146/010 (7 × 1 film-coated tablets)
EU/1/16/1146/011 (10 × 1 film-coated tablets)
EU/1/16/1146/012 (14 × 1 film-coated tablets)
EU/1/16/1146/013 (28 × 1 film-coated tablets)
EU/1/16/1146/014 (30 × 1 film-coated tablets)
EU/1/16/1146/015 (60 × 1 film-coated tablets)
EU/1/16/1146/016 (70 × 1 film-coated tablets)
EU/1/16/1146/017 (90 × 1 film-coated tablets)
EU/1/16/1146/018 (100 × 1 film-coated tablets)

Date of first authorisation: 11 November 2016
Date of latest renewal: 16 July 2021

Drugs

Drug Countries
GLYXAMBI Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Lithuania, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States

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