« Back to Medicines list

Glyxambi 25 mg/5 mg film-coated tablets

  • Name:

    Glyxambi 25 mg/5 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Empagliflozin, Linagliptin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/07/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 28/7/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Actilyse Active Ingredients Alteplase
Medicine Name Actilyse Cathflo 2 mg Active Ingredients Alteplase
Medicine Name APTIVUS 100 mg/ml oral solution Active Ingredients Tipranavir
Medicine Name Aptivus 250 mg soft capsules Active Ingredients Tipranavir
Medicine Name Atrovent 250 UDVs, 250 micrograms/1ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent Inhaler CFC-Free Active Ingredients ipratropium bromide monohydrate
Medicine Name Catapres Ampoules Active Ingredients Clonidine hydrochloride
Medicine Name Catapres Tablets 100 micrograms Active Ingredients Clonidine hydrochloride
Medicine Name Giotrif 20 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 30 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 40 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 50 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Glyxambi 10 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Glyxambi 25 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Jardiance 10 mg and 25 mg Film-Coated Tablets Active Ingredients Empagliflozin
Medicine Name Jentadueto 2.5 mg/850 mg film-coated tablets and Jentadueto 2.5 mg/1,000 mg film-coated tablets Active Ingredients Linagliptin, Metformin Hydrochloride
Medicine Name Metalyse 10,000 units Active Ingredients Tenecteplase
Medicine Name Micardis 20 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 40 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 80 mg Tablets Active Ingredients Telmisartan
Medicine Name MicardisPlus 40 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/25 mg Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name Mirapexin prolonged-release tablets Active Ingredients Pramipexole dihydrochloride monohydrate
1 - 0 of 47 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 28 July 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 28 July 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.4: Information added regarding the interference with the 1,5 anhydroglucitol assay used to monitor glycaemic control in patients taking SGLT2 inhibitors.
  • Section 4.4: Update to warning in use with patients who have Diabetic ketoacidosis.
  • Section 4.5: Update to the pharmacokinetic interactions between empaglifozin and inducers of uridine 5'-diphosphoglucuronosyltransferases (UGT).
  • Section 10: Date of revision is updated to 17 July 2020.

Updated on 16 December 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

·         Section 4.8: Minor editorial changes within Table 1

·         Section 5.1: Addition of study data

·         Section 10: Date of revision has been updated to 31 October 2019

Updated on 22 October 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 21 October 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Update to Diabetic Ketoacidosis section to add information on ketone monitoring in surgical patients as per the PRAC recommendation for SGLT2 inhibitors.

Section 10: Date of revision has been updated.

Editorial update in section 4.8: The Irish AE reporting details have also been updated.

Updated on 1 July 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 July 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New SmPC for launch