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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: 09/11/20

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Summary of Product Characteristics last updated on medicines.ie: 9/11/2020
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.

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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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 9 November 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 9 November 2020 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7: Minor update to the address of the Marketing Authorisation Holder (MAH).
  • Section 10: Date of revision has been updated to 28 October 2020.

Updated on 19 October 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: Updated to add information regarding not to use Glyxambi in patients with Type 1 Diabetes, due to clinical trial data showing increased DKA occurrence when treated with empaglifozin.
  • Section 10: Date of revision has been updated.

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 SPC

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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC 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