Glyxambi 25 mg/5 mg film-coated tablets
- Name:
Glyxambi 25 mg/5 mg film-coated tablets
- Company:
Boehringer Ingelheim Limited
- Active Ingredients:
- 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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Boehringer Ingelheim Limited
Company Products
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
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
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
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
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
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
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
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
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
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
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
Reasons for updating
- New SmPC for new product
Free text change information supplied by the pharmaceutical company
New SmPC for launch