Glyxambi 25 mg/5 mg film-coated tablets * Pharmacy Only: Prescription
Company:
Boehringer Ingelheim LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 02 March 2023
File name
6400ddf72b501.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 April 2022
File name
Annex PIL text Rottendorf_1651142927.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 28 April 2022
File name
G5-EU-SPC-11 - medicines.ie_1651134434.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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 4.5: Update to section 4.5 Interactions to add a statement regarding lithium
- Section 4.8: Update to section 4.8 to add the AE tubulointerstitial nephritis (frequency very rare)
- Section 10: Date of revision of the SmPC has also been updated
Updated on 12 April 2022
File name
Annex PIL text Rottendorf_1649766825.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 April 2022
File name
G5-EU-SPC-10-med.ie_1649670747.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Update section 4.8 of the SmPC to include the side effect ‘constipation’. ADR constipation added with a frequency ‘common’.
In addition, during the assessment process the following additional updates have been made:
Necrotising fasciitis of the perineum (Fournier´s gangrene) frequency changed from ‘not known’ to ‘rare’
Volume depletion – addition of a footnote to indicate that studies with empagliflozin in patients with heart failure (where half of the patients had type 2 diabetes mellitus) showed a higher frequency of volume depletion
Section 10 Date of revision of the SmPC has been updated
Updated on 21 February 2022
File name
G5-EU-SPC-9-med.ie_1645459773.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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
The following sections of the SmPC have been updated:
- Section 4.2: Update to section on renal impairment; inclusion of a table on dose adjustment recommendations.
- Section 4.4: Update to section on Renal impairment and lowered eGFR threshold value; editorial updates to section on Monitoring of renal function; Inclusion of a section on chronic kidney disease.
- Section 5.1: Update to the section on Cardiovascular safety to include information about the effect of empagliflozin on primary combined endpoint of CV death, non-fatal MI and non-fatal stroke.
- Section 10: Date of revision of the SmPC has also been updated
Editorial updates to sections 4.8 and 5.1.
Updated on 09 September 2021
File name
Annex PIL text Rottendorf_1631207029.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 09 September 2021
File name
G5-EU-SPC-8-med.ie_1631183123.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The main changes relate to the following sections of the SmPC:
- Removal of Black triangle
- Section 4.2: rewording of the statement when Glyxambi is used in combination with metformin; inclusion of a new section ‘Missed doses’ with existing text; editorial changes.
- Section 4.4: sub-heading revised; text reordered; editorial changes
- Section 4.6: deletion of the first paragraph; editorial changes
- Section 4.8: update to introductory statement on adverse reactions; updated AE reporting information; editorial changes
- Section 9: inclusion of ‘date of latest renewal’ statement and date
- Section 10: update to date of revision of the text
Editorial updates to sections 2, 3, 4.5, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1, and 8.
Updated on 09 November 2020
File name
Annex PIL text Rottendorf_1604932766.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 November 2020
File name
G5-ALL-SPC-7-med.ie_1604931388.pdf
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
File name
G5-ALL-SPC-6-med.ie_1603101427.pdf
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
File name
Annex PIL text_1595939290.pdf
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
File name
G5-ALL-SPC-5-medicines.ie_1595938355.pdf
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
File name
G5-ALL-SPC-4-medicines.ie_1576500117.pdf
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
File name
Annex PIL text - Update to Irish AE reporting_1571760541.pdf
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
File name
G5-ALL-SPC-3-Approved_1571663273.pdf
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 01 July 2019
File name
Cropped-PIL 317115-01 07.02.2019 PIP047151-001 AMT 91879-IA safety change_1561973790.pdf
Reasons for updating
- New PIL for new product
Updated on 01 July 2019
File name
G5-ALL-SPC-2_1561973461.pdf
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