Forxiga 5 mg & 10 mg film coated tablets
Last Updated on eMC 02-May-2017 View document | AstraZeneca UK Limited Contact details
Versions
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 02-May-2017 and displayed until Current
Reasons for adding or updating:
- 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
Date of revision of text on the SPC: 21-Apr-2017
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.4- information on lower limb amputations added. Advice to counsel patients on routin preventative foot care added.
Section 4.8 Rash added within ADR Table with a footnote. Other minor editorial amendments made.
Section 5.1 ATC code updated
Section 10 revision date updated
Updated on 06-Feb-2017 and displayed until 02-May-2017
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 19-Jan-2017
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 2- Minor editorial changes
Section 3- Minor editorial changes
Section 4.4- Elderly subheading updated
Section 4.5-Information on interference with 1,5 AG assay added.
Section 4.8-Minor editorial changes and update to elderly subheading
Section 5.1-Minor editorial changes including correction of spelling
Section 5.2 Minor editorial changes and update to elderly subheading
Section 6.1 Update to Crospovidone
Section 8 Minor editorial updates
Section 10 update to revision date
Updated on 26-May-2016 and displayed until 06-Feb-2017
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 28-Apr-2016
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.4 – Diabetic ketoacidosis wording added.
Section 4.8 – Diabetic ketoacidosis AE added.
Section 4.8 – MT AE reporting address updated.
Section 10 – Date of revision updated.
Updated on 15-Oct-2014 and displayed until 26-May-2016
Reasons for adding or updating:
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 03-Oct-2014
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
- Section 7 MAH change
- Section 10 revision date
Updated on 08-Aug-2014 and displayed until 15-Oct-2014
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 24-Jul-2014
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
$0- Section 4.8 updated as a result of 30 month safety data (AE table updated and ‘increased creatinine’ paragraph added)$0$0- Section 4.8 updated details for reporting side effects. $0$0- Section 5.1 Blood pressure claims updated$0- Section 10 Updated date of revision$0Updated on 28-May-2014 and displayed until 08-Aug-2014
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 22-May-2014
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
- Section 5.1 Pharmacodynamic properties – incorporation of 4 year long term efficacy data
- Section 10 – revision date
Updated on 02-Jan-2014 and displayed until 28-May-2014
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 18-Dec-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 1. - Removed black triangle symbol
- Section 4.8 - Addition of this statement:
In an add-on to metformin and a sulphonylurea study, up to 24 weeks, no episodes of major hypoglycaemia were reported. Minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.
- Section 4.8. - Addition of IMB details for AE reporting
- Section 5.1 –
Changes to table 4, column for sulphonylurea (glimepiride) removed. Addition of table 5 Old table 5 is now table 6 Addition of metformin and sulphonylurea Changes to some % values
Section 10 - updated date of revision
Updated on 07-Nov-2013 and displayed until 02-Jan-2014
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Date of revision of text on the SPC: 15-Oct-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Additional monitoring text at the top.
Section 4.8 - Addition of adverse event reporting details
Section 10 - Amendment to revision date
Updated on 07-May-2013 and displayed until 07-Nov-2013
Reasons for adding or updating:
- 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
Date of revision of text on the SPC: 25-Apr-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
- Section 4.4 – removal of reference to DPP4 from combinations not studied sub-section
- Section 4.8 – included types of studies for which the second paragraph in the hypoglycaemia sub-section referred to
- Section 5.1 – updated study data to include information relation to treat as add-on to sitagliptin (with or without metformin)
- section 10 – revision date updated to reflect approval of above changes
Updated on 27-Mar-2013 and displayed until 07-May-2013
Reasons for adding or 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
Date of revision of text on the SPC: 21-Mar-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
- Section 4.8 – updated with new long term data and correction post-MAA
- Section 5.1 – updated with new long term data and corrections post-MAA
- section 10 – revision date updated to reflect approval of above changes
Updated on 16-Nov-2012 and displayed until 27-Mar-2013
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): YES
AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
+44 (0)1582 838 000
+44 (0)1582 838 003
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 837 837
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