Last Updated on eMC 07-12-2017 View medicine  | AstraZeneca UK Limited Contact details

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.

Reasons for adding or 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 4.8 - Undesirable effects
  • 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 triangle

Date of revision of text on the SPC:23-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Removal of Black triangle and corresponding text relating to additional monitoring

Section 4.4 – Removal of information under the ‘general’ sub-heading with relation to patients with type 1 diabetes and diabetic Ketoacidosis

Section 4.4 – addition of text related to cases of DKA being fatal. Removal of text related to these cases being reported in clinical trials and post marketing

Section 4.5 –  text removed under ‘other interactions’ with relation to studies not being performed on effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin. Section 4.5 - Editorial changes in section related to ‘Interference with 1.5-AG assay’ subheading

Section 4.8 – editorial changes in ‘increased creatinine’ subsection

Section 9 – addition of ‘Date of first authorisation’ text

Section 10 – updated date of revision

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:12-10-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.2- Minor formatting changes to the subheadings. No change to content

Section 4.5- Minor editorial change to correct grammar.

Section 4.8- summary of safety profile for dapagliflozin plus metformin updated to update pre-specified pooled analysis of 13 placebo controlled studies instead of 12. Description of selected adverse reactions for dapagliflozin plus metformin updated to include statement ‘similar observations were made for the combination of dapagliflozin with metformin in drug naïve patients’

Section 5.1- information and study data on ‘in combination with metformin in drug naïve patients’ added with Minor editorial changes to other sections.

Section 5.2 Minor formatting changes to subheadings. No change to content.

Section 6.1: Minor formatting changes to subheadings. No change to content.

Section 6.5 Minor formatting changes to subheadings. No change to content.

Section 10 Update to revision date.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:20-07-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Update to UK reporting details to match appendix V of the QRD template

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

Date of revision of text on the SPC:20-07-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



 

Section 2 minor formatting changes

Section 3 minor formatting changes

Section 4.4 minor editorial changes and text on ‘combinations not studied’ (GLP-1 analogues) removed.

Section 5.1 minor editorial changes and text on combination therapy with prolonged release exenatide added

Section 10 date of revision updated.

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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:21-04-2017

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 routine preventative foot care added.

Section 4.8 Rash added within ADR Table with a footnote. Other minor editorial amendments made.

Section 6.1 information on film coating updated. section separated for 5mg/850mg and 5mg/1000mg.

Section 10 Date of revision updated.

Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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:19-01-2017

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 4.2 Minor editorial changes

Section 4.5 Information on ‘interference with 1.5-AG assay added.

Section 4.8 Minor editorial changes

Section 5.2 Minor editorial changes and spelling correction

Section 8 Minor editorial changes

Section 10 Date of revision updated.

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:12-12-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.2 inclusion of statement ‘ Adults with normal renal function (GFR  ≥ 90 mL/min) and update to information on renal impairment following article 31 on metformin containing products.

4.3 information on diabeteic ketoacidosis updated to include examples of other acute metabolic acidosis, information on renal impairment updated following article 31 on metformin containing products.

4.4 information on lactic acidosis and renal impairment updated and text on administration of iodinated contrast agents and surgery reworded following article 31 for metformin containing products,

4.5 Repositioning of text, text on alcohol and iodinated contrast agents re-worded. Information on medicinal products which affect renal function/lactic acidosis added following article 31 for metformin containing products.

5.1 Minor editorial changes

5.2 Minor editorial changes

10 revision date

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:28-04-2016

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.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:07-01-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



- Section 6.5 – addition of batch release site & PCTFE packaging
- Section 10 - updated date of revision

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:03-10-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



- Section 7 MAH change
- section 10 updated date of revision

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:24-07-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



- Section 4.8 updated as a result of 30 month safety data (AE table updated and ‘increased creatinine’ paragraph added)

- Section 4.8 updated details for reporting side effects.

- Section 5.1 Blood pressure claims updated.
- Section 10 updated date of revision

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:22-05-2014

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

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • 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:25-04-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.2

Addition of highlighted text in the first paragraph:
When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).

 

Section 4.8

Addition of:

In an add-on to metformin and a sulphonylurea study, up to 24 weeks, 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. No major events of hypoglycaemia were reported.

 

Section 5.1

Addition of ‘sulphonylurea’ under subheading Clinical efficacy and safety

 

Addition of highlighted text in the paragraph under table 2:

Dapagliflozin as an add‑on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin

 

Addition of Table 4. Renamed onle Table 4 to Table 5.

 

Addition of ‘sulphonylurea’ under subheading Fasting plasma glucose.

New values for fasting plasma glucose levels.

 

Addition of ‘sulphonylurea’ under subheading Body weight

 

Section 10

Date of revision

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES