Last Updated on eMC 12-07-2018 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 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)

Date of revision of text on the SPC:28-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections 2 & 3  -  admin/editorial changes

Section 4.2 – saxagliptin dosing for patients with GFR<30 is no longer contraindicated, now max daily dose of 2.5mg.

Section 4.4 – Moderate renal impairment now defined as GFR>30 to <45mL/min.

Section 4.8 – MHRA AE reporting updated

Section 5.2 – Study results for renal impairment patients updated

Sections 6.1 & 8 – admin/editorial changes

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:26-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1- indication re-written to incorporate updated information in section 5.1

Section 4.2  information on ‘For patients inadequately controlled on dual combination therapy of dapagliflozin and metformin, or for patients switching from triple combination therapy of saxagliptin, metformin and dapagliflozin taken as separate tablets’ added and editorial changes.

Section 4.3- editorial changes

Section 4.5 minor editorial changes

Section 4.8 minor editorial changes

Section 5.1 information on ‘ saxagliptin add on to dapagliflozin plus metformin therapy’ added and ‘saxagliptin and dapagliflozin add on to metformin therapy’ added.

Section 5.2 editorial changes

Section 5.3 editorial changes

Section 10 date of revision updated

Reasons for adding or updating:

  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 6.5 - Nature and contents of container
  • 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:12-12-2016

Legal Category:POM

Black Triangle (CHM): NO

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 and minor editorial changes.

4.6 Minor editorial changes

4.8 minor editorial changes

5.1 Minor editorial changes

5.2 Minor editorial changes

5.3 Minor editorial changes

6.5 minor editorial changes

7 minor editorial changes

10 revision date

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: Minor editorial amendments following renewal

Section 4.1: Minor editorial amendments  following renewal

Section 4.2 Minor editorial amendements following renewal. ‘Komboglyze’ changed to ‘medicinal product’ throughout the section and information on adolescents added to paediatric population

Section 4.3: Minor editorial amendments following renewal

Section 4.4: Removal of information on substitute for insulin, minor editorial amendments following renewal, Komboglyze changed to medicinal product throughout section.

Section 4.5 minor editorial amendments following renewal.

Section 4.6 minor editorial following renewal, Komboglyze changed to medicinal product throughout this section.

Section 4.7 Minor editorial following renewal

Section 4.8 Minor editorial following renewal

Section 5.1 Minor editorial following renewal

Section 5.2 Minor editorial following renewal

Section 5.3: minor editorial following renewal

Section 6.3 minor editorial-change from 36 months to 3 years

Section 6.6 removal of no special requirements

Section 9; minor editorial following renewal

Section 10: date of revision updated

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:28-04-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 Savor all cause mortality data included.

Section 10 Revision date 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 10 - Date of revision of the text

Date of revision of text on the SPC:01-10-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 –updated text on cardiac failure warnings.

Section 4.4 – addition of arthalgia warning.

Section 4.8 – addition of footnote referring to section 4.4 for arthalgia side effect.

Section 10 – date of revision updated.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-08-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 addition of constipation as an adverse drug reaction.

Section 10 revision date updated.

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:20-05-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Malta AE reporting wording updated (no change to 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:15-10-2014

Legal Category:POM

Black Triangle (CHM): NO

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 4.2 - 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 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): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.2: Elderly populations wording updated in line with SAVOR study.

- Section 4.4: Elderly populations wording updated in line with SAVOR study.

- Section 4.8: Text updated in line with SAVOR study

- Section 4.8: AE reporting wording updated.

- Section 5.1: updated in line with SAVOR study.
- Section 10: updated date of revision

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-06-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.4 Acute Pancreatitis text added
- Section 10 Updated date of revision


Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.1 – addition of Triple Oral Therapy indication

- Section 4.2 – posology included for patients inadequately controlled on dual combination therapy of a sulphonylurea and metformin, or for patients switching from triple combination therapy of saxagliptin, metformin and a sulphonylurea taken as separate tablets.

- Section 4.3 – cross reference to section 6.1 included

- Section 4.4 – sulphonylurea added to sub-section regarding use with medicinal products known to cause hypoglycaemia

- Section 4.6 – typographical change

- Section 4.7 – advice included to warn patients of the risk of hypoglycaemia when used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas)

- Section 4.8 – information provided in description of selected adverse reactions when used as an add-on to metformin plus a sulphonylurea; additional information regarding hypoglycaemia

- Section 5.1 additional information regarding Onglyza add-on combination therapy with metformin and sulphonylurea; Additional study data included in Table 4

- Section 6.6 – addition of standard statement regarding disposal of unused product or waste material

- Section 10 – updated date of revision

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-01-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3
Shelf-life extended from 30 to 36months

Section 10
Revision date updated to reflect Section 6.3 change.

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): NO