Xigduo 5 mg/850 mg and 5 mg/1,000 mg film coated tablets *
Pharmacy Only: Prescription

Updated on 24 January 2023

File name

63d00bd83b7ba.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 January 2022

File name

20220121 Package Leaflet IE MT Xigduo Film-coated Tablets Wedel Removal CV 22 0004_1643105744.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 04 February 2021

File name

20210129 Package Leaflet IE MT Xigduo Film-coated Tablets Combined BR site update CV 21 0007_1612452829.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 December 2019

File name

20191119-SPC-IE-MT-Xigduo tablets combined-DKA surgical patients-CV 19 0031_1576144268.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)

Updated on 25 October 2019

File name

20191017-SPC-IE-MT-Xigduo tablets combined-Fournier's Gangrene-CV 19 0025_1572007715.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2019

File name

20191017-Package Leaflet-IE-MT Xigduo tablets combined-Fournier's Gangrene-CV 19 0024_1572007379.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 August 2019

File name

20190725-Package Leaflet-IE-MT Xigduo tablets combined-DECLARE-CV 19001_1565353983.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 August 2019

File name

20190725-SPC-IE-MT-Xigduo tablets combined-DECLARE-CV 19 0002_1565354225.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 March 2019

File name

20190304-uk-ie-mt-pl-xigduo-5 mg-850 mg-5 mg-1000mg-Fournier's Gangrene-CV 19 0008_1552495183.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 March 2019

File name

20190304-ue-ie-mt-spc-xigduo-5 mg-850 mg-5 mg-1000 mg-Founier's Gangrene-CV 19 0007_1552495251.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 November 2018

File name

2018-11-12 cPIL Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0090_1543321558.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 6 - date of revision

Updated on 27 November 2018

File name

2018-11-12 cSmPC Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0089_1543322454.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - update to sodium warning

Section 4.2 - posology and administration for patients with renal impairment

Section 4.4 - warnings and precautions for patients with renal impairment

Section 5.1 - clinical trial data added tor fasting plasma glucose, blood pressure and renal impairment

Section 6.6 - clarification of E Number for marcrogol.

Section 10 - date of revision

Updated on 10 October 2018

File name

2018-09-28 cPIL Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0061_1539099622.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 09 October 2018

File name

2018-09-28 cSmPC Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0060_1539099830.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 4.7 - Effects on ability to drive and use machines
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 4.2 – administrative changes and inclusion of confirmation should not be used in patients with GFR<30mL/min.

Section 4.4 – administrative changes

Section 4.7 – administrative changes

Section 9 – Date of last renewal updated to 28th September 2018

Section 10 – Date of revision of the text updated to 28th September 2018

Updated on 07 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 December 2017

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 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
  • Correction of spelling/typing errors
  • Removal of black triangle

Legal category:Product subject to medical prescription which may be renewed (B)

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

Updated on 05 December 2017

File name

PIL_16299_988.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of black triangle

Updated on 19 October 2017

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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.

Updated on 07 September 2017

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.8 Update to UK reporting details to be aligned with Appendix V of QRD template

Updated on 06 September 2017

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 01 August 2017

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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.

Updated on 27 July 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 12 June 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 May 2017

Reasons for 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

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 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 5/1000mg.

Section 10 Date of revision updated.

Updated on 02 May 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 07 February 2017

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 4.5 - 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

Legal category:Product subject to medical prescription which may be renewed (B)

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.

Updated on 03 January 2017

Reasons for 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

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

Updated on 23 December 2016

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 May 2016

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 16 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 29 April 2015

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 29 April 2015

Reasons for updating

  • New PIL for medicines.ie