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AstraZeneca Pharmaceuticals (Ireland) DAC

Block B, Liffey Valley Office Campus, Dublin 22, Ireland
Telephone: +353 1 609 7100
Fax: +353 1 686 5038
Medical Information Direct Line: 1800 800 899 Freephone
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +353(0)1 609 7100 Supply & non-medical enquiries
Medical Information Facsimile: +44 (0)1582 838 003
Summary of Product Characteristics last updated on medicines.ie: 20/10/2017
SPC Forxiga 5 mg & 10 mg film coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • 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 9 - Date of first authorisation/renewal of the authorisation
Date of revision of text on the SPC:   12-Oct-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.4 Minor editorial update. No change to content.

Section 4.5 Minor editorial update. No change to content.

Section 4.8 Minor editorial update. No change to content.

Section 5.1 information and results from study on ‘in combination with metformin in drug naïve patients’ added and minor editorial update

Section 9 minor editorial update. No change to content

Section 10 update to revision date

Updated on 12/09/2017 and displayed until 20/10/2017
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 4.8 – Undesirable effects - how to report a side effect
  • 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:   28-Aug-2017
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 correponding 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. Other information with relation to type 1 diabetes and diabetic ketoacidosis still remains further down within this section and minor editorial change.

Section 4.5 text 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 removed and minor editorial changes.

Section 4.8 minor editorial update and update to UK reporting details.

Section 9- date of first authorisation and date of latest renewal subheading added and date of renewal added.

Section 10- date of latest renewal added.

Updated on 27/07/2017 and displayed until 12/09/2017
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 4.8 - 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:   20-Jul-2017
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 change

Section 3- Minor formatting change

Section 4.4 editorial change to renal impairment and Hepatic impairment subheading and update to Diabetic ketoacidosis text to include fatal cases also. Removal of text stating no studies with GLP-1 analogues.

Section 4.8 – minor formatting change to footnote section under table 1

Section 5.1- ‘Clinical efficacy and safety’ section updated with updated figures.  Information on combination thereapy with prolonged release exenatide added. Minor editorial changes.

Section 10- update to revision date.

Updated on 02/05/2017 and displayed until 27/07/2017
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 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:   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 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 06/02/2017 and displayed until 02/05/2017
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
  • 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:   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 4.4- 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 26/05/2016 and displayed until 06/02/2017
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:   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 16/10/2014 and displayed until 26/05/2016
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:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



- Section 7 MAH change

 

- Section 10 change to revision date  

Updated on 13/08/2014 and displayed until 16/10/2014
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:   Product subject to medical prescription which may be renewed (B)

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

Updated on 29/05/2014 and displayed until 13/08/2014
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:   Product subject to medical prescription which may be renewed (B)

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 14/02/2014 and displayed until 29/05/2014
Reasons for adding or updating:
  • New SPC for new product
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Dapagliflozin propanediol monohydrate