Forxiga 5 mg film coated tablets *
Pharmacy Only: Prescription

When a pharmaceutical company changes any document, 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 22 November 2021

File name

20211115 Package Leaflet Forxiga Film-coated Tablets 5mg 10mg Paediatric Indication CV 21 0054_1637575583.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 1. What Forxiga is and what it is used for revised: 

What Forxiga is used for
Forxiga is used in adult patients (aged 18 years and older) to treat:


• Type 2 diabetes
- in adults and children aged 10 years and older.
- if your type 2 diabetes cannot be controlled with diet and exercise.
- Forxiga can be used on its own or together with other medicines to treat diabetes.
- It is important to continue to follow the advice on diet and exercise given to you by your
doctor, pharmacist or nurse.
• Heart failure
- in patientsadults (aged 18 years and older) with symptoms due to a weak pump function
of the heart.
• Chronic kidney disease
- in patientsadults with reduced kidney function.

Section 2. What you need to know before you take Forxiga - section Children and adolescents revised:

Children and adolescents
Forxiga can be used in children aged 10 years and older for the treatment of type 2 diabetes. No data are available in children below 10 years of age.


Forxiga is not recommended for children and adolescents under 18 years of age for the treatment of heart failure or for the treatment of chronic kidney disease, because it has not been studied in these
patients.

Section 6. Contents of the pack and other information - revision date updated to 11/2021

Updated on 22 November 2021

File name

20211115 SPC IE MT Forxiga Film-coated Tablets 5mg 10 mg Paediatric Indication 21 0053_1637575042.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.1 Therapeutic indications - therapeutic indication for Type 2 diabetes mellitus extended to children aged 10 years and above:

Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance.
- in addition to other medicinal products for the treatment of type 2 diabetes.

Section 4.2 Posology and method of administration - section Paediatric population revised: 

No dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and above (see sections 5.1 and 5.2). No data are available for children below 10 years of age.
The safety and efficacy of dapagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children aged 0 to < 18 years have not yet been established. No data are
available.

Section 4.8 Undesirable effects - addition of dapagliflozin safety profile for Paediatric population:

Paediatric population
The dapagliflozin safety profile observed in a clinical study in children aged 10 years and above with type 2 diabetes mellitus (see section 5.1) was similar to that observed in the studies in adults.

Section 5.1 Pharmacodynamic properties - section Paediatric population revised:

Paediatric population

Type 2 diabetes mellitus
In a clinical study in children and adolescents aged 10-24 years with type 2 diabetes mellitus, 39 patients were randomised to dapagliflozin 10 mg and 33 to placebo, as add-on to metformin, insulin
or a combination of metformin and insulin. At randomisation, 74% of the patients were < 18 years of age. The adjusted mean change in HbA1c for dapagliflozin relative to placebo from baseline to
week 24 was -0.75% (95% CI -1.65, 0.15). In the age group < 18 years the adjusted mean change in HbA1c for dapagliflozin relative to placebo was -0.59% (95% CI -1.66, 0.48). In the age group
≥ 18 years, the mean change from baseline in HbA1c was -1.52% in the dapagliflozin treated group (n=9) and 0.17% in the placebo treated group (n=6). Efficacy and safety were similar to that observed
in the adult population treated with dapagliflozin. Safety and tolerability were further confirmed in a 28-week safety extension of the study.
The European Medicines Agency has deferred the obligation to
submit the results of studies with dapagliflozin in one or more subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).

Heart failure and chronic kidney disease
The European Medicines Agency has waived the obligation to submit the results of studies with dapagliflozin in all subsets of the paediatric population in the prevention of cardiovascular events in
patients with chronic heart failure and in the treatment of chronic kidney disease (see section 4.2 for information on paediatric use).

Section 5.2 Parmacokinetic properties - section Paediatric population revised: 

Paediatric population

Pharmacokinetics and pharmacodynamics (glucosuria) in children with type 2 diabetes mellitus aged 10-17 years were similar to those observed in adults with type 2 diabetes mellitus.in the paediatric
population have not been studied.

Section 10. Date of revision of the text - revision date updated to 15 November 2021.

 

Updated on 28 October 2021

File name

20211025 SPC IE MT Forxiga Film-coated Tablets 5mg 10 mg Removal of T1DM CV 21 0039_1635418149.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 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC

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

Updated on 28 October 2021

File name

20211025 Package Leaflet IE MT Forxiga Film-coated Tablets 5mg 10 mg Removal of T1DM CV 21 0040_1635417760.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Individual PILs superseded by joint PIL

Updated on 11 August 2021

File name

20210805 SPC IE MT Forxiga Film-coated Tablets 5mg DAPA CKD CV 21 0023_1628692695.pdf

Reasons for 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 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

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

Updated on 11 August 2021

File name

20210805 Package Leaflet IE MT Forxiga Film-coated Tablets 5mg DAPA CKD CV 21 0025_1628692247.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 3 - how to take/use

Updated on 04 February 2021

File name

20210129 Package Leaflet IE MT Forxiga Film-coated Tablets 5mg BR site update CV 21 0005_1612452634.pdf

Reasons for updating

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

Updated on 06 November 2020

File name

20201103-SmPC-IE-MT-Forxiga Tablets 5mg-DAPA HF-CV 20 0034_1604667094.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 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)

Updated on 06 November 2020

File name

20201103-Package Leaflet-IE-MT-Forxiga Tablets 5 mg-DAPA HF-CV 20 0036_1604666878.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 December 2019

File name

20191119-SmPC-IE-MT-Forxiga Tablets 5 mg-DKA surgical patients-CV 19 0029_1576141955.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-SmPC-IE-MT-Forxiga Tablets 5 mg-Fournier's Gangrene-CV 19 0020_1571997763.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-Forxiga Tablets 5 mg-Fournier's Gangrene-CV 19 0022_1571997546.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 09 August 2019

File name

20190731-Package Leaflet-IE-MT-Forxiga Tablets 5 mg-DECLARE-CV 19 0005_1565348040.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

20190731-SPC-IE-MT-Forxiga Tablets 5 mg-DECLARE-CV 19 0003_1565348613.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

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

Updated on 20 June 2019

File name

20190529-ie-mt-package-leaflet-Forxiga-5mg-Tablets-Angioedema-CV 19 0074_1560960807.pdf

Reasons for updating

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

Updated on 19 June 2019

File name

20190529-uim-spc-forxiga-5mg-angioedema-CV 19 0068_1560943748.pdf

Reasons for updating

  • 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 04 April 2019

File name

20190320-ie-mt-package-leaflet-Forxiga-5mg-Tablets-Type 1-CV 19 0056_1554307310.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 April 2019

File name

20190320-uk-spc-forxiga-5mg-type 1-UIM CV 19 0039_1554307452.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - 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 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Updated on 13 March 2019

File name

20190304-uk-ie-mt-pl-Forxiga-5-10 mg-Fournier's-Gangrene-CV190005_1552490149.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-uk-ie-mt-spc-Forxiga-5-10 mg-Fourner's-Gangrene-CV190004_1552490213.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 26 November 2018

File name

2018-11-12 cSmPC Forxiga 5 mg & 10 mg Tablets UIM CV 18 0099_1543235014.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 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

Changes to Sections:

4.2: renal dosing

4.4: for patients with renal impairment

5.1: additional data for patients with renal impairment and high blood pressure

10: date of revision

Updated on 20 October 2017

Reasons for 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

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 20 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 12 September 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 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

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 08 September 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of black triangle
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 08 September 2017

File name

PIL_15964_350.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 July 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 4.8 - Undesirable effects
  • 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 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 26 July 2017

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 3 - how to take/use
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 02 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 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 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 26 April 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 06 February 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 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

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 01 February 2017

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 26 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 08 January 2015

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 16 October 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 MAH change

 

- Section 10 change to revision date  

Updated on 14 October 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 August 2014

Reasons for 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

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 07 August 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 29 May 2014

Reasons for updating

  • 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 5.1 Pharmacodynamic properties – incorporation of 4 year long term efficacy data

- Section 10 – revision date

Updated on 27 March 2014

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 February 2014

Reasons for updating

  • New SPC for new product
  • 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