Forxiga 5 mg, 10 mg Film coated tablets *
Pharmacy Only: Prescription

Updated on 22 July 2022

File name

62dac42eac950.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

Updated on 22 July 2022

File name

62dac2debd1d0.pdf

Reasons for updating

  • 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 31 March 2022

File name

20220325 Package Leaflet IE MT Forxiga Film-coated Tablets 5mg 10mg Wedel Removal CV 22 0011_1648747862.pdf

Reasons for updating

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

Updated on 22 November 2021

File name

20211115 Package Leaflet Forxiga Film-coated Tablets 5mg 10mg Paediatric Indication CV 21 0054_1637576019.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_1637575899.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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_1635419546.pdf

Reasons for updating

  • 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 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_1635419298.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • 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 10mg DAPA CKD CV 21 0024_1628693304.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 - how to report a side effect
  • 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 10mg DAPA CKD CV 21 0026_1628693127.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 6 - date of revision

Updated on 12 April 2021

File name

20210406 Package Leaflet IE MT Forxiga Film-coated Tablets 10mg Blister Change CV 21 0017_1618238622.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Green = added text

Red = deleted text

...

What Forxiga looks like and contents of the pack

...

Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 10 film-coated tablets in
non-perforated blisters,
14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 10x1,
30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

...

Date of Revision updated to 04/2021

 

Updated on 12 April 2021

File name

20210406 SPC IE MT Forxiga Film-coated Tablets 10mg Blister Change CV 21 0016_1618236819.pdf

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Green = added text

Red = deleted text

...

6.5       Nature and contents of container

Pack size of 10 film-coated tablets in non-perforated blisters.

Pack sizes of 14, 28 and 98 film‑coated tablets in non‑perforated calendar blisters.

Pack sizes of 10x1, 30x1 and 90x1 film‑coated tablets in perforated unit dose blisters.

...

8.         MARKETING AUTHORISATION NUMBER(S)

...

EU/1/12/795/011 10 x 1 (unit dose) film-coated tablets

...

10.       DATE OF REVISION OF THE TEXT

6th April 2021

 

Updated on 04 February 2021

File name

20210129 Package Leaflet IE MT Forxiga Film-coated Tablets 10mg BR site update CV 21 0006_1612452723.pdf

Reasons for updating

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

Updated on 21 January 2021

File name

20201111-SmPC-IE-MT-Forxiga Tablets 10mg-New Pack Size-CV 20 0038_1611259156.pdf

Reasons for updating

  • Other

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

Updated on 20 November 2020

File name

20201111-SmPC-IE-MT-Forxiga Tablets 10mg-New Pack Size-CV 20 0038_1605862181.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

 

6.5       Nature and contents of container

Alu/Alu blister

Pack size of 10 film-coated tablets in non-perforated blisters.

Pack sizes of 14, 28 and 98 film‑coated tablets in non‑perforated calendar blisters.

Pack sizes of 30x1 and 90x1 film‑coated tablets in perforated unit dose blisters.

[..]

  1.          MARKETING AUTHORISATION NUMBER(S)

[..]

EU/1/12/795/011 10 film-coated tablets

[..]

Updated on 20 November 2020

File name

20201111-Package Leaflet-IE-MT-Forxiga Tablets 10mg-New-Pack-Size-CV 20 0039_1605861931.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

What Forxiga looks like and contents of the pack

[..]

Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 10 film-coated tablets in non-perforated blisters, 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

Updated on 06 November 2020

File name

20201103-SmPC-IE-MT-Forxiga Tablets 10mg-DAPA HF-CV 20 0035_1604667687.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 10mg-DAPA HF-CV 20 0037_1604667555.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 10 mg-DKA surgical patients-CV 19 0030_1576142164.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 10 mg-Fournier's Gangrene-CV 19 0021_1571998509.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 10 mg-Fournier's Gangrene-CV 19 0023_1571998295.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 10 mg-DECLARE-CV 19 0006_1565349268.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 10 mg-DECLARE-CV 19 0004_1565349554.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 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-10mg-Tablets-Angioedema-CV19 0075_1560960868.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-10mg-angioedema-CV 19 0069_1560961670.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 19 June 2019

File name

20190529-uim-spc-forxiga-10mg-angioedema-CV 19 0069_1560960897.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-10mg-Tablets-Type 1-CV CV 19 0057_1554307581.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 April 2019

File name

20190320-uim-spc-forxiga-10mg-Type 1-CV 19 0040_1554307753.pdf

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Updated on 03 April 2019

File name

20190320-uim-spc-forxiga-10mg-Type 1-CV 19 0040_1554307700.pdf

Reasons for updating

  • New SPC for new product

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