Forxiga 10 mg Film coated tablets *
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 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- Individual PILs superseded by joint PIL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 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 10x1,
non-perforated blisters,
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.
[..]
- 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)