Forxiga 5 mg film coated tablets
- Name:
Forxiga 5 mg film coated tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/10/19
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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 2 March 2020 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Section 5 'Minimising the Risk of DKA' (new text in green): 'In patients who are hospitalised for major surgical procedures or acute serious medical illness. Monitoring of ketones is recommended in these patients. Measurement of blood ketones is preferred to urine. Treatment with Forxiga may be restarted once the ketone values are normal and the patient’s condition has stabilised.'
Updated on 2 March 2020 Ed-Ptnt
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Section 'Information for Doctors, Pharmacists and Nurses' (new text in green): 'Stop Forxiga treatment temporarily before surgical procedures or hospitalisation for serious acute illness. Monitoring of ketones (blood in preference to urine) is recommended.'
Updated on 2 March 2020 Ed-Ptnt
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Minor amendments
Updated on 12 December 2019 SmPC
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 SmPC
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 PIL
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 9 August 2019 PIL
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 9 August 2019 SmPC
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 17 July 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 17 July 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 17 July 2019 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 20 June 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 June 2019 SmPC
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 4 April 2019 PIL
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 3 April 2019 SmPC
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 PIL
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 SmPC
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 SmPC
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 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 12 September 2017 SmPC
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 8 September 2017 PIL
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 8 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 27 July 2017 SmPC
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 PIL
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 2 May 2017 SmPC
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 PIL
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 6 February 2017 SmPC
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 1 February 2017 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 26 May 2016 SmPC
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 PIL
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 8 January 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 16 October 2014 SmPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 13 August 2014 SmPC
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 7 August 2014 PIL
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 SmPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 14 February 2014 SmPC
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
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