Xigduo 5 mg/850 mg and 5 mg/1,000 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
Updated on 05 December 2024
File name
20241128 SPC IE MT Xigduo Film-Coated Tablets PRAC Polycaethemia CV 24 0024.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)
Free text change information supplied by the pharmaceutical company
Update to section 4.4 to include the warning
Increased haematocrit
Increased haematocrit has been observed with dapagliflozin treatment (see section 4.8). Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.
Updated on 29 July 2024
File name
20240718 SPC IE MT Xigduo Film-Coated Tablets Resubmission of Forxiga Harmonisation CV 24 0013.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 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
Excipient(s) with known effect:
Xigduo contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.
Section 4.4
Sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, i.e. is essentially “sodium free”.
4.5 Interaction with other medicinal products and other forms of interaction
[...]
Effect of dapagliflozin on other medicinal products
[...]
Dapagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after dapagliflozin initiation. Please refer the patient to the lithium prescribing doctor in order to monitor serum concentration of lithium.
4.8 Undesirable effects
[...]
Table 2. Adverse reactions – Renal and urinary disorders – Very rare
Tubulointerstitial nephritis
5.1 Pharmacodynamic properties
Mechanism of action - dapagliflozin
[...]
This combined with osmotic diuresis leads to a reduction in volume overload, reduced blood pressure, and lower preload and afterload, which may have beneficial effects on cardiac remodelling and diastolic function, and preserve renal function. Other effects include an increase in haematocrit and reduction in body weight. The cardiac and renal benefits of dapagliflozin are not solely dependent on the blood glucose-lowering effect. Other effects include an increase in haematocrit and reduction in body weight.
Updated on 29 July 2024
File name
20240718 Package Leaflet IE MT Xigduo Film-Coated Tablets Resubmission of Forxiga Harmonisation CV 24 0014.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
Free text change information supplied by the pharmaceutical company
2. What you need to know before you take Xigduo/Ebymect/Qtern
Other medicines and Xigduo
…..
- if you are taking lithium because Xigduo/Ebymect/Qtern can lower the amount of lithium in your blood.
4. Possible side effects
Very rare
- inflammation of the kidneys (tubulointerstitial nephritis)
Other minor administrative changes throughout
Updated on 16 February 2024
File name
20240208 SPC IE MT Xigduo Film-Coated Tablets Update Vit B12 Deficiency CV 24 0003.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 16 February 2024
File name
20240208 Package Leaflet IE MT Xigduo Film-Coated Tablets Update Vit B12 Deficiency CV 24 0004.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 January 2024
File name
20240119 SPC IE MT Xigduo Film-coated Tablets PRAC Phimosis CV 24 0002.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 24 May 2023
File name
20230519 Package Leaflet IE MT Xigduo Film-coated Tablets Postcode update CV 23 0020.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
6. Contents of the pack and other information
[...]
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-151 85152 57 Södertälje
Sweden
[...]
This leaflet was last revised in 0205/2023.
Updated on 13 February 2023
File name
20230203 SPC IE MT Xigduo Film-coated Tablets Forxiga Harmonisation CV 23 0005.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 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)
Updated on 13 February 2023
File name
20230203 Package Leaflet IE MT Xigduo Film-coated Tablets Forxiga Harmonisation CV 23 0004.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 24 January 2023
File name
20191119-SPC-IE-MT-Xigduo tablets combined-DKA surgical patients-CV 19 0031.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 January 2022
File name
20220121 Package Leaflet IE MT Xigduo Film-coated Tablets Wedel Removal CV 22 0004.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 February 2021
File name
20210129 Package Leaflet IE MT Xigduo Film-coated Tablets Combined BR site update CV 21 0007.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 December 2019
File name
20191119-SPC-IE-MT-Xigduo tablets combined-DKA surgical patients-CV 19 0031.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-SPC-IE-MT-Xigduo tablets combined-Fournier's Gangrene-CV 19 0025.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 Xigduo tablets combined-Fournier's Gangrene-CV 19 0024.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 August 2019
File name
20190725-Package Leaflet-IE-MT Xigduo tablets combined-DECLARE-CV 19001.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
20190725-SPC-IE-MT-Xigduo tablets combined-DECLARE-CV 19 0002.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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 March 2019
File name
20190304-uk-ie-mt-pl-xigduo-5 mg-850 mg-5 mg-1000mg-Fournier's Gangrene-CV 19 0008.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-ue-ie-mt-spc-xigduo-5 mg-850 mg-5 mg-1000 mg-Founier's Gangrene-CV 19 0007.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 27 November 2018
File name
2018-11-12 cPIL Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0090.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 6 - date of revision
Updated on 27 November 2018
File name
2018-11-12 cSmPC Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0089.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.6 - Special precautions for disposal and other handling
- 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 - update to sodium warning
Section 4.2 - posology and administration for patients with renal impairment
Section 4.4 - warnings and precautions for patients with renal impairment
Section 5.1 - clinical trial data added tor fasting plasma glucose, blood pressure and renal impairment
Section 6.6 - clarification of E Number for marcrogol.
Section 10 - date of revision
Updated on 10 October 2018
File name
2018-09-28 cPIL Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0061.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 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 09 October 2018
File name
2018-09-28 cSmPC Xigduo 5 mg-850 mg & 5 mg-1000 mg UIM CV 18 0060.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 4.7 - Effects on ability to drive and use machines
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 4.2 – administrative changes and inclusion of confirmation should not be used in patients with GFR<30mL/min.
Section 4.4 – administrative changes
Section 4.7 – administrative changes
Section 9 – Date of last renewal updated to 28th September 2018
Section 10 – Date of revision of the text updated to 28th September 2018
Updated on 07 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- 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 corresponding 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
Section 4.4 – addition of text related to cases of DKA being fatal. Removal of text related to these cases being reported in clinical trials and post marketing
Section 4.5 – text removed 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. Section 4.5 - Editorial changes in section related to ‘Interference with 1.5-AG assay’ subheading
Section 4.8 – editorial changes in ‘increased creatinine’ subsection
Section 9 – addition of ‘Date of first authorisation’ text
Section 10 – updated date of revision
Updated on 05 December 2017
File name
PIL_16299_988.pdf
Reasons for updating
- New PIL for new product
Updated on 05 December 2017
Reasons for updating
- 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 4 - possible side effects
- Change to section 6 - date of revision
- Removal of black triangle
Updated on 19 October 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 6.5 - Nature and contents of container
- 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 4.2- Minor formatting changes to the subheadings. No change to content
Section 4.5- Minor editorial change to correct grammar.
Section 4.8- summary of safety profile for dapagliflozin plus metformin updated to update pre-specified pooled analysis of 13 placebo controlled studies instead of 12. Description of selected adverse reactions for dapagliflozin plus metformin updated to include statement ‘similar observations were made for the combination of dapagliflozin with metformin in drug naïve patients’
Section 5.1- information and study data on ‘in combination with metformin in drug naïve patients’ added with Minor editorial changes to other sections.
Section 5.2 Minor formatting changes to subheadings. No change to content.
Section 6.1: Minor formatting changes to subheadings. No change to content.
Section 6.5 Minor formatting changes to subheadings. No change to content.
Section 10 Update to revision date.
Updated on 07 September 2017
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 September 2017
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 01 August 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 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 changes
Section 3 minor formatting changes
Section 4.4 minor editorial changes and text on ‘combinations not studied’ (GLP-1 analogues) removed.
Section 5.1 minor editorial changes and text on combination therapy with prolonged release exenatide added
Section 10 date of revision updated.
Updated on 27 July 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 12 June 2017
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 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 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)
Free text change information supplied by the pharmaceutical company
Section 4.4- information on lower limb amputations added. Advice to counsel patients on routine preventative foot care added.
Section 4.8 Rash added within ADR Table with a footnote. Other minor editorial amendments made.
Section 6.1 information on film coating updated. section separated for 5mg/850mg and 5/1000mg.
Section 10 Date of revision updated.
Updated on 02 May 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 07 February 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 5.2 - Pharmacokinetic properties
- 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 4.2 Minor editorial changes
Section 4.5 Information on ‘interference with 1.5-AG assay added.
Section 4.8 Minor editorial changes
Section 5.2 Minor editorial changes and spelling correction
Section 8 Minor editorial changes
Section 10 Date of revision updated.
Updated on 03 January 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 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
4.2 inclusion of statement ‘ Adults with normal renal function (GFR ≥ 90 mL/min) and update to information on renal impairment following article 31 on metformin containing products.
4.3 information on diabeteic ketoacidosis updated to include examples of other acute metabolic acidosis, information on renal impairment updated following article 31 on metformin containing products.
4.4 information on lactic acidosis and renal impairment updated and text on administration of iodinated contrast agents and surgery reworded following article 31 for metformin containing products,
4.5 Repositioning of text, text on alcohol and iodinated contrast agents re-worded. Information on medicinal products which affect renal function/lactic acidosis added following article 31 for metformin containing products.
5.1 Minor editorial changes
5.2 Minor editorial changes
10 revision date
Updated on 23 December 2016
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 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 29 April 2015
Reasons for updating
- 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
Updated on 29 April 2015
Reasons for updating
- New PIL for medicines.ie