NEXIUM 40 mg Tablets
*Company:
Grunenthal Pharma Ltd.Status:
No Recent UpdateLegal 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 02 August 2023
File name
ie-pl-nexium-tablets-ipha.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 May 2023
File name
ie-pl-nexium-tablets-ipha.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 31 January 2023
File name
ie-spc-nexium-40mg-tabs-ipha.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 January 2022
File name
ie-spc-nexium-40mg-tabs-ipha.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 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
Approval of Type II variation to include information regarding AGEP and DRESS
Updated on 24 January 2022
File name
ie-pl-nexium-tablets-ipha.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Approval of Type II variation to include information regarding AGEP and DRESS
Updated on 17 January 2021
File name
ie-spc-nexium-40mg-tabs-v2d2-clean-ipha.pdf
Reasons for updating
- 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 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:
Added information on sodium content
Section 4.8
update to adverse event reporting to HPRA
Updated on 17 January 2021
File name
ie-pl-nexium-tablets-v3-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Added information on sodium content.
Nexium contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Updated on 12 June 2020
File name
ie-pl-nexium-tablets-v2-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
update to adverse event reporting information
edioricah changes to section 6
Updated on 28 March 2020
File name
ie-pl-nexium-tablets-MA-transfer-clean-ipha.pdf
Reasons for updating
- XPIL Created
Updated on 24 March 2020
File name
ie-spc-nexium-40mg-tabs-clean-ipha.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Marketing authorisation transferred to Grunenthal Pharma Ltd., Ireland and associated product licence number change
Updated on 24 March 2020
File name
ie-pl-nexium-tablets-MA-transfer-clean-ipha.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Marketing authorisation transferred to Grunenthal Pharma Ltd., Ireland and associated product licence number change
Updated on 15 November 2019
File name
20191104-ie-pil-nexium-tablets-grt-addition-GI 19 0001.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 January 2019
File name
20190107-Package Leaflet-ie-Nexium-tablets-20 40mg MAH transfer GI 18 0029.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 16 January 2019
File name
20190107-SPC-ie-Nexium-tablets-40mg MAH transfer GI 18 0033.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7 – Marketing Authorisation Holder details updated
Section 8 – Marketing Authorisation numbers updated
Section 10 – date of revision updated
Updated on 19 June 2018
File name
2018-06-18 cPIL Nexium 20 and 40mg Tabs UIM GI 18 0019 Reims.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 4.2- The subheading ‘posology’ has been added
Section 4.7- Minor editorial update
Section 4.8- ‘Fundic gland polyps (benign)’ has been added as an Undesirable Effect
Section 10- Date of revision updated.
Updated on 14 June 2017
File name
PIL_7708_147.pdf
Reasons for updating
- New PIL for new product
Updated on 14 June 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 27 January 2017
Reasons for updating
- 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 4.4: Additional information on PPI’s has been added under sub-section ‘Interference with laboratory tests’.
Section 5.1: Additional information on recommendation of Chromogranin A and PPI:S has been added.
Section 10: Date of revision of the text has been revised.
Updated on 26 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 28 April 2016
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 5.2 - 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
Change to section 4.2 – minor editorial changes to bring in line with QRD
Change to section 4.4 – Inclusion of paragraph regarding Subacute cutaneous lupus erythematosus (SCLE)
Change to section 4.8 – inclusion of the side effect SCLE
Change to section 5.2 – minor editorial changes to bring in line with QRD
Change to Section 10 – update to date of revision of text.
Updated on 27 April 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 10 October 2014
Reasons for updating
- Improved electronic presentation
Updated on 09 October 2014
Reasons for updating
- Change to section 10 - Date of revision of the text
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
section 10 - updated date of revision
Updated on 03 October 2014
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 06 March 2014
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)
Free text change information supplied by the pharmaceutical company
- Section 10 date of revision
- Section 4.8 addition of hypokalaemia to section under Metabolism and nutrition disorders
Updated on 10 October 2013
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 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 - Input of Chromogranin A
Section 4.5 - Input of pharmacokinetic (PK)/ pharmacodynamic (PD) interaction between clopidogrel and esomeprazole and interaction with Tacromilus
Section 4.8 - Renal and urinary disorders, renal failure added
Section 5.1 - More detail on interaction of Chromogranin A and tumours
Section 10 - Updated date of revision
Updated on 08 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 28 June 2013
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)
Free text change information supplied by the pharmaceutical company
Amend Renal and urinary disorders section to add: “; in some patients renal failure has been reported concomitantly”
Section 10
Date of revision update to '14th June 2013'.
Updated on 15 May 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 26 November 2012
Reasons for updating
- 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 10
Last revision date modified to reflect IMB issued SmPC.
Updated on 22 October 2012
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)
Free text change information supplied by the pharmaceutical company
Section 4.4
PhVWP wording included regarding hypomagnesaemia and risk of fracture.
Section 4.8
Frequency of hypomagnesaemia changed from “very rare” to “not known” and fracture of the hip, wrist or spine added as uncommon, as per PhVWP wording.
Section 10
Updated to 10th October 2012.
Updated on 18 October 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 04 July 2012
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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- 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
Section 4.4
Addition of information about vitamin B12 absorption.
Section 4.5
Revision of information about ‘gastric acid suppression (initial paragraph).
Addition of information under sub-heading ‘Unknown mechanism’ – related to methotrexate.
Section 4.8
Further information provided about ADR hypomagnesaemia – under ‘Metabolism and nutrition disorders’.
Addition of ADR microscopic colitis – under ‘Gastrointestinal disorders’.
Section 5.1
Addition of information about paediatric GORD patients receiving long-term PPI treatment.
Section 10
Date of revision updated to 20th June 2012
Updated on 28 June 2012
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 24 May 2012
Reasons for updating
- 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 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 4.5
Addition of information about about esomeprazole interaction with cilostazol.
Section 5.1
Addition of information about risk of Clostridium difficile infection in hospitalised patients.
Section 10
Date of revision changed to 11th May 2012.
Updated on 21 May 2012
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 06 October 2011
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 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 added re about ‘Interference with laboratory tests’
Section 4.5 - Information added about interaction with St John’s wort, rifampicin and digoxin
Section 5.1 - Information added about the increased levels of Chromogranin A
Updated on 05 October 2011
Reasons for updating
- Change of contraindications
- Change to drug interactions
- Change to date of revision
Updated on 22 July 2011
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 July 2011
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 22 March 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 23 October 2009
Reasons for updating
- Change to drug interactions
Updated on 03 August 2009
Reasons for updating
- Change to MA holder contact details
Updated on 11 June 2009
Reasons for updating
- Change to, or new use for medicine
- Change to dosage and administration
- Change to side-effects
Updated on 23 December 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to, or new use for medicine
- Change to information about pregnancy or lactation
- Change due to user-testing of patient information
- Change to side-effects
- Change to storage instructions
- Change to appearance of the medicine
Updated on 21 August 2007
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 23 May 2007
Reasons for updating
- Change to, or new use for medicine
- Change to drug interactions
- Change to dosage and administration
Updated on 27 March 2007
Reasons for updating
- Change to drug interactions
Updated on 29 January 2007
Reasons for updating
- Change in co-marketing arrangement
Updated on 30 May 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 18 November 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 10 November 2004
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 06 October 2004
Reasons for updating
- Change to date of revision
Updated on 28 July 2004
Reasons for updating
- New PIL for medicines.ie