NEXIUM 40 mg Tablets *

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 17 January 2021

File name

ie-spc-nexium-40mg-tabs-v2d2-clean-ipha_1610916885.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_1610916675.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_1591975418.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_1585050440.pdf

Reasons for updating

  • XPIL Created

Updated on 24 March 2020

File name

ie-spc-nexium-40mg-tabs-clean-ipha_1585050500.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_1585050440.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_1573821096.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_1547654444.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_1547654685.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

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 14 June 2017

File name

PIL_7708_147.pdf

Reasons for updating

  • New PIL for new product

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

Multiple changes throughout the SmPC due to updating SmPC in line with QRD template.
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

Section 4.8
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

None provided

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