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AstraZeneca Pharmaceuticals (Ireland) DAC

College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information Direct Line: 1800 800 899 Freephone
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +353(0)1 609 7100 Supply & non-medical enquiries
Medical Information Facsimile: +44 (0)1582 838 003
Summary of Product Characteristics last updated on medicines.ie: 19/06/2017
SPC NEXIUM 20 mg Tablets

When a pharmaceutical company changes an SPC or PIL, 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 19/06/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   12-Jun-2017
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 27/01/2017 and displayed until 19/06/2017
Reasons for adding or 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
Date of revision of text on the SPC:   24-Jan-2017
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 28/04/2016 and displayed until 27/01/2017
Reasons for adding or 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
Date of revision of text on the SPC:   18-Apr-2016
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 08/10/2014 and displayed until 28/04/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation
Date of revision of text on the SPC:   24-Sep-2014
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 06/03/2014 and displayed until 08/10/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Feb-2014
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 09/10/2013 and displayed until 06/03/2014
Reasons for adding or 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
Date of revision of text on the SPC:   14-Aug-2013
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 28/06/2013 and displayed until 09/10/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Jun-2013
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 updated to '14th June 2013'.
Updated on 23/11/2012 and displayed until 28/06/2013
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Nov-2012
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 22/10/2012 and displayed until 23/11/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   10-Oct-2012
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 04/07/2012 and displayed until 22/10/2012
Reasons for adding or 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
Date of revision of text on the SPC:   20-Jun-2012
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 24/05/2012 and displayed until 04/07/2012
Reasons for adding or 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
Date of revision of text on the SPC:   11-May-2012
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 06/10/2011 and displayed until 24/05/2012
Reasons for adding or 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
Date of revision of text on the SPC:   30-Sep-2011
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 22/07/2011 and displayed until 06/10/2011
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Esomeprazole magnesium trihydrate