Nexium Control 20 mg gastro resistant hard capsules

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Pharmacy Only: Non-prescription

Updated on 05 December 2024

File name

MASTER-IE-PIL-NEXIUM CAPS_Implemented 15Nov2024.pdf

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Marketing Authorisation Holder

Haleon Ireland Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland 

Updated on 05 December 2024

File name

MASTER-IE-SPC-NEXIUM CAPS_Implemented 15Nov2024.pdf

Reasons for updating

  • Change to MA holder contact details

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

7.        MARKETING AUTHORISATION HOLDER


Haleon Ireland Dungarvan Limited,

Knockbrack,

Dungarvan,

Co. Waterford,

Ireland

Updated on 18 June 2024

File name

Nexium Control 20 mg gastro-resistant hard CAPSULES_PIL_text version_June 2024.pdf

Reasons for updating

  • Change to further information section

Updated on 23 January 2024

File name

Nexium Control Capsules PIL.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 November 2023

File name

MASTER_Nexium Control CAPSULES_SmPC_Feb2021.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through pharmacy only

Updated on 13 November 2023

File name

MASTER_Nexium Control CAPSULES_SmPC_Feb2021.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through pharmacy only

Updated on 19 May 2023

File name

1-3-1-ema-combined-h-2618-en-clean-proposed IT14 26Jan.pdf

Reasons for updating

  • Other

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change in the name of a manufacturing site of the finished product (including batch release). The change of name of the finished product manufacturing site and batch release is from ‘Pfizer Consumer Manufacturing Italy S.r.l.’ to ‘Haleon Italy Manufacturing S.r.l.’.

The change in the name of the manufacturing site will not impact the address of the manufacturing site, which remains as ‘Via Nettunense, 90, 04011 Aprilia (LT), Italy’.

The entity of the batch release site remains the same legal entity

Updated on 15 March 2022

File name

Nexium Control CAPSULES SmPC Approved Feb 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to excipient warnings to add sodium and allura red. 

Excipient(s) with known effect

Each gastro‑resistant hard capsule contains 11.5 mg sucrose and 0.01 mg allura red AC (E129).

For the full list of excipients, see section 6.1.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium free’.

Allura red AC (E129)

This medicinal product contains azo colouring agent, Allura red AC (E129), which may cause allergic reactions.

Updated on 15 March 2022

File name

Nexium Control Capsules Feb 2021 Approved.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Update to excipient warnings to add sodium and allura red. 

Nexium Control contains sucrose, sodium and allura red AC (E129)

Nexium Control contains sugar spheres, which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nexium Control contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium free’.

Nexium Control contains azo colouring agent, Allura red AC (E129), which may cause allergic reactions.

Updated on 15 January 2021

File name

8603_Nexium Control CAPSULES_SmPC_20_015_20_030_Nov 2020.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 15 January 2021

File name

8603_Nexium Control Capsules_PIL_20_030.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 December 2018

File name

8603_Nexium Control CAPSULES_SmPC_18_243.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update of the shelf life to 3 years

Updated on 01 November 2018

File name

Nexium Control Caps PIL for upload.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 October 2018

File name

Nexium Control CAPSULES_SmPC.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 12 July 2018

File name

8603_Nexium Control CAPSULES_SmPC_17_117 - clean.docx

Reasons for updating

  • Other

Legal category:Supply through pharmacy only

Updated on 22 December 2017

File name

PIL_17197_710.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 December 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 28 August 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 18 August 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 28 June 2017

Reasons for updating

  • New PIL for new product
  • Submitted in error