Nexium Control 20 mg gastro resistant hard capsules
*Company:
Haleon Ireland LimitedStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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