Nexium Control 20 mg gastro-resistant tablets

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Pharmacy Only: Non-prescription

Updated on 05 December 2024

File name

MASTER-IE-PIL-NEXIUM TABS_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 TABS_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 TABLETS_PIL_text version_June 2024.pdf

Reasons for updating

  • Change to further information section

Updated on 23 January 2024

File name

Nexium Control Tablets PIL.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 January 2024

File name

MASTER-Nexium Control TABLETS_Feb 2021.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 TABLETS_SmPC Approved Feb 2021.pdf

Reasons for updating

  • 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 sodium excipient warning in Section 4.4. 

Sodium

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

Updated on 15 March 2022

File name

Nexium Control Tablets 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

Addition to sodium warning to Section 2 and Section 6 of the patient information leaflet. Nexium Control contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

Updated on 15 January 2021

File name

8601_Nexium Control Tablets_SmPC_20_029_clean.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

8601_IE_Nexium control tablets_PIL_20_029_PAA148574_v05_v5_FVID1028852 (1).pdf

Reasons for updating

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

Updated on 01 November 2018

File name

Nexium Control PIL 18 130 for upload.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 October 2018

File name

Nexium Control TABLETS_SmPC_18_130_v1 clean.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

8601_Nexium Control TABLETS_SmPC_17_117_v1 clean.docx

Reasons for updating

  • Other

Legal category:Supply through pharmacy only

Updated on 22 December 2017

File name

PIL_16077_981.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • 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 14 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 14 December 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

- In Section 4.8 (undesirable effects), fundic gland polyps (benign) was added to common gastrointestinal disorders (this change was following a PRAC for esomeprasole).

The following sections were amended with predominantly administrative changes, following a line extension approval to bring it in line with the capsules SmPC:

- In Section 2 (QUALITATIVE AND QUANTITATIVE COMPOSITION), the colon was removed from the sentence "Excipient(s) with known effect:".

- In Section 3 (Pharmaceutical form), the dimensions of the tablet were added (14 mm x 7 mm) and the desciption of the engraving was corrected from "20 mg" to "20 mG".

- In Section 4.2 (Posology and method of administration), Pediatric Population, the following sentence was changed from "in the indication:" to "for the indication of".

- In Section 4.3 (Contraindications), "esomeprazole" was changed to "the active substance".

- In Section 4.4 (Special warning and precautions for use), the paragraph about Sucrose was moved to the end of the section and the word "medicine" was changed to "medicianal product".

- In Section 4.5 (Interaction with other medicinal products), Clopidogrel, "ASA" was changed to "acetylsalicylic acid". Formatting was also amended.

- In Section 4.6 (Fertility, Pregnancy and Lactation), spelling has been corrected to "breast-feeding".

- In Section 4.7 (Effects on ability to drive and use machines), grammatical change from "a minor influence" to "minor influence".

- In Section 4.8 (Undesirable effects), Reporting of suspected adverse reactions, contact details have been ammended.

- In Section 5.1 (Pharmacodynamic properties), Mechanism of action, grammatical change adding brackets was made: from "the enzyme H+K+ ATPase – the acid pump" to "the enzyme H+K+ ATPase (the acid pump)"; also spelling was corrected from "Clinical Efficacy" to "Clinical efficacy" (removed capital letter).

- In Section 7 (MAH), "UK" was corrected to "United Kingdom"

Updated on 14 December 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects) market specific adverse event reporting contact details have been added as shown below:

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system in the United Kingdom: Yellow Card Scheme Website www.mhra.gov.uk/yellowcard

In Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

In Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt

email: postlicensing.medicinesauthority@gov.mt

Updated on 13 October 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Class label update for proton pump inhibitors (PPIs) esomeprazole, concerning elevated circulating levels of Chromogranin A.

Additional text in Section 4.4:

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.


Additional text in Section 5.1:

During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.

 

Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.

Updated on 14 December 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precations for use) the following has been added:

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

 


In section 4.8 (undesirable effects) the following has been added:

Not known frequency: Subacute cutaneous lupus erythematosus (see section 4.4).

Updated on 04 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 22 May 2015

Reasons for updating

  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 26 August 2014

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 August 2014

Reasons for updating

  • New PIL for new product