Nexium Control 20 mg gastro-resistant tablets
*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 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
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
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
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
Updated on 21 August 2014
Reasons for updating
- New PIL for new product