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Pfizer Consumer Healthcare

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 14/12/2017
SPC Nexium Control 20 mg gastro resistant 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 14/12/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Nov-2017
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 14/12/2016 and displayed until 14/12/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   15-Sep-2016
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 13/10/2016 and displayed until 14/12/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   15-Sep-2016
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 14/12/2015 and displayed until 13/10/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   23-Nov-2015
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 26/08/2014 and displayed until 14/12/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Esomeprazole magnesium trihydrate