Nexium Control 20 mg gastro-resistant tablets

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

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’.

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’.

- 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"

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

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.

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