Class 4 drug alert – Caution in Use – Xonvea gastro-resistant tablets 10mg/10mg

16 Oct 2019

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Xonvea gastro-resistant tablets 10mg/10mg

Ref: EL (19)A/26

16 October 2019

Xonvea gastro-resistant tablets 10mg/10mg

(Manufactured by Alliance Pharmaceuticals Limited)

PL 16853/0147

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for specific batches of Xonvea gastro-resistant tablets 10mg/10mg.

Batch Number Expiry Date Pack Size First Distributed
1510 30/11/2021 1 x 20 tablets 25 September 2018
1525 31/12/2021 1 x 20 tablets 05 December 2018
1527 31/01/2022 1 x 20 tablets 17 December 2018

Alliance Pharmaceuticals Ltd has stated that the Patient Information Leaflet (PIL) has not been updated with the possible side effects from post-marketing experience and the related class effects as listed in the Summary of Product Characteristics (SPC).

A full list of the information that is missing from the PIL can be found in the MHRA drug alert document

All patients should seek immediate medical attention if they notice any of the side effects or class effects listed within the SPC.

Pharmacists and pharmacy teams should check the Marketing Authorisation holder and the batch number when dispensing the product. When dispensing any of the affected batches, ensure patients are aware of the missing information using the up-to-date SPC available on the eMC website.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team October 2019.