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.