Class 4 MHRA drug alert – Xonvea 10 mg/10 mg gastro-resistant tablets (Alliance Pharmaceuticals Limited)

Class 4 MHRA drug alert – Xonvea 10 mg/10 mg gastro-resistant tablets (Alliance Pharmaceuticals Limited)

October 16, 2019

Class 4 MHRA drug alert – Xonvea 10 mg/10 mg gastro-resistant tablets (Alliance Pharmaceuticals Limited)

Drug alert number: EL (19)A/26

Date issued: 16 October 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Xonvea 10 mg/10 mg gastro-resistant tablets (Alliance Pharmaceuticals Limited)

Alliance Pharmaceuticals Ltd has informed MHRA that the Patient Information Leaflet (PIL) is missing the possible side effects from post-marketing experience and the associated class effects that are documented in the Summary of Product Characteristics (SmPC). It is important that any patients who notice the symptoms seek immediate medical advice. Alliance Pharmaceuticals Ltd is in process of updating the PIL and this will be effective on release of all new batches to the market.

Batch Number Expiry Date Pack Size First Distributed
1510 30/11/2021 1 x 20 25/09/2018
1525 31/12/2021 1 x 20 05/12/2018
1527 31/01/2022 1 x 20 17/12/2018

Advice for healthcare professionals
When dispensing this product, please check the Marketing Authorisation Holder and the batch number. If any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information. The current SmPC includes the missing side effects and class effects:

https://www.medicines.org.uk/emc/product/9344

For more information or medical information queries, please contact: medinfo@alliancepharma.co.uk

PL number: PL 16853/0147

To view the alert please visit the GOV.uk website.



Posted in:


More Latest News >

CPCS Frequently Asked Questions

With the Community Pharmacist Consultation Service (CPCS) now bedding in, below you will find a selection of questions about the...