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Class 4 Medicines Defect Notification: Azithromycin 250 mg capsules

Outdated Patient Information Leaflet supplied

Jubilant Pharmaceuticals NV has warned of the wrong Patient Information Leaflet (PIL).

They have informed the Medicines and Healthcare products Regulatory Agency (MHRA) that some batches of Azithromycin contain an outdated PIL which lacks important updated safety information. Healthcare professionals are advised to review the information contained within the notification, and take this into account when prescribing.

Read the notification on the Gov.uk website about Azithromycin 250 mg capsules, EL(25)A/11.

When products from batches included in the table are supplied or dispensed, patients should be made aware of the missing information which is summarised in the ‘Advice for Patients’ box in the notification and provided in Appendix 2. As the patients would not find the current PIL in the packs, patients should be advised that the latest PIL for Azithromycin capsules is available on the MHRA website.