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Briviact (brivaracetam) in Class 4 alert

Colourant information missing on PILs

April 4th 2023

Tagged: MHRA alert


Several batches of Briviact (brivaracetam) 75mg and 100mg film-coated tablets are included in a Class 4 medicines defect information alert.

Due to a formatting error of the Patient Information Leaflet (PIL), incorrect and missing information about the colorant ingredients of the tablet coating was listed in Section 6 of the PIL.

The PIL for two batches of the 75mg tablets omits iron oxide red (E172) from the list of coating ingredients. Meanwhile, the PIL for 12 batches of the 100mg tablets omits iron oxide black (E172) from the list of coating ingredients.

Where possible, healthcare professionals are asked to please provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine.