MHRA reports error on topiramate packaging

Zydus Pharmaceuticals UK has reported an error on the packaging and patient information leaflet of a few batches of their topiramate medication, often prescribed for epilepsy, to the Medicines and Healthcare products Regulatory Agency (MHRA).

Batches TPR24001 (280ml size), TPR24002 (280ml size) and TPR24003 (150ml size) of the ‘topiramate Zydus Pharmaceuticals UK 20mg/ml oral solution’ have been affected by the misprint.

The instructions for use on the packaging and the patient information leaflet are missing the step to shake well before opening the medication and before each use.

The MHRA is advising people prescribed the medication to shake the bottle before opening and before each use. It said the medication is not being recalled and “should not cause harm if taken without shaking”.

The MHRA writes: “Patients in receipt of these batches should continue to take the medicine as prescribed by your healthcare professional. Never stop taking medicines such as topiramate without medical advice, especially if they are being used for epilepsy.

“Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.”

Healthcare professionals are advised to tell patients to shake the bottle well before use and to continue to prescribe the medication.