Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39

Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles).

DMRC Number: DMRC-36144551

Company name:Zydus Pharmaceuticals UK Ltd

Product description: 

Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution

PL: 58839/0026

Active Ingredient: topiramate

SNOMED code: 44000111000001109

Details of the affected batch:

Brief description of problem: 

Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles). The instruction for use is missing the step to shake well prior to opening and before each use. These packs are Prescription Only Medicines (POM) and are intended for use in both adult patients and paediatric patients.

Advice to Healthcare Professionals: 

Healthcare professionals and retailers are advised to review the information contained within this notification and, where possible, inform customers that Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (Pack Size 150ml and 280ml bottles) should be “shaken well prior to opening and before each use”.

Healthcare professionals should continue to prescribe and dispense the product as the batches listed are not being recalled.

Advice to Patients: 

Please shake the bottle prior to opening and before each use. 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. These batches are not being recalled and should not cause harm if taken without shaking

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For all enquires on this product please email DrugSafety@ZydusUK.com or telephone 0800 9956034.

To access the full recall: 

Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39