Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets, EL (24)A/22

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150mg, 300mg & 600mg Film-Coated Tablets do not contain the most up to date safety information.

MDR Number: MDR 043-05/24

Company name: Viatris UK Healthcare Ltd

Product description: 

Oxcarbazepine Mylan 150mg Film-Coated Tablets PL 04569/0779 SNOMED Code 13437411000001102

Oxcarbazepine Mylan 300mg Film-Coated Tablets PL 04569/0780 SNOMED Code 13437611000001104

Oxcarbazepine Mylan 600mg Film-Coated Tablets PL 04569/0781 SNOMED Code 13437811000001100

Brief description of problem:

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the above specified batches of Oxcarbazepine 150mg, 300mg & 600mg Film-Coated Tablets do not contain the most up to date safety information. The affected sections of the PIL are summarised in Appendix 1 of this notification.

Advice to Healthcare Professionals:

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Due to supply considerations, batch A4660 that has yet to be distributed will not be repackaged with the updated PIL prior to distribution. Viatris UK Healthcare Ltd has confirmed that all future batches of the product will contain the updated PIL.

Healthcare professionals are advised to ensure that patients are aware of the updated safety information when dispensing the affected batches of product. Please provide a copy of the updated PIL and remind the patient to read the entire leaflet before taking the medicine. The electronic versions of the PIL are up to date and can be accessed via the following links:

Oxcarbazepine Mylan 150 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Oxcarbazepine Mylan 300 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Oxcarbazepine Mylan 600 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Hard copies of the updated PIL can also be requested from Viatris UK Healthcare Ltd (see contact details below) so that current stock in the dispensary can be supplemented with the correct PIL.

Advice to Patients:

The medicine itself is not affected and patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. 

Patients should be aware that the Patient Information Leaflet included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected information is summarised in Appendix 1 of this notification.  The up-to-date version of the Patient Information Leaflet can be accessed via the links above. Please read this before taking the medicine.

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

Company contacts for further information:

For medical information and stock control queries please contact:

Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com.

 Customer Services can be reached at +44 (0)1707 853 000 (select option 2).

To access the full recall: Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets EL (24)A/22