MHRA Class 4 Medicines Defect Information: Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets (Mylan)

Class 4 Medicines Defect Information: Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets (Mylan)

Drug alert number: EL (24)A/22

Date issued: 17 June 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets (Mylan)

Company name: Viatris UK Healthcare Ltd

Product name: Oxcarbazepine Mylan 150 mg Film-Coated Tablets PL 04569/0779

SNOMED Code: 13437411000001102

Batch Number Expiry date Pack size First distributed
A4659 03/2026 50 29/02/2024
A4660 04/2026 50 Not yet distributed

Product name: Oxcarbazepine Mylan 300 mg Film-Coated Tablets PL 04569/0780

SNOMED Code: 13437611000001104

Batch Number Expiry date Pack size First distributed
N3560 02/2026 50 05/02/2024
A4705  02/2026 50 18/03/2024

Product name: Oxcarbazepine Mylan 600 mg Film-Coated Tablets PL 04569/0781

SNOMED Code 13437811000001100

Batch Number Expiry date Pack size First distributed
M3556 12/2025 50 09/02/2024

Active Pharmaceutical Ingredient: Oxcarbazepine

 

Brief description of the problem

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the above specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg 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 the notification.

Advice for 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.

View full alert here.

Advice for 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.

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).

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