Class 4

Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13

Ethigen Limited have informed the MHRA that the Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information.

MDR Number: MDR 221-03/23

Company name: Ethigen Limited

Product description: Briviact 75 mg film-coated tablets, PLPI 18716/0146

SNOMED Code: 37622711000001100

Details of the affected batch:

Lot no

Expiry Date

Pack Size

First Distributed

340132

30/09/2024

56

15-Nov-22

332075

28/02/2025

56

06-Dec-22

Active Pharmaceutical Ingredient: brivaracetam 

Product description: Briviact 100 mg film-coated tablets PLPI 18716/0147

SNOMED Code: 37622711000001101

Lot no

Expiry Date

Pack Size

First Distributed

332076

28/02/2025

56

09-Mar-22

329941

31/12/2024

56

09-May-22

337225

30/04/2025

56

30-May-22

332072

31/03/2025

56

01-Jun-22

329491

31/12/2024

56

08-Jun-22

337216

31/05/2025

56

09-Jun-22

339975

30/06/2025

56

27-Jun-22

337216

31/05/2025

56

29-Jul-22

343194

30/09/2025

56

14-Nov-22

349497

31/10/2025

56

16-Nov-22

343190

30/09/2025

56

12-Dec-22

349527

30/11/2025

56

14-Feb-23

Active Pharmaceutical Ingredient: brivaracetam

Brief description of problem:

Ethigen Limited have informed MHRA that 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:

Briviact 75mg film-coated tablets

The erroneous PIL packed with the affected batches of Briviact 75mg film-coated tablets contains the following text:

Coating:

poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide black (E172)).

The correct version of the PIL should include the following text (missing information in bold):

Coating:

poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

 

Briviact 100 mg film-coated tablets


The erroneous PIL packed with the affected batches of Briviact 100mg film-coated tablets contains the following text:

Coating:

poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172).

The correct version of the PIL should include the following text (correct information in bold):

Coating:

poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide black (E172).

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the above batches of the product. Where possible, 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. These are available on the MHRA website by entering the product licence (PLPI) numbers. Alternatively, these may also be accessed via the links below:

Briviact 75mg film-coated tablets

https://mhraproducts4853.blob.core.windows.net/docs/88b1c0990ec137db964195d3119b2edf0ee234b7

Briviact 100mg film-coated tablets

https://mhraproducts4853.blob.core.windows.net/docs/f63a096dafd7f046da5c0ef7334000b39a2b9d28

Upon request, Ethigen Limited will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

Advice to Patients:

This notification relates to a typographical error in the Patient Information Leaflet (PIL) relating to the ingredients of the tablet coating of the medicine. Patients do not need to take any action as the medicine itself is not affected.

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 the Regulatory Affairs Department at regulatory@ethigen.co.uk.

To access the full recall:

https://assets.publishing.service.gov.uk/media/64255a222fa8480013ec0f8a/EL_23_A13.pdf