Source: MHRA 30.3.23
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 name
Briviact 75 mg film-coated tablets, PLPI 18716/0146
SNOMED Code
37622711000001100
| 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 name
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 the 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 for 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
Briviact 100mg film-coated tablets
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 for 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.
Further Information
For medical information and stock control queries please contact the Regulatory Affairs Department at regulatory@ethigen.co.uk.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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