Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61

L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, dated July 2021.

DMRC Number: DMRC-34033472

Company name: Brillpharma Limited

Product description: Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, PL 40496/0009 SNOMED Code 38072711000001102

Details of the affected batch: 

Brief description of problem:

L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed in the table above for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, dated July 2021. The latest PIL was authorised in 2023.

The out of date PIL from 2021 is missing information related to the following sections “What you need to know before you take Oxybutynin hydrochloride Brillpharma”; “Warnings and Precautions”; “In particular tell your doctor if you are taking any of the following”; “Pregnancy, breast-feeding and fertility”; “Not known: cannot be estimated from the available data”. The latest PIL, authorised in 2023, includes updated information related to the sections mentioned above.

Advice to Healthcare Professionals:

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution. When product from batch included in the table is supplied or dispensed, please ensure that patients are aware of the missing information. The electronic versions of the PIL is up to date and can be accessed via the following link:

https://www.medicines.org.uk/emc/files/pil.13841.pdf

Advice to Patients:

Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are  warnings in the updated patient information leaflet (PIL) which accompanies the medicine, for “What you need to know before you take Oxybutynin hydrochloride Brillpharma”; “Warnings and Precautions”; “In particular tell your doctor if you are taking any of the following”; “Pregnancy, breast-feeding and fertility”; “Not known: cannot be estimated from the available data”). The updated PIL can be accessed via the following link:

https://www.medicines.org.uk/emc/files/pil.13841.pdf

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine, you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the 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 medical information enquiries please contact info@brillpharma.co.uk.

For stock control enquiries please contact Telephone +44 (0) 1582 545500

To access the full recall: Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61