MHRA Class 4 Medicines Defect Notification: Various Chemidex Pharma Ltd Products
MHRA Class 4 Medicines Defect Notification: Various Chemidex Pharma Ltd Products
Drug alert number: EL(25)A/21
Date issued: 13 May 2025
Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.
DMRC reference number:DMRC-35334505
Company name: Chemidex Pharma Ltd
Product name: Brilique 90mg tablets PLPI: 16369/2052
Medicine Details
Predfoam 20mg/dose Rectal Foam, Prednisolone 20mg/dose Rectal Foam
PL17736/0130
Active Ingredient: prednisolone
SNOMED code: 38753811000001101
Beclometasone dipropionate 0.25 mg/g Cream
PL17736/0127
Active Ingredient: beclometasone
SNOMED code: 18436411000001103
Beclometasone dipropionate 0.25 mg/g Ointment
PL17736/0268
Active Ingredient: beclometasone dipropionate
SNOMED code: 18434811000001108
Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Cream
PL17736/0100
Active Ingredient: clobetasol propionate, neomycin sulfate, nystatin
SNOMED code: 18670711000001106
Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Ointment
PL17736/0101
Active Ingredient: clobetasol propionate, neomycin sulfate, nystatin
SNOMED code: 18670911000001108
Hydrocortisone 0.5% Cream
PL: 17736/0090
Active Ingredient: hydrocortisone
SNOMED code: 14943211000001105
Hydrocortisone 2.5% Cream
PL:17736/0092
Active Ingredient: hydrocortisone
SNOMED code: 14943911000001101
Hydrocortisone 2.5% Ointment
PL: 17736/0095
Active Ingredient: hydrocortisone
SNOMED code: 14944911000001104
Affected Lot Batch Numbers
See Download Document for batch numbers
Background
Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.
The batches listed as ‘not yet distributed’ have also been packed with the PIL that is missing the additional side effect information. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification and the expected distribution dates for these batches will take place from May 2025.
Advice for healthcare professionals
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products
When product from batches included in the tables are supplied or dispensed, please ensure that patients are aware of the missing information.
The missing information is:
PIL Section 2
Contact your doctor if you experience blurred vision or other visual disturbances.
PIL Section 4
Side effects where the frequency is not known: Blurred vision.
See full alert here.
Advice for Patients:
Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. The quality of the impacted batches is not affected which is why the products are not being recalled.
There is some missing information in the patient leaflet which is presented below:
Section 2
Contact your doctor if you experience blurred vision or other visual disturbances.
Section 4
Side effects where the frequency is not known: Blurred vision.
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 their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information
For medical information enquiries please email essentialpharmaUK@EU.ProPharmaGroup.com or telephone +44 (0)1423 850700.
For stock control enquiries please email commercial@essentialpharmagroup.com.
