Class 4

Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21

Added

Author

Cathy

Categories

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 Number: DMRC-35334505

Company name: Chemidex Pharma Ltd

Product descriptions: 

  • Predfoam 20mg/dose Rectal Foam, Prednisolone 20mg/dose Rectal Foam: PL17736/0130, SNOMED code: 38753811000001101
  • Beclometasone dipropionate 0.25 mg/g Cream: PL17736/0127, SNOMED code: 18436411000001103
  • Beclometasone dipropionate 0.25 mg/g Ointment: PL17736/0268, SNOMED code: 18434811000001108
  • Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Cream: PL17736/0100, SNOMED code: 18670711000001106
  • Clobetasol propionate/neomycin sulfate/nystatin 0.5 mg/5 mg/100,000 IU/g Ointment: PL17736/0101, SNOMED code: 18670911000001108
  • Hydrocortisone 0.5% Cream: PL: 17736/0090, SNOMED code: 14943211000001105
  • Hydrocortisone 2.5% Cream: PL:17736/0092, SNOMED code: 14943911000001101
  • Hydrocortisone 2.5% Ointment: PL: 17736/0095, SNOMED code: 14944911000001104

Details of the affected batches:  See Alert Document for batch numbers

Brief description of problem:

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 to 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.

Advice to 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 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 email essentialpharmaUK@EU.ProPharmaGroup.com or telephone +44 (0)1423 850700.

For stock control enquiries please email commercial@essentialpharmagroup.com.

To access the full alert: Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21