Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Epiduo 0.1% / 2.5% gel (45 g), EL (22)A/52

Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.

MDR Number: MDR 031-12/22

Company name: Galderma (U.K.) Limited

Product description: Epiduo 0.1% / 2.5% gel (45 g), PL 10590/0057

Details of the affected batch:

Brief description of problem:

Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the above batches of Epiduo 0.1% / 2.5% gel contains outdated safety information regarding pregnancy.

Extract from PIL section 2 (“What you need to know before you use Epiduo”):

The erroneous version of the leaflet packed with these batches contains the following wording:

Do not use Epiduo:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Pregnancy and breast-feeding

Epiduo should not be used during pregnancy

If you fall pregnant while taking Epiduo, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up.

…

Ask your doctor or pharmacist for advice before taking any medicine.

 

The correct version of the leaflet should include the following wording (missing/changed information highlighted in bold):

Do not use Epiduo:

• If you are pregnant
• If you are planning a pregnancy
• If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Pregnancy and breast-feeding

DO NOT use Epiduo if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.

If you fall pregnant while taking Epiduo, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up.

…

Ask your doctor or pharmacist for advice before taking any medicine.

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. This is available via the link below:

Epiduo 0.1%/2.5% Gel - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)

Where available, Galderma (U.K.) Limited will be providing the updated PIL with all future deliveries for the affected batches. Upon request, Galderma (U.K.) 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:

If you are pregnant or planning a pregnancy you should be aware that the Patient Information Leaflet (PIL) in the above batches of Epiduo 0.1% / 2.5% gel does not contain the most up-to-date safety information. Specifically, you are reminded that you should not use this product when pregnant and furthermore you should not use the product when planning a pregnancy.

Please inform your doctor if you are pregnant or planning a pregnancy.

Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com

For stock control queries, please contact: sales.uk@galderma.com

Full recall