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informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.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 name
Epiduo 0.1% / 2.5% gel (45 g), PL 10590/0057
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 1324283 | 30-Nov-23 | 1 x 45g | 18-Mar-22 |
| 1324288 | 30-Nov-23 | 1 x 45g | 18-Mar-22 |
| 2324207 | 31-Jan-24 | 1 x 45g | 09-Jun-22 |
| 2324212 | 31-Mar-24 | 1 x 45g | 31-May-22 |
| 2324218 | 30-Apr-24 | 1 x 45g | 14-Jul-22 |
| 2324227 | 30-Apr-24 | 1 x 45g | 26-Jul-22 |
| 2324228 | 30-Apr-24 | 1 x 45g | 12-Sep-22 |
| 2324228A | 30-Apr-24 | 1 x 45g | 30-Sep-22 |
| 2324237 | 31-May-24 | 1 x 45g | 30-Nov-22 |
| 2324238 | 31-May-24 | 1 x 45g | not yet distributed |
| 2324239 | 30-Jun-24 | 1 x 45g | not yet distributed |
| 2324248 | 31-Aug-24 | 1 x 45g | not yet distributed |
| 2324249 | 30-Sep-24 | 1 x 45g | not yet distributed |
| 2324259 | 30-Sep-24 | 1 x 45g | not yet distributed |
| 2324265 | 30-Sep-24 | 1 x 45g | not yet distributed |
Active Pharmaceutical Ingredient: Adapalene 1 mg (0.1%); Benzoyl Peroxide 25 mg (2.5%)
Brief description of the 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the MHRA that the Patient Information Leaflet (PIL) packaged in the above batches of Epiduo 0.1% / 2.5% gel contains outdated safety information regarding pregnancy.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 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. 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 for 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.
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
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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