Epimax® products – change to recommendations for use

 

In January 2023 Aspire Pharma Limited has issued a Field Safety Notice in relation to three products in the Epimax® range. The affected products are:

• Epimax® Original Cream
• Epimax® Paraffin Free Ointment
• Epimax® Ointment

The company is in the process of updating their product labelling/packaging, due to having received a localised cluster of reports in Scotland, concerning eye-related injuries sustained by patients following the use of these products from the Epimax® range on or around the skin of the eyes. All three products contain cetostearyl alcohol, a known potential skin sensitiser, which is postulated to be the cause of the eye irritation or injuries.

Epimax® Original Cream can be used as a soap substitute when washing in the bath or shower. Epimax® Ointment and Epimax® Paraffin Free Ointment can be used as a soap substitute or a bath additive. All products are topical only products and warnings to avoid contact with the eyes are clearly present on the labels.

Aspire Pharma will update the product labelling to make it clear that the product can be used as a body wash, rather than a soap substitute which could be used around the eyes.  Advice will also be included to rinse the eyes and seek medical advice if the product does accidentally come into contact with the eyes.

Aspire Pharma is in the process of launching Epimax® Eyelid Ointment, which is formulated specifically for use around the eyes, and is currently applying to the Drug Tariff for reimbursement.

Advice for pharmacy teams

• Brief staff on this new information so that they are aware of it when dispensing or selling these products
• Advise any new or existing patients, when dispensing the products, to be aware that the products should only be used as a body wash and the action to take if the product does come into contact with the eyes.