Cufence® 200mg hard capsules storage conditions

Information for patients who have been prescribed Cufence.

Cufence® 200 mg (trientine dihydrochloride 300 mg) is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.²

In May 2021, the European Medicines Agency (EMA) approved an application from Univar Solutions to update the storage conditions for Cufence®¹. As a result the storage conditions changed from

'store in a refrigerator (2°C-8°C), do not freeze'

to

'no special storage conditions' – either before or after opening².

Univar Solutions gained this approval based on newly collected stability data regarding storage of the product outside the 2-8° C temperature range. It needs to be stressed that the formulation of Cufence® has not been changed to enable this change in storage conditions.

The shelf life of the product remains 3 months after first opening and it is advised to keep the bottle tightly closed in order to protect the capsules from moisture³. Do not store Cufence capsules in anything other than the original bottle (e.g. do not store them in a pill box). Do not use the product if the capsules become sticky or wet³.

Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Care Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

If you have any remaining questions, please consult your doctor and the patient information leaflet (https://www.medicines.org.uk/emc/product/11808/pil#about-medicine).

References

1. European Medicines Agency: EMA/410631/2019 – Cufence EPAR Medicines Overview

2. Cufence 200 mg hard capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk) 

https://www.medicines.org.uk/emc/product/11808/smpc#aboutmedicine

3. Cufence 200mg hard capsules – Patient Information leaflet (PIL) -

https://www.medicines.org.uk/emc/product/11808/pil#about-medicine