Valproate (Epilim) – Educational Materials / Toolkit
The HPRA is working with national stakeholders, including patient representatives and healthcare professionals to implement these new and updated risk minimisation measures in Ireland (external website links below), including materials developed to support safe prescribing and dispensing of valproate (Epilim), and in particular to ensure that patients and/or carers are fully informed of the risks and can discuss options with their doctor.
Measures include; Changes to the product information
(Package Leaflet (PL) for patients and Summary of Product Characteristics (SmPC) for healthcare professionals) to reflect these new conditions.
A visual warning to alert healthcare professionals and patients of the risks to the unborn child if used during pregnancy and advising use of effective contraception will appear on the packaging of Epilim medicines.
Educational Materials (guidance booklets and forms), which were already available for patients and doctors, have been updated to reflect the new measures and provide age-appropriate advice. These documents have been disseminated to healthcare professionals in hard copy by the Marketing Authorisation Holder (MAH) (i.e. license holder for the medicine) and are also available to download below. The Educational materials include the following:
A patient alert card, which will be attached to the packaging so that pharmacists can go through it with the patient when valproate (Epilim) is dispensed (the cards will be provided in hard copy while the Epilim product packaging is being updated).