Precautionary measures in male patients

Updated 10 June 2024

Valproate-containing medicines (also known as sodium valproate or valproic acid) are approved in Ireland under the brand name Epilim▼ to treat epilepsy and bipolar disorder.

The European Medicines Agency's safety committee (the PRAC) has recommended precautionary measures for valproate use in male patients. This follows the results from a study to assess the risk of neurodevelopmental disorders (NDDs) in children whose fathers were treated with valproate in the three months before conception.

Further information is available through the links below:

  • A patient guide for male patients, which the prescriber should give to all male patients who begin treatment with valproate or are already undergoing treatment.
  • A guide for healthcare professional guide (see section for ‘Male Patients’) potentially involved in the care of male patients treated with valproate.
  • A patient card, attached to the packaging of valproate to facilitate discussions between the pharmacist and the patient each time valproate is dispensed.
  • The approved product information, which contains the Summary of Product Characteristics (SmPC) for healthcare professionals and the Package Leaflet (PL) for patients, regarding the use of valproate is available here.
  • Direct Healthcare Professional letter – February 2024

Important information

Patients should not stop taking valproate without consulting a doctor.

Male patients who have been prescribed valproate must not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures that could have serious consequences for the patient.

Reporting suspected side effects (adverse reactions)

Valproate–containing medicines are subject to additional monitoring requirements, and healthcare professionals and members of the public are requested to report any suspected adverse reactions associated with their use via the HPRA reporting forms. Any medicine subject to additional monitoring in the EU is identifiable by an inverted black triangle after the medicine's name ▼ and the following explanatory statement in the product information.

▼ This medicinal product is subject to additional monitoring.

Additional information


Direct Healthcare Professional Communication – June 2024

Drug Safety Newsletter Edition 115 – April 2024

Direct Healthcare Professional Communication – February 2024

PRAC Highlights – January 2024


Drug Safety Newsletter Edition 113 – November 2023

Direct Healthcare Professional Communication – September 2023