Patient Guides for Epilim (Valproate) (Men & Women) and Topiramate

New patient information guides have been published containing important information on the anti-seizure medications (Epilim) Sodium Valproate and (Topamax) Topiramate.

The guides have been approved by the Health Products Regulatory Authority (HPRA). They contain new information on the reproductive risks associated with the medications and the latest safety measures that have been put in place. If you are taking either of these medications, please read the information below carefully and download the patient guide that related to you.

I am a Woman taking Sodium Valproate (Epilim)

The guide for women and girls taking EPILIM (Sodium Valproate) is an updated information leaflet on the PREVENT Pregnancy Prevention Programme which was introduced in 2018.

It contains key information about the risks of valproate use during pregnancy and the need for effective contraception. It is important that you read the leaflet even if you have been taking valproate for a while.

Around 11 babies in every 100 born to women who take valproate while pregnant will have a birth defect. This is compared to 2-3 babies in every 100 in the general population. In addition, 30-40% of pre-school children may experience neurodevelopmental disabilities. Please see the patient guide for women and girls, it is of upmost importance that you download and read it.

Other updated materials include:

  • guide for healthcare professionals potentially involved in the care of girls and women of childbearing potential treated with valproate [*new version].
  • An annual risk acknowledgement form, to be used by the specialist with their patient at the start of valproate treatment and during each annual review.
  • patient card is attached to the packaging of valproate to facilitate discussions between the pharmacist and the patient each time valproate is dispensed [*new version]. When broken bulk dispensing cannot be avoided, a copy of the package leaflet should always be provided with a warning sticker added.
  • visual warning to inform healthcare professionals and patients about the risks to an unborn child if used during pregnancy, along with advice to use effective contraception, is displayed on both the inner blister and outer packaging of valproate medicines. See a sample of the outer packaging[*new version] 
  • Pharmacy materials (A4 poster  and shelf barker) to assist pharmacists in dispensing and advising patients taking Epilim. [*new version]
  • Reduced pack size: a pack size of 30 units is now the only available authorised presentation (excluding injections and oral solutions) to mitigate against the need for broken bulk dispensing at the pharmacy level and to ensure that all patients receive a package leaflet and the outer carton with the patient card at each dispensing

I am a man taking Sodium Valproate (Epilim):

The guide for males taking Sodium Valproate is a new guide and is part of the recently introduced precautionary measures which are being taken for male patients on the medication.

A study from 2022 suggested that there may be an increased risk of neurodevelopmental disorders in children born to men being treated with valproate in the 3 months before conception. In this study, around 5 children in every 100 had such disorders when born to fathers treated with valproate, compared to around 3 children in every 100 when born to fathers treated with lamotrigine or levetiracetam (two other anti-seizure medicines).

The European Medicines Agency has recommended a series of precautionary measures which are explained in the new guide.  You can download the new guide here:

Other new materials for males:

Topiramate / Topamax

I am a female taking Topiramate (Topamax)

The guide for women and girls taking Topiramate is a new guide and is part of the recently introduced (October 2023) pregnancy prevention programme associated with the medication.

It contains key information about the risks of topiramate use during pregnancy and the need for effective contraception.

Research has shown that children born to mothers who take topiramate during pregnancy are:

  • 3 times more likely to have certain birth defects.
  • More likely to be smaller and to weigh less than expected.
  • 2 to 3 times more likely to develop autism spectrum disorders, intellectual disabilities, or ADHD compared to the general population.

Because of these risks, the European Medicines Agency recommended a range of new measures to promote patient safety, including a new pregnancy prevention programme. The measures are explained in the guide.

Should you have any concerns, please discuss this with your healthcare professionals as soon as possible.

DO NOT STOP TAKING YOUR MEDICATION WITHOUT CONSULTING WITH YOUR MEDICAL TEAM. 

You can also contact your Epilepsy Ireland Community Resource Officer should you have any queries on these developments. Link: https://www.epilepsy.ie/

The-HPRA-VALPROATE update page.

The HSE: HSE-Valproate-Page

The EMA: www.ema.europa.eu/en/medicines/human/referrals/valproate