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. Valproate can cause birth defects and problems with the development and learning of the child if it is taken during pregnancy. The approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) contains detailed warnings and recommendations, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder (see also below). Valproate should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated. The benefits and risks of treatment with valproate should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with valproate plans a pregnancy or if she becomes pregnant. Female patients taking valproate should contact their doctor immediately, if they think they may be pregnant or if they become pregnant. It is important that patients do not stop taking their medication without discussing this with their doctor.
Valproate (Epilim) - Summary of risks and precautions
- Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).
- Valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.
- Valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder.
- Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant.
- You must ensure that all female patients are informed of and understand:
- the risks associated with valproate during pregnancy;
- the need to use effective contraception;
- the need for regular review of treatment;
- the need to rapidly consult her physician if she is planning a pregnancy or becomes pregnant
Valproate (Epilim) - Product information
The approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL))* includes detailed warnings and recommendations for healthcare professionals and patients regarding use of valproate, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder.
*The SmPC and PL are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine. The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side-effects of the medicine concerned. SmPCs for all products currently authorised in Ireland are accessible from the HPRA website (www.hpra.ie). The package leaflet (PL) reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format for patients. The HPRA encourages patients and carers to always read the package leaflet provided with their medicines and to talk to their doctor or another healthcare professional involved in their care, in relation to any concerns they may have.
Copies of the current versions of the product information are available from the HPRA website, under 'Find a Medicine' or see Valproate Product Information page
Valproate (Epilim) Educational Materials / Toolkit
Following approval by the HPRA, educational materials for healthcare professionals and patients have made available by the marketing authorisation holder (MAH i.e. the company that holds the licence for a medicine) as part of the measures developed to provide more detailed information about the risks associated with use of valproate by females of child-bearing potential and during pregnancy.
These educational materials include a patient guide, a patient alert card, a booklet for healthcare professionals, and a checklist for prescribers.
The materials have been developed to support safe prescribing and dispensing of valproate, and in particular to ensure that patients and/or carers are informed of the risks.
Educational materials are available in hard copy from the MAH, or via the links below.
The Health Services Executive (HSE) has also customised documents for use as a local toolkit for prescribers and patients, with these documents accessible from the HSE website