Valproate is an effective medicine for epilepsy. This medicine can seriously harm an unborn baby. Always use effective contraception during treatment. It is important to visit your specialist to review your treatment at least once each year. Read the package leaflet carefully before using this medication. Never stop valproate without discussing with your doctor first as your condition may become worse. If you are thinking about becoming pregnant, speak to your doctor first. If you become pregnant, talk to your doctor straight away. The patient guide for the pregnancy prevention programme (prevent) can be found here.
WARNING FOR
WOMEN AND
GIRLS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in the product’s package leaflet. This
medicine is subject to additional monitoring. This will
allow quick identification of new safety information.
You can help by reporting any side effects you may get.
See link below for how to report side effects:
more information on the safety of this medicine.
About Dyzantil
Dyzantil Summary of Product Characteristics and Patient Information Leaflets
The links below will take you to the electronic Medicines Compendium (eMC) website.
By using the links below you will leave the Dyzantil website and be re-directed to an external site; Aspire Pharma is not responsible for the content on external websites.
Dyzantil 200mg prolonged-release tablets
Dyzantil 300mg prolonged-release tablets
Dyzantil 500mg prolonged-release tablets
Sodium Valproate Risk Minimisation Materials for Patients
These links will take you to the patient guide and patient card on the electronic Medicines Compendium (eMC) website.
By using the links below you will leave the Dyzantil website and be re-directed to an external site; Aspire Pharma is not responsible for the content on external websites.
Patient GuideSodium Valproate and Pregnancy
We must make you aware of the new regulations introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) around the way in which the drug, sodium valproate, present within Dyzantil® (sodium valproate), is restricted in use in women and girls of childbearing age.1
Sodium valproate is associated with risks for babies exposed to the drug during pregnancy. 11% risk of birth defects in the newborn and a 30-40% risk of neurodevelopmental disorders, which may persist and include autism spectrum disorders. New measures have been designed to ensure that all women who have to take the drug for their epilepsy, are fully informed of the risks, including being advised on the importance of using effective contraception and being invited for a yearly treatment review.1 Should you have any more questions, please discuss this with your doctor or pharmacist for more information.
Women and girls who are at risk of pregnancy must comply with the conditions of the Prevent programme and these include the use of effective contraception and at least annual review of treatment by a specialist. For the Prevent programme or further product information, please refer to the following link: https://www.gov.uk/guidance/valproate-use-by-women-and-girls.
References:
1. Epilepsy Society. Sodium valproate. https://epilepsysociety.org.uk/about-epilepsy/sodium-valproate (accessed February 2024)
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For further information please call: 01730 231148,
email: [email protected] or visit www.aspirepharma.co.uk
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