Important Information for Women Who Could Become Pregnant About the Use of Stavzor (valproic acid) Delayed Release Capsules

Please read this leaflet carefully before you take any of this medication. This leaflet provides a summary of important information about taking this medication to women who could become pregnant. If you have any questions or concerns, or want more information about this medication, contact your doctor or pharmacist.

Information For Women Who Could Become Pregnant

You can only obtain this medication by prescription from your doctor. The decision to use this medicine should be made by you and your doctor based on your health needs and medical condition.

Before starting this medicine, you should know that using this medicine during pregnancy causes an increased chance of birth defects in your baby. These birth defects may include spina bifida and other defects where the spinal canal does not close normally. These defects usually occur in 1 to 2 out of every 1000 babies born in the United States. Studies show that for babies born to epileptic women who took valproate in the first 12 weeks of pregnancy, these defects occur in 1 to 2 out of every 100 babies.

Use of valproate during pregnancy also increases the chance of other birth defects such as of the heart, bones, and other parts of the body. Studies suggest that other medicines used to treat your condition may be less likely to cause these defects.

Information For Women Who Are Planning to Get Pregnant

Women using valproate who plan to get pregnant should discuss their treatment options with their doctor.

Information For Women Who Become Pregnant

If you become pregnant while taking valproate, you should contact your doctor immediately.

Other Important Information

• You should take your medicine exactly as prescribed by your doctor to get the most benefit from your medicine and reduce the risk of side effects.
• If you have take more than the prescribed dose, contact your hospital emergency room or local poison center immediately.
• Your medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

Facts About Birth Defects

It is important to know that birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. This summary provides important information about the use of Stavzor (valproic acid) delayed release capsules to women who could become pregnant. If you would like more information, ask your doctor or pharmacist to let you read the professional labeling and then discuss it with them. If you have any questions or concerns about taking this medication, you should discuss them with your doctor.