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Before taking this medicine You should not be treated with this medicine if you are allergic to prostaglandins, or if you have: • active genital herpes with a vaginal lesion; • placenta previa (the placenta is below the fetus in your uterus); or • if your water has broken. Be sure your doctor knows your entire pregnancy history, especially: • if you have ever had a or major surgery on your uterus; • if you have ever had a baby born in a breech position (not head-first); or • if you have ever had a difficult labor or delivery of a previous child. To make sure dinoprostone is safe for you, tell your doctor if you have ever had: • liver or kidney disease; •; •; • if you are 30 years or older; or • if your pregnancy is at full term (40 weeks). Dinoprostone is not expected to be harmful to the unborn baby when used to induce labor. How is Prostin E2 given? Dinoprostone is a gel or suppository that is placed directly onto the cervix through the vagina using a special applicator. A healthcare provider will give you this medication.

Dinoprostone is usually given while you are lying on your back. Your doctor may use a vaginal speculum to view your cervix. This will help your doctor determine how much of this medication to use. You will need to remain lying down for at least 15 minutes unless your doctor tells you otherwise. Your contractions and your baby's heartbeat will be constantly monitored after you are treated with dinoprostone. Your doctor will also check your cervix frequently to determine how much it has dilated. If your uterus responds to dinoprostone, you may begin having regular uterine contractions within a few hours.

You may also be given other medications to help stimulate your uterine contractions and make them more regular. If your uterus does not respond to dinoprostone within 6 hours, your doctor may apply a second dose. Prostin E2 side effects Get emergency medical help if you have signs of an allergic reaction:; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if your contractions slow down or become uneven, or if you have: • intense pain between contractions; • sudden; • unexpected stomach pain; • chest pain; • easy bruising, unusual bleeding; • bleeding from a wound, surgical incision, or vein where an IV was placed; or • any bleeding that will not stop. Common side effects may include: • slow heartbeats in the baby; •, stomach pain; • feeling of warmth in the vaginal area; •; or • fever. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

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