This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used by women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

This drug is inserted high in your vagina next to the cervix by a health care professional. You will be lying on your back with your knees bent outward while the medication is placed, and you will usually need to continue lying down for at least 15 to 30 minutes to prevent the gel from leaking out. The health care professional will tell you when you can get up and walk around.

This medication should only be used in a hospital setting with trained medical care available. You will be monitored for changes in your cervix, for signs of active labor (such as water breaking, strong sustained contractions), and for your baby's condition. If you do not have signs of active labor after 6 hours, your doctor may give you another dose. The dosage is based on your medical condition and response to treatment.

Side effects such as fever, nausea, vomiting, diarrhea, or abdominal pain are uncommon and usually mild. If any of these effects last or get worse, tell your doctor or midwife right away.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• strong contractions that are very close together (uterine overstimulation)

Get medical help right away if you have any very serious side effects, including:

• easy bruising/bleeding
• shortness of breath
• chest pain
• confusion

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Symptoms include severe pain in your womb and an abnormal heart rate in your baby. Careful monitoring by your doctor or midwife may decrease your risk.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dinoprostone, tell your doctor, midwife, or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor your medical history, especially of:

• asthma
• full-term births including previous cesarean section (c-section) births
• glaucoma
• infections in the vaginal area (such as genital herpes)
• vaginal bleeding during pregnancy
• surgery on the cervix/womb
• womb scarring

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug should not be used if you are carrying more than one baby, if your labor has already started, or if your water has broken.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other prostaglandins (such as misoprostol)
• oxytocin

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Use under direct medical supervision.

Not applicable.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.