Uses of Dinoprostone Cervical Gel:

• It is used to get your cervix ready for childbirth.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Dinoprostone Cervical Gel?

• If you have an allergy to dinoprostone or any other part of dinoprostone cervical gel.
• If you are allergic to dinoprostone cervical gel; any part of dinoprostone cervical gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Heart disease, kidney disease, liver disease, lung disease, or pelvic inflammatory disease.
• If you have had any of these health problems: A C-section (cesarean section), uterine surgery, unexplained vaginal bleeding during this pregnancy, hard labor, tough delivery, or more than 6 pregnancies that have gone full term or the baby's head did not deliver first.
• If you have genital herpes.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

This is not a list of all drugs or health problems that interact with dinoprostone cervical gel.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dinoprostone cervical gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dinoprostone Cervical Gel?

• Tell all of your health care providers that you take dinoprostone cervical gel. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with dinoprostone cervical gel. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Uterine rupture has happened with some forms of dinoprostone cervical gel. Some people have needed to have their uterus removed. When dinoprostone cervical gel has been used to help with childbirth, uterine rupture has led to loss of the unborn baby or newborn. Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Dinoprostone Cervical Gel) best taken?

Use dinoprostone cervical gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into the vagina or cervix.
• After the gel is put in, lie down for 15 to 30 minutes.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Very bad belly pain.

What are some other side effects of Dinoprostone Cervical Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Diarrhea.
• Headache.
• Fever or chills.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Dinoprostone Cervical Gel?

• If you need to store dinoprostone cervical gel at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about dinoprostone cervical gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.