Uses of Mifepristone Tablets:

• It is used to end a pregnancy.

What do I need to tell my doctor BEFORE I take Mifepristone Tablets?

• If you are allergic to this medicine (mifepristone tablets); any part of this medicine (mifepristone tablets); 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: Adrenal failure, bleeding problems, or porphyrias.
• If you have a pregnancy that is not inside the uterus (ectopic pregnancy).
• If you have an IUD (intrauterine device) in place.
• If you are not able to follow what your doctor tells you for treatment to end your pregnancy or you are not able to get to an ER (emergency room) if you need one.
• If you are more than 10 weeks pregnant.
• If you are not able to learn or follow the Patient-Physician contract.
• If you have a growth in the ovary, fallopian tube, or areas around these parts.
• If you are taking a blood thinner or are on a long-term steroid, such as prednisone.

This is not a list of all drugs or health problems that interact with this medicine (mifepristone tablets).

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 this medicine (mifepristone tablets) 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 Mifepristone Tablets?

• Tell all of your health care providers that you take this medicine (mifepristone tablets). This includes your doctors, nurses, pharmacists, and dentists.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• You can get pregnant again right after your pregnancy ends. If you do not want to get pregnant again, start using birth control that you can trust to prevent pregnancy as soon as your pregnancy ends or before you start having sex again.
• It is normal to have vaginal bleeding or spotting for about 9 to 16 days after using this medicine (mifepristone tablets). Sometimes, this has lasted for up to 30 days. Call your doctor right away if vaginal bleeding continues, if you have heavy vaginal bleeding that does not go away, or if you are worried about your vaginal bleeding.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Mifepristone Tablets) best taken?

Use this medicine (mifepristone tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• You will need to take this medicine (mifepristone tablets) with another drug called misoprostol to pass the pregnancy. Be sure you know when and how to take misoprostol after taking this medicine (mifepristone tablets). Check with you doctor or pharmacist if you have questions.
• Most women will pass the pregnancy within 2 to 24 hours after taking misoprostol. During this time, you will have bleeding and cramping that will most likely be heavier than your normal period. Be sure that you take the misoprostol in a proper place so you are ready. Talk with your doctor.
• Follow up with the doctor as you have been told.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Bleeding a lot (soaking 2 pads per hour).
• Very bad belly pain.
• Severe diarrhea.
• Very bad vaginal irritation.
• Pelvic pain.
• A fast heartbeat.

What are some other side effects of Mifepristone Tablets?

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:

• Feeling dizzy, tired, or weak.
• Headache.
• Stomach pain or diarrhea.
• Upset stomach or throwing up.
• Stomach cramps.
• Vaginal discharge.

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 Mifepristone Tablets?

• If you need to store this medicine (mifepristone tablets) 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (mifepristone tablets) is refilled. If you have any questions about this medicine (mifepristone tablets), please talk with the doctor, 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.