Uses of Mifepristone Tablets:

• It is used to lower blood sugar in patients with Cushing's syndrome.

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: Change in the cells lining your uterus, endometrial cancer, or if you have ever had vaginal bleeding where the cause was not known.
• If you do not have Cushing's syndrome.
• If you have any of these health problems: Liver disease or low potassium levels.
• If you are taking a blood thinner or are on a long-term steroid, such as prednisone.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine (mifepristone tablets), like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this medicine (mifepristone tablets).

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.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid grapefruit and grapefruit juice.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also, like a condom, when taking this medicine (mifepristone tablets) and for 1 month after the last dose.
• If you get pregnant while taking this medicine (mifepristone tablets) or within 1 month after your last dose, call your doctor right away.
• 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.

• Take with food.
• Swallow whole. Do not chew, break, or crush.
• If you have trouble swallowing, talk with your doctor.
• Keep taking this medicine (mifepristone tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Vaginal bleeding that is not normal.
• Anxiety.
• Chest pain or pressure.
• Shortness of breath.
• Swelling in the arms or legs.
• Trouble sleeping.
• Low blood sugar can happen. The chance may be raised when this medicine (mifepristone tablets) is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• A type of abnormal heartbeat (prolonged QT interval) can happen with this medicine (mifepristone tablets). Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

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, sleepy, tired, or weak.
• Headache.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Dry mouth.
• Heartburn.
• Back, muscle, or joint pain.
• Nose or throat irritation.

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?

• Store at room temperature in a dry place. Do not store in a bathroom.
• 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.

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.
• 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.