Generic Name: Mifepristone Tablets (mi FE pris tone)
Brand Name: Mifeprex
- Very bad infections, bleeding, or other problems may rarely happen after any type of abortion. This includes after using this medicine (mifepristone tablets) to end pregnancy. Sometimes, these problems may be deadly.
- Be sure you know who to call and what do if you have an emergency. This includes going to an ER (emergency room) if you cannot reach your doctor. Call your doctor right away if you have a fever that does not go away, very bad belly pain, fast heartbeat, a lot of vaginal bleeding that does not go away, or passing out.
- If this medicine does not cause a full abortion, surgery may be needed. Make sure that you know this medicine (mifepristone tablets), what it is for, how to use it, and when to go back to your doctor. You must agree to the abortion and surgery if needed. You must read the medication guide and sign a patient contract form.
- If you are going to an ER (emergency room) or some other doctor, take the medication guide with you.
- If this medicine does not work in 2 days, your doctor may give you another drug. Call your doctor right away if you have belly pain, weakness, upset stomach or throwing up, or loose stools (diarrhea) more than 24 hours after taking the other drug.
- You may only get this medicine (mifepristone tablets) through a special program. Talk with your doctor.
Uses of Mifepristone Tablets:
- It is used to end a pregnancy.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Mifepristone Tablets?
- If you have an allergy to mifepristone or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are breast-feeding or plan to breast-feed.
- 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 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.
- This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
- 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.
How is this medicine (Mifepristone Tablets) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Follow how to take this medicine (mifepristone tablets) as you have been told by your doctor. Do not use more than you were told to use.
- You will need to take this medicine 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad dizziness or passing out.
- Very bad headache.
- Shortness of breath.
- Feeling very tired or weak.
- A fast heartbeat.
- Very upset stomach or throwing up.
- 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.
- Very loose stools (diarrhea).
- Very bad vaginal irritation.
- Pelvic pain.
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 tired or weak.
- Belly pain.
- Loose stools (diarrhea).
- Upset stomach or throwing up.
- Back pain.
- 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-FDA-1088. You may also report side effects at http://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 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 a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused 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, 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.
This information should not be used to decide whether or not to take this medicine (mifepristone tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (mifepristone tablets). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: December 6, 2017
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