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February 10, 2012
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mifepristone - oral, Mifeprex (cont.)

HOW TO USE: Read the Medication Guide provided by your doctor before you start using mifepristone. Keep the guide to reread if needed. If you have any questions, consult your doctor or pharmacist. Read and sign the Patient Agreement form provided by your doctor. Tell your doctor if you do not understand how to use this medication or cannot follow the instructions. Mifepristone is available only from your doctor. It is not available from store pharmacies.You must visit the doctor's office 3 times (days 1, 3, and 14) to complete your treatment and important examinations. This treatment is only given under direct medical supervision in a doctor's office, clinic, or hospital. Be sure to have clear instructions from your doctor regarding whom to call and what to do in case of an emergency.Your doctor may want to do an ultrasound to make sure your pregnancy is less than 7 weeks and is not outside the womb (ectopic).Mifepristone is taken by mouth as a single dose or as directed by your doctor. Return to your doctor's office 2 days later. At that time, if a complete abortion is not confirmed by exam or ultrasound, you will take another medication (misoprostol) by mouth as a single dose. It is very important that you take the misoprostol no more than 48 hours after you take the mifepristone. Heavy vaginal bleeding does not mean that an abortion is complete.Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise.It is important that you return for a follow-up visit 14 days after taking mifepristone, even if you are not having any problems.If abortion does not occur or is not complete, or there are serious medical problems, surgery may be needed. If the treatment fails and the pregnancy continues until birth, there is a risk of birth defects.

SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, weakness, or dizziness may occur. If these effects persist longer than the first 24 hours after taking the second drug (misoprostol), seek immediate medical attention because they can be signs of a serious medical problem.Bleeding and cramping are expected during this treatment. Usually, the symptoms mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. Therefore, you must return for all 3 of your doctor visits. Nausea and cramping may worsen in the 24 hours after you take the second drug (misoprostol). Your doctor may direct you to take other medication to help with these symptoms. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Bleeding and spotting may last up to 30 days and may be much heavier than a normal period. In very few cases, this bleeding will need to be stopped by surgery. Seek immediate medical attention if you bleed enough to soak through 2 thick, full-size sanitary pads each hour for 2 hours in a row, or if you are concerned about heavy bleeding.Remember that your doctor has prescribed this medication because he or she 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.Seek immediate medical attention if you have any of these unlikely but very serious side effects: fever of 100.4 degrees F (38 degrees C) or higher, fainting, fast heartbeat, stomach/abdominal pain or tenderness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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