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

PRECAUTIONS: Before taking mifepristone, tell your doctor if you are allergic to it; or to misoprostol; or to other progestins (e.g., norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions or other problems. Before using this medicine, consult your doctor if you have any of the following: undiagnosed abdominal growth (adnexal mass), certain adrenal gland problem (chronic adrenal failure), bleeding problem (e.g., coagulopathy), certain blood disorder (inherited porphyrias), IUD (intrauterine birth control device) in place, pregnancy longer than 7 weeks, proven or possible abnormal pregnancy outside the womb (ectopic pregnancy), unable to return for a doctor's visit in 48 hours and again in 14 days, unable to easily get emergency help in the 2 weeks after taking mifepristone.If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood count (anemia), smoking more than 10 cigarettes a day.This drug must be used only if you can easily reach adequate emergency medical services in case you have a serious medical problem.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result.Another pregnancy can occur after this abortion treatment and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Consult your doctor for more information.It is not known whether this drug passes into breast milk. Since the effects of mifepristone on infants are unknown, breast-feeding women should consult their doctors on whether they should discard their breast milk for a few days following this treatment.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: drugs that may increase risk of bleeding (e.g., aspirin, "blood thinners" such as warfarin).If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting mifepristone.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: long-term corticosteroid therapy (e.g., prednisone), drugs affecting liver enzymes that remove mifepristone from your body (e.g., azole antifungals such as itraconazole/ketoconazole, macrolide antibiotics including erythromycin, dexamethasone, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine/phenytoin/phenobarbital).This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.



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