MIFEPRISTONE- mifepristone tablet 
GenBioPro, Inc.

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                                                                                 MEDICATION GUIDE
                                                         Mifepristone (MIF-eh-pris-tone) tablets, 200mg for oral use

Read this information carefully before taking Mifepristone tablets, 200mg and misoprostol. It will help you understand how the treatment works. This Medication Guide does not take the place of talking with your healthcare provider.

What is the most important information I should know about Mifepristone tablets, 200mg?
What symptoms should I be concerned with? Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifepristone tablets, 200mg and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider. You can write down your healthcare provider's telephone number here _______________________.

Be sure to contact your healthcare provider promptly if you have any of the following:

If you cannot reach your healthcare provider, go to the nearest hospital emergency room. Take this Medication Guide with you. When you visit an emergency room or a healthcare provider who did not give you your Mifepristone tablets, 200mg, you should give them your Medication Guide so that they understand that you are having a medical abortion with Mifepristone tablets, 200mg.

What to do if you are still pregnant after Mifepristone tablets, 200mg with misoprostol treatment. If you are still pregnant, your healthcare provider will talk with you about a surgical procedure to end your pregnancy. In many cases, this surgical procedure can be done in the office/clinic. The chance of birth defects if the pregnancy is not ended is unknown.

Talk with your healthcare provider. Before you take Mifepristone tablets, 200mg you should read this Medication Guide and you and your healthcare provider should discuss the benefits and risks of your using Mifepristone tablets, 200mg.

What is Mifepristone tablets, 200mg?

Mifepristone tablets, 200mg is used in a regimen with another prescription medicine called misoprostol, to end an early pregnancy. Early pregnancy means it is 70 days (10 weeks) or less since your last menstrual period began. Mifepristone tablets, 200mg is not approved for ending pregnancies that are further along. Mifepristone tablets, 200mg blocks a hormone needed for your pregnancy to continue. When you use Mifepristone tablets, 200mg on Day 1, you also need to take another medicine called misoprostol 24 to 48 hours after you take Mifepristone tablets, 200mg to cause the pregnancy to be passed from your uterus.

The pregnancy is likely to be passed from your uterus within 2 to 24 hours after taking Mifepristone tablets, 200mg and misoprostol. When the pregnancy is passed from the uterus, you will have bleeding and cramping that will likely be heavier than your usual period. About 2 to 7 out of 100 women taking Mifepristone tablets, 200mg will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.

Who should not take Mifepristone tablets, 200mg?

Some women should not take Mifepristone tablets, 200mg. Do not take Mifepristone tablets, 200mg if you:

Ask your healthcare provider if you are not sure about all your medical conditions before taking this medicine to find out if you can take Mifepristone tablets, 200mg.

What should I tell my healthcare provider before taking Mifepristone tablets, 200mg? Before you take Mifepristone tablets, 200mg, tell your healthcare provider if you:

Mifepristone tablets, 200mg and certain other medicines may affect each other if they are used together. This can cause side effects.

How should I take Mifepristone tablets, 200mg?

Follow the instruction below on how to take Mifepristone tablets, 200mg and misoprostol: Mifepristone tablets, 200mg (1 tablet) orally + misoprostol (4 tablets) buccally

Day 1:

24 to 48 hours after taking Mifepristone tablets, 200mg:

mifepristone-str

Follow-up Assessment at Day 7 to 14:

When should I begin birth control?

You can become pregnant again right after your pregnancy ends. If you do not want to become pregnant again, start using birth control as soon as your pregnancy ends or before you start having sexual intercourse again.

What should I avoid while taking Mifepristone tablets, 200mg and misoprostol?

Do not take any other prescription or over-the-counter medicines (including herbal medicines or supplements) at any time during the treatment period without first asking your healthcare provider about them because they may interfere with the treatment. Ask your healthcare provider about what medicines you can take for pain and other side effects.

What are the possible side effects of Mifepristone tablets, 200mg and misoprostol?
Mifepristone tablets, 200mg may cause serious side effects. See “What is the most important information I should know about Mifepristone tablets, 200mg?”

Cramping and bleeding. Cramping and vaginal bleeding are expected with this treatment. Usually, these symptoms mean that the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must follow-up with your healthcare provider approximately 7 to 14 days after taking Mifepristone tablets, 200mg. See “How should I take Mifepristone tablets, 200mg?” for more information on your follow-up assessment. If you are not already bleeding after taking Mifepristone tablets, 200mg you probably will begin to bleed once you take misoprostol, the medicine you take 24 to 48 hours after Mifepristone tablets, 200mg. Bleeding or spotting can be expected for an average of 9 to16 days and may last for up to 30 days. Your bleeding may be similar to, or greater than, a normal heavy period. You may see blood clots and tissue. This is an expected part of passing the pregnancy.

The most common side effects of Mifepristone tablets, 200mg treatment include: nausea, weakness, fever/chills, vomiting, headache, diarrhea and dizziness. Your provider will tell you how to manage any pain or other side effects. These are not all the possible side effects of Mifepristone tablets, 200mg.

Call your healthcare provider for medical advice about any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Mifepristone tablets, 200mg.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Mifepristone tablets, 200mg. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider for information about Mifepristone tablets, 200mg that is written for healthcare professionals. For more information about Mifepristone tablets, 200mg, go to www.MIFEINFO.com or call 1- 855-MIFEINFO (1- 855-643-3463).

Manufactured for:
GenBioPro, Inc.
P.O. Box 32011
Las Vegas, NV 89103
1-855-MIFEINFO (1-855-643-3463)
www.MIFEINFO.com

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 1/2022
GenBioPro, Inc.