This product is used to end an early pregnancy. It is used up to 63 days after the first day of your last menstrual period. This product contains 2 medications: mifepristone and misoprostol. Mifepristone works by blocking a natural hormone (progesterone) that is needed for the pregnancy to continue. Misoprostol works by making the womb (uterus) contract and the opening of the cervix relax, which causes the contents in the womb to pass out of the body.

Mifepristone and misoprostol must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). In this case, the ectopic pregnancy may suddenly break, resulting in very serious bleeding.

See also Warning section.

Before treatment, your health care professional must make sure your pregnancy is not outside the womb (ectopic), and check how long you have been pregnant.

Read the Patient Information Leaflet provided by your health care professional before you start using this product. If you have any questions, ask your health care professional. Read and sign the consent form and Patient Information Card provided by your health care professional and keep the Patient Information Card with you while using this product and until your health care professional tells you that your treatment was successful.

Take mifepristone by mouth as directed by your health care professional, usually as a single dose. Swallow the mifepristone with a glass of water. After taking mifepristone, wait 24 to 48 hours, then take the misoprostol (as a single dose). To take the misoprostol, place the tablets between your cheeks and gums and allow to dissolve for 30 minutes. If there are still some tablet pieces left in your mouth after 30 minutes, swallow them with a glass of water. Plan to rest for 3 hours after taking the misoprostol tablets. The medications may not work as well if you take misoprostol sooner than 24 hours after taking mifepristone or later than 48 hours after taking mifepristone. Carefully follow your health care professional's directions. Heavy vaginal bleeding does not mean that your treatment was successful. Be sure you know who to call and what to do in case of emergency.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your health care professional says you may do so safely. Grapefruit can increase the chance of side effects with mifepristone. Ask your doctor or pharmacist for more details.

See also Warning section.

Breast tenderness, headache, nausea, vomiting, diarrhea, tiredness, or dizziness may occur. If nausea, vomiting, diarrhea, or weakness last longer than 24 hours after taking the second drug (misoprostol), get medical help right away.

Bleeding and cramping are expected during this treatment. Vaginal bleeding usually starts a few hours after taking the misoprostol. These symptoms usually mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. You must keep all of your follow-up visits so your health care professional can check if your treatment was successful.

Nausea and cramping may get worse in the first 24 hours after you take the second drug (misoprostol). Your health care professional may direct you to take other medication(s) to help with these symptoms. Bleeding and spotting usually last about 11 days and may be much heavier than a normal period. Rarely, this bleeding may need to be stopped by surgery. Get medical help right away 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 worried about heavy bleeding.

Remember that this product has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• fever
• fainting
• fast heartbeat
• severe stomach/abdominal pain or tenderness

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 health care professional.

In the US - Call your health care professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your health care professional for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your health care professional if you are allergic to mifepristone or misoprostol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before using this medication, tell your health care professional your medical history, especially of:

• a certain adrenal gland problem (chronic adrenal failure)
• bleeding/blood problems (such as anemia)
• IUD (intrauterine birth control device)

This product may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your health care professional if you are using marijuana (cannabis).

If you are using an IUD (intrauterine birth control device), it should be removed before using this product.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Another pregnancy can occur after this treatment and before your normal period begins again. If you do not want to get pregnant after ending your pregnancy, you must start using birth control right away. To decrease the chance of birth defects, avoid getting pregnant again before your next menstrual period.

Mifepristone and misoprostol pass into breast milk. Consult your health care professional before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of mifepristone from your body, which may affect how mifepristone works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as erythromycin), dexamethasone, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Mifepristone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine, some statin drugs (such as fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, warfarin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as ultrasound) must be done before you start taking this medication and after taking it. Keep all medical and lab appointments.

You must follow the dosing and appointment schedule as directed by your health care professional. Contact your health care professional right away if you forget to take the dose of misoprostol tablets and it is more than 48 hours after you have taken mifepristone. If you miss an appointment, contact your health care professional right away.

Store at room temperature away from light and moisture. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.