Ulipristal is used to treat fibroids in the uterus by women of childbearing age who are eligible for surgery. This medication is different from the hormone (such as progestin) that your body normally makes. Ulipristal works by acting like a type of progestin (such as progesterone). Ulipristal belongs to a class of drugs known as selective progesterone receptor modulators or SPRMs. It helps to reduce pain/discomfort and heavy menstrual bleeding caused by uterine fibroids.

This product has been withdrawn from the Canadian market due to problems with safety.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be prescribed as an emergency contraceptive after unprotected sex or birth control failure (such as a broken condom). Do not use it as a regular form of birth control.

Read the Patient Information Leaflet if available from your pharmacist before you start taking ulipristal and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Your doctor may direct you to start this medication during the first 7 days of your menstrual period. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition lasts or gets worse.

Headache, hot flashes, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

When this medication is used regularly, it is expected that your menstrual period will stop (or decrease to light bleeding/spotting) usually within the first 10 days of treatment. Menstrual periods usually return within 4 weeks after treatment is stopped. If bleeding lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Ulipristal may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

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 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 or at www.fda.gov/medwatch.

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

Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• cancer (especially breast, cervical, ovarian, or uterine cancer)
• unexplained vaginal bleeding
• asthma
• liver disease

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

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

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable non-hormonal forms of birth control (such as condoms, diaphragm with spermicide) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. See also Drug Interactions section.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• levonorgestrel
• progesterone containing products

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

This medication may decrease the effectiveness of certain hormonal birth control such as pills, patch, ring or intrauterine device. This could cause pregnancy. Discuss with your doctor or pharmacist of other reliable birth control methods you can use while using this medication.

This medication may interfere with certain lab tests (such as endometrial biopsy), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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.

Do not share this medication with others.

A pregnancy test may be performed before you start treatment.

Lab tests (such as liver function) should be done before you start taking this medication, during treatment, and after you stop taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. 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.