Ulipristal Acetate Oral tablet

What is this medicine?

ULIPRISTAL (UE li pris tal) is an emergency contraceptive. It prevents pregnancy if taken within 5 days (120 hours) after your birth control fails or you have unprotected sex. This medicine will not work if you are already pregnant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to ulipristal, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with or without food. Your doctor may want you to use a quick-response pregnancy test prior to using the tablets. Take your medicine as soon as possible and not more than 5 days (120 hours) after the event. This medicine can be taken at any time during your menstrual cycle. Follow the dose instructions of your health care provider exactly.

Contact your health care provider right away if you vomit within 3 hours of taking your medicine to discuss if you need to take another tablet.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply; this medicine is not for regular use.

What may interact with this medicine?

This medicine may interact with the following medications:

• birth control pills

• bosentan

• certain medicines for fungal infections like griseofulvin, itraconazole, and ketoconazole

• certain medicines for seizures like barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate

• dabigatran

• digoxin

• rifampin

• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your period may begin a few days earlier or later than expected. If your period is more than 7 days late, pregnancy is possible. See your health care provider as soon as you can and get a pregnancy test.

Talk to your healthcare provider before taking this medicine if you know or suspect that you are pregnant. Contact your healthcare provider if you think you may be pregnant and you have taken this medicine. Your healthcare provider may wish to provide information on your pregnancy to help study the safety of this medicine during pregnancy. For information, go to www.ellipse2.com.

If you have severe abdominal pain about 3 to 5 weeks after taking this medicine, you may have a pregnancy outside the womb, which is called an ectopic or tubal pregnancy. Call your health care provider or go to the nearest emergency room right away if you think this is happening.

Discuss birth control options with your health care provider. Emergency birth control is not to be used routinely to prevent pregnancy. It should not be used more than once in the same cycle. Birth control pills may not work properly while you are taking this medicine. Wait at least 5 days after taking this medicine to start or continue other hormone based birth control. Be sure to use a reliable barrier contraceptive method (such as a condom with spermicide) between the time you take this medicine and your next period.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases (STDs).

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• dizziness

• headache

• nausea

• spotting

• stomach pain

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and keep in the blister card inside the original box until you are ready to take it. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.