Ulipristal oral tablets

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 regular birth control fails or you have unprotected sex. This medicine will not work if you are already pregnant.

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.

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 to your doctor or health care professional if they continue or are bothersome):

• abdominal pain or cramping

• dizziness

• headache

• nausea

• spotting

• tiredness

What may interact with this medicine?

This medicine may interact with the following medications:

• barbiturates such as phenobarbital or primidone

• birth control pills

• bosentan

• carbamazepine

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

• certain medicines for HIV or AIDS or hepatitis

• dabigatran

• digoxin

• felbamate

• fexofenadine

• oxcarbazepine

• phenytoin

• rifampin

• St. John's Wort

• topiramate

What if I miss a dose?

This medicine is not for regular use. If you vomit within 3 hours of taking your dose, contact your health care professional for instructions.

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.

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

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

• liver disease

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

• pregnant or trying to get pregnant

• breast-feeding

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.

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).