Ulipristal is an emergency contraceptive. It works by stopping or delaying the release of an egg from an ovary. Ulipristal may also make it harder for a fertilized egg to attach to the uterus.

Ulipristal is used to prevent pregnancy after having sex without using a condom or other effective birth control method. Ulipristal is also used to prevent pregnancy after a regular form of birth control has failed. Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.

ULIPRISTAL SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

Ulipristal may also be used for purposes not listed in this medication guide.

Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.

Ulipristal can harm an unborn baby or cause birth defects. Do not use if you are already pregnant or think you might be pregnant.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ulipristal is usually given as soon as possible after unprotected sex or failed birth control method (such as a condom that broke during sex). Follow your doctor's dosing instructions very carefully. Ulipristal can be taken any time during your menstrual cycle, but you must use the medicine within 5 days (120 hours) after unprotected sex.

If you vomit within 3 hours after taking ulipristal, your medication may not be as effective. Call your doctor to discuss the need for taking another ulipristal tablet.

You may take ulipristal with or without food.

After taking ulipristal, you should use a barrier form of birth control (condom or diaphragm with spermicide) at least until your next menstrual period.

You should wait at least 5 days after taking ulipristal before you start using hormonal birth control (birth control pills, injections, implants, skin patches, vaginal rings). Both ulipristal and hormonal birth control may be less effective when used at the same time. You may need to use a barrier form of birth control until your hormonal birth control takes effect.

Store ulipristal in the original container at room temperature, away from moisture, heat, and light.

Contact your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal.

Usual Adult Dose for Contraception:

30 mg orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure

Comments:
-If vomiting occurs within 3 hours, consideration should be given to repeating the dose.
-The drug can be taken at any time during the menstrual cycle.
-This drug is not intended for routine use as a contraceptive.

Use: Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure

You should not use ulipristal if you have already confirmed that you are pregnant, or if you are allergic to ulipristal.

Do not use ulipristal if you have not yet started having menstrual periods, or if you are past menopause.

Tell your doctor if you have ever had:

• an ectopic (tubal) pregnancy; or

• if your last menstrual period was more than 4 weeks ago.

This medicine can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant.

You should not breast-feed while using this medicine.

Since ulipristal is used only once when needed, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Ulipristal will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once or seek emergency medical attention if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Common side effects of ulipristal may include:

• headache;

• dizziness, tired feeling;

• nausea, stomach pain; or

• menstrual pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• birth control pills;

• bosentan;

• griseofulvin;

• St. John's Wort;

• rifampin;

• topiramate;

• a barbiturate--butabarbital, secobarbital, pentobarbital, phenobarbital; or

• seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin.

This list is not complete. Other drugs may affect ulipristal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. Ask your pharmacist any questions you have about ulipristal.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.