Ulipristal

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.

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

Ulipristal is usually taken as soon as possible after unprotected sex or if a birth control method fails (like a condom that broke during sex). Follow your doctor's dosing instructions very carefully. Ulipristal can be taken at 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 work as well. Call your doctor to discuss whether you need to take another ulipristal tablet.

You can take ulipristal with or without food.

After taking ulipristal, you should use a barrier form of birth control (like a 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 (like birth control pills, injections, implants, skin patches, or 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 starts working.

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 ensure you are not pregnant. Do not take a second course of ulipristal.

Ulipristal is not intended 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.

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

Do not use ulipristal if you have not 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.

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

Call your doctor right away 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, feeling tired;
• 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.

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 failureComments:-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

Since ulipristal is taken 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.

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.

Tell your doctor about all the other medicines you take, 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.