Ulipristal

Conditions Treated

Ulipristal is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Ulipristal should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Ulipristal is in a class of medications called progestins. It works by preventing or delaying the release of an egg from the ovary. It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Ulipristal may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Possible Side Effects

What Side Effects Can This Cause?

Ulipristal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• painful menstrual periods
• spotting or bleeding between menstrual periods
• nausea
• tiredness
• headache
• dizziness

Some side effects can be serious. If you experience the following symptom, call your doctor immediately:

• severe lower abdominal pain (3 to 5 weeks after taking ulipristal)

Ulipristal may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Ulipristal comes as a tablet to take by mouth. It is usually taken with or without food as soon as possible after unprotected sexual intercourse. Ulipristal may be taken up to 120 hours (5 days) after unprotected sexual intercourse, but the sooner it is taken, the more likely that it will prevent pregnancy. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ulipristal exactly as directed. Ulipristal may be used at any time during the menstrual cycle. However, it should not be used more than once during the same menstrual cycle. If you vomit less than 3 hours after you take ulipristal, call your doctor. You may need to take another dose of this medication. Because you can become pregnant soon after treatment with ulipristal, you should continue using your regular method of birth control or begin using regular birth control immediately. If you use hormonal contraceptives (birth control pills, implants, patches, rings, or injections), you should also use a barrier method (condom or diaphragm with spermicide) every time you have sex during the same menstrual cycle as you took ulipristal.

What Dietary Instructions Should I Follow

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

Are There Any Special Instructions

Before taking ulipristal, tell your doctor and pharmacist if you are allergic to ulipristal, any other medications, or any of the ingredients in ulipristal tablets. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG), itraconazole (Sporanox), or ketoconazole (Nizoral); barbiturates such as phenobarbital or secobarbital (Seconal); bosentan (Tracleer); certain medications for seizures such as carbamazepine (Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and topiramate (Topamax); and rifampin (Rifadin, Rimactane). Ulipristal may not work as well or may be more likely to cause side effects if it is taken with these medications. tell your doctor what herbal products you are taking, especially St. John's wort. tell your doctor if you have or have ever had any medical conditions and if you are overweight.