Ulipristal

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine 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 or suspected failure of a hormonal contraceptive (such as birth control pills, rings or patches). 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 right after treatment with ulipristal, you should use a barrier method (condom or diaphragm with spermicide) every time you have sex until your next menstrual period. Using hormonal contraceptives within 5 days of taking ulipristal may make both medications less effective. You may begin or resume using hormonal contraceptives at least 5 days after taking ulipristal, but you must continue to also use a barrier method to prevent pregnancy until after you have your next period. If you took ulipristal because of a problem with your hormonal contraceptive, contact your doctor or follow the instructions provided for that specific birth control product.

What SPECIAL PRECAUTIONS should I follow?

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 (Gris-PEG), itraconazole (Onmel, Sporanox), or ketoconazole; barbiturates such as phenobarbital or secobarbital (Seconal); bosentan (Tracleer); certain medications for seizures such as carbamazepine (Equetro, Tegretol, Teril, others), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and topiramate (Topamax, in Qsymia); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Many other medications may also interact with ulipristal, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. 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 are pregnant or think you may be pregnant. Your doctor will probably tell you not to take ulipristal. Do not take ulipristal taken to end an existing pregnancy.

• tell your doctor if you have or have ever had any medical conditions or an ectopic pregnancy (pregnancy outside of the uterus).

• tell your doctor if you are breastfeeding.

• you should know that after you take ulipristal, it is normal for your next menstrual period to begin up to one week earlier or later than expected. If your next menstrual period is delayed for longer than one week after the expected date, call your doctor. You may be pregnant and your doctor will probably tell you to have a pregnancy test.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine 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)
• rash, itching, hives, or swelling of the eyes, face, tongue, throat

Ulipristal may cause other side effects. Call your doctor if you have any unusual problems after you take 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.