Ulipristal Tablets

What is this medication?

ULIPRISTAL (UE li pris tal) can prevent pregnancy. It should be taken as soon as possible in the 5 days (120 hours) after unprotected sex or if you think your contraceptive didn't work. It belongs to a group of medications called emergency contraceptives. It does not prevent HIV or other sexually transmitted infections (STIs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ella

What should I tell my care team before I take this medication?

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

• Liver disease
• An unusual or allergic reaction to ulipristal, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with or without food. Your care team may want you to use a quick-response pregnancy test prior to using the tablets. Take your medication as soon as possible and not more than 5 days (120 hours) after the event. This medication can be taken at any time during your menstrual cycle. Follow the dose instructions of your care team exactly.

Contact your care team right away if you vomit within 3 hours of taking your medication 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 care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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

What may interact with this medication?

This medication may interact with the following:

• Barbiturates such as phenobarbital or primidone
• Birth control pills
• Bosentan
• Carbamazepine
• Certain medications for fungal infections like griseofulvin, itraconazole, and ketoconazole
• Certain medications for HIV or AIDS or hepatitis
• Dabigatran
• Digoxin
• Felbamate
• Fexofenadine
• Oxcarbazepine
• Phenytoin
• Rifampin
• St. John's Wort
• Topiramate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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 care team as soon as you can and get a pregnancy test.

Talk to your care team before taking this medication if you know or suspect that you are pregnant. Contact your care team if you think you may be pregnant and you have taken this medication.

If you have severe abdominal pain about 3 to 5 weeks after taking this medication, you may have a pregnancy outside the womb, which is called an ectopic or tubal pregnancy. Call your care team or go to the nearest emergency room right away if you think this is happening.

Discuss birth control options with your care team. 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 medication. Wait at least 5 days after taking this medication 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 medication and your next period.

This medication does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases (STDs).

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Fatigue
• Headache
• Irregular menstrual cycles or spotting
• Menstrual cramps
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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 medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.