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
• Breastfeeding

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. Be sure to read this information carefully each time. The sheet may change often.

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
• Bosentan
• Carbamazepine
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as griseofulvin, itraconazole, ketoconazole
• Dabigatran
• Digoxin
• Estrogen or progestin hormones
• 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 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.

Talk to your care team about reliable forms of contraception. Emergency contraception is not to be used routinely to prevent pregnancy. It should not be used more than once in the same menstrual cycle. Estrogen and progestin hormones may not work as well while you are taking this medication. Wait at least 5 days after taking this medication to start or continue estrogen or progestin contraceptive medications. Also, a barrier contraceptive, such as a condom or diaphragm, is recommended between the time you take this medication and until your next menstrual period.

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep in the blister card inside the original box until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.