Ulipristal (ue-li-PRIS-tal)

Prevents pregnancy. This medicine is an emergency contraceptive pill.

Brand Name(s):

Ella

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take 1 tablet as soon as possible within 5 days (120 hours) after unprotected sex or failure of another birth control method.
• If you vomit within 3 hours of the time you take this medicine, call your doctor right away. Your doctor may prescribe another tablet for you.
• This medicine is only for occasional use as emergency birth control. It should not replace your regular birth control method. This medicine may be taken at any time during your monthly cycle, but do not use this medicine more than 1 time in the same monthly cycle.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the tablet in the blister card inside the original box until you are ready to use it. Do not use it if the package is broken or torn.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how ulipristal works. Tell your doctor if you are using bosentan, carbamazepine, felbamate, griseofulvin, itraconazole, ketoconazole, oxcarbazepine, phenytoin, rifampin, topiramate, St John's wort, or a barbiturate.

Warnings While Using This Medicine:

• Although this medicine is used to prevent pregnancy, you should know that this medicine could harm an unborn baby. If you think you have become pregnant, tell your doctor right away.
• This medicine may make your next monthly period early or late by a few days. If your next period is more than 1 week late, check with your doctor right away for a pregnancy test.
• Tell your doctor if you are breastfeeding or planning to breastfeed.
• Do not use any additional emergency pills (including levonorgestrel) within 5 days after taking this medicine.
• Your regular birth control method including birth control pills, vaginal ring, or patch may not work as well while you are using this medicine. Do not start taking a hormonal contraceptive for at least 5 days after you take this medicine. You must use a barrier method (including a condom with spermicide, diaphragm, or contraceptive foam or jelly) until your next period.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted infections.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Heavy bleeding or cramping
• Severe stomach pain

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild pain with your next period or light spotting before your period starts
• Nausea, mild stomach pain
• Tiredness or dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088