ella is an emergency contraceptive. It works by stopping or delaying the release of an egg from an ovary. Ulipristal may also make it harder for a fertilized egg to attach to the uterus.

ella is used to prevent pregnancy after having sex without using a condom or other effective birth control method. It is also used to prevent pregnancy after a regular form of birth control has failed. This medicine is not to be used as a regular form of daily, weekly, or monthly birth control.

ELLA SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

ella is not to be used as a regular form of daily, weekly, or monthly birth control.

ella can harm an unborn baby or cause birth defects. Do not use if you are already pregnant or think you might be pregnant.

Before you take this medicine, tell your doctor if you have a history of ectopic (tubal) pregnancy, or if your last menstrual period was less than 4 weeks ago. Also tell your doctor about all other medicines you use.

Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course. Call your doctor at once if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using this medicine.

Before taking this medicine

You should not use ella if you have already confirmed that you are pregnant, or if you are allergic to ulipristal.

Do not use this medicine if you have not yet started having menstrual periods, or if you are past menopause.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• an ectopic (tubal) pregnancy; or

• if your last menstrual period was more than 4 weeks ago.

This medicine can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant.

Ulipristal can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Take ella exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

ella is usually given as soon as possible after unprotected sex or failed birth control method (such as a condom that broke during sex). Follow your doctor's dosing instructions very carefully. ella can be taken any time during your menstrual cycle, but you must use the medicine within 5 days (120 hours) after unprotected sex.

If you vomit within 3 hours after taking the tablet, your medication may not be as effective. Call your doctor to discuss the need for taking another dose.

You may take this medicine with or without food.

After taking ella, you should use a barrier form of birth control (condom or diaphragm with spermicide) at least until your next menstrual period. Ulipristal can make hormonal contraception less effective. This includes birth control pills, injections, implants, skin patches, and vaginal rings.

You should wait at least 5 days after taking ella before you start using hormonal birth control (birth control pills, injections, implants, skin patches, vaginal rings). Both ulipristal and hormonal birth control may be less effective when used at the same time. You may need to use a barrier form of birth control until your hormonal birth control takes effect

Store in the original container at room temperature, away from moisture, heat, and light.

Contact your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ella.

Usual Adult Dose for Contraception:

One 30 mg tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure

Comments:
-Take with or without food.
-Do not eat grapefruit or drink grapefruit juice during treatment.
-The drug can be taken at any time during the menstrual cycle.

Use: Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure

You should not use ella if you have already confirmed that you are pregnant, or if you are allergic to ulipristal.

Do not use this medicine if you have not yet started having menstrual periods, or if you are past menopause.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• an ectopic (tubal) pregnancy; or

• if your last menstrual period was more than 4 weeks ago.

This medicine can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant.

Ulipristal can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Since this medicine is used only once when needed, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

ella will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have any signs of an allergic reaction ro ella: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once or seek emergency medical attention if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ella.

Common ella side effects may include:

• headache;

• dizziness, tired feeling;

• nausea, stomach pain; or

• menstrual pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine, especially:

• birth control pill;

• bosentan;

• griseofulvin;

• St. John's Wort;

• rifampin;

• topiramate;

• a barbiturate--butabarbital, secobarbital, pentobarbital, phenobarbital; or

• seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin.

This list is not complete. Other drugs may interact with ulipristal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.