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Ulipristal

Generic Name: ulipristal (UE-li-PRIS-tal)
Brand Name: ella

Ulipristal is used for:

Preventing pregnancy after unprotected sexual intercourse or known or suspected birth control failure.

Ulipristal is a progesterone agonist/antagonist. Exactly how it works is not known. It may prevent pregnancy by stopping or delaying ovulation or altering the lining of the uterus to prevent implantation if fertilization occurs.

Do NOT use ulipristal if:

  • you are allergic to any ingredient in ulipristal
  • you know or suspect that you are pregnant
  • you have already taken ulipristal during your current menstrual cycle
  • you have been through menopause
  • you are taking any medicines that may decrease ulipristal's effectiveness (eg, barbiturates [eg, phenobarbital], bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate). There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using ulipristal:

Some medical conditions may interact with ulipristal. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of ectopic pregnancy (pregnancy outside of the uterus), or you have not had your first menstrual period
  • if you are overweight

Some MEDICINES MAY INTERACT with ulipristal. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole) because they may increase the risk of ulipristal's side effects
  • Barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, efavirenz, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, primidone, rifamycins (eg, rifabutin, rifampin, rifapentine), St. John's wort, or topiramate because they may decrease ulipristal's effectiveness
  • Dabigatran or digoxin because the risk of their side effects may be increased by ulipristal.
  • Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by ulipristal

This may not be a complete list of all interactions that may occur. Ask your health care provider if ulipristal may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ulipristal:

Use ulipristal as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ulipristal. Talk to your pharmacist if you have questions about this information.
  • Take ulipristal by mouth with or without food.
  • Keep ulipristal in its original packaging until you are ready to take it. Do not take it if the package is torn or broken.
  • Take ulipristal as soon as possible after known or suspected birth control failure or after you have unprotected sexual intercourse. The dose must be taken within 120 hours (5 days), or as directed by your doctor.
  • Ulipristal can be used any time during the menstrual cycle.
  • If vomiting occurs within 3 hours after taking ulipristal, talk with your health care provider to discuss whether to repeat that dose.
  • If you are unsure about your general health or pregnancy status, a follow-up physical or pelvic exam may be needed after taking ulipristal.
  • If you miss a dose of ulipristal, contact your doctor right away.

Ask your health care provider any questions you may have about how to use ulipristal.

Important safety information:

  • Ulipristal may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use ulipristal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Ulipristal is an emergency contraceptive. It should not be used for routine birth control. Ulipristal may reduce the effectiveness of hormonal contraceptives (eg, birth control pills). If you have sexual intercourse after you take ulipristal but before you have your next menstrual period, be sure to use an effective barrier form of contraception, such as a diaphragm or condom.
  • You should not take ulipristal more than once within the same menstrual cycle; safety and effectiveness with repeated use within the same menstrual cycle have not been confirmed. Contact your doctor if you have questions about this information.
  • Seek immediate medical attention if you experience severe lower stomach pain about 3 to 5 weeks after you take ulipristal. This may be a symptom of an ectopic pregnancy (pregnancy outside of the uterus).
  • After taking ulipristal, your normal menstrual cycle may begin a few days earlier or later than usual. Contact your doctor if your menstrual period is delayed for longer than 7 days after you expected it to occur.
  • Ulipristal does not protect against HIV infection and other sexually transmitted diseases.
  • Before you take ulipristal, a pregnancy test may be performed. It is important to determine that you are not pregnant before you take ulipristal. Discuss any questions or concerns with your doctor.
  • Ulipristal should not be used in CHILDREN younger than 18 years old who have not started having a menstrual cycle; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Ulipristal will not end an existing pregnancy. Do not use ulipristal if you are pregnant. If you find out you are pregnant after taking ulipristal, contact your doctor. You will need to discuss the risks of using ulipristal while you are pregnant. Ulipristal is found in breast milk. Do not take ulipristal if you are breast-feeding.

Possible side effects of ulipristal:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in menstrual flow or duration; dizziness; headache; nausea; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); missed menstrual period; pain during menstrual period; spotting instead of your usual period.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ulipristal:

Store ulipristal between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ulipristal out of the reach of children and away from pets.

General information:

  • If you have any questions about ulipristal, please talk with your doctor, pharmacist, or other health care provider.
  • Ulipristal is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ulipristal or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ulipristal. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ulipristal. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ulipristal.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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