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Ulipristal (ue li PRIS tal)

Adult Medication

Brand Names: U.S.

Ella

Brand Names: Canada

Fibristal

Warning

Ella:

  • This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.

What is this drug used for?

  • It is used to prevent pregnancy.
  • It is used to treat fibroids of the uterus.

What do I need to tell my doctor BEFORE I take this drug?

All products:

  • If you have an allergy to ulipristal or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.

Ella:

  • If you have taken a dose of this drug within the same period (menstrual) cycle.
  • If you are taking any drugs that may make this drug not work as well. This includes bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenobarbital, phenytoin, rifampin, St. John’s wort, and topiramate. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not take this drug if you are breast-feeding.

Fibristal:

  • If you have any of these health problems: Breast cancer, cervical cancer, ovarian cancer, uterine cancer, or vaginal bleeding where the cause is not known.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
  • Do not take St John’s wort with this drug. This drug may not work as well.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • Use birth control that you can trust to prevent pregnancy.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.

Ella:

  • This drug will not end a pregnancy.
  • This drug is not for regular use to prevent pregnancy.
  • If your period is delayed for more than 7 days, talk with your doctor.

Fibristal:

  • Do not take this drug for longer than you were told by your doctor.
  • Most of the time, this drug will lead to less bleeding during monthly periods or no period within 10 days of starting it. The lining of the uterus may also thicken or change while taking this drug. Most of the time, these changes will go back to normal after this drug is stopped. Talk with your doctor.
  • Do not give to a child younger than 18 years of age.
  • A pregnancy test will be done to show that you are NOT pregnant before starting this drug. If you get pregnant while taking this drug, call your doctor right away.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

All products:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Ella:

  • Very bad belly pain.

Fibristal:

  • Vaginal bleeding that is not normal.
  • Groin or pelvic pain or swelling.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

All products:

  • Headache.

Ella:

  • Dizziness.
  • Upset stomach.
  • Belly pain.
  • Feeling tired or weak.
  • Period (menstrual) pain.
  • Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.

Fibristal:

  • Hot flashes.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.

All products:

  • Take with or without food.

Ella:

  • Take this drug within 5 days after unprotected sex.
  • If you throw up within 3 hours of taking this drug, call your doctor.

Fibristal:

  • Take with a full glass of water.
  • Start taking this drug during the first 7 days of your period (menstrual) cycle.

What do I do if I miss a dose?

Ella:

  • Only 1 dose of this drug is needed. If you miss your dose, take it as soon as you think about it.

Fibristal:

  • Take a missed dose as soon as you think about it.
  • If it is almost time for the next dose, skip the missed dose and return to your regular schedule

All products:

  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

Copyright © 2014 Clinical Drug Information, LLC and Lexi-Comp, Inc.