"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ULIPRISTAL - ORAL
COMMON BRAND NAME(S): Ella
USES: This medication is used by women to prevent pregnancy after unprotected sex or birth control failure (such as a broken condom). This medication is an emergency contraceptive and should not be used as a regular form of birth control. It prevents pregnancy by preventing the release of an egg (ovulation) and changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or attach to the wall of the womb (implantation).
Using this medication will not stop an existing pregnancy or protect you against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
HOW TO USE: Take 1 tablet by mouth, with or without food, as soon as possible after unprotected sex. This medication works best when it is taken within 120 hours (5 days) after unprotected sex. Take the medication exactly as prescribed by your doctor.
If you vomit within 3 hours of taking this medication, contact your doctor to discuss whether you need to repeat the dose.
The amount and timing of your period may be irregular after taking this medication. Tell your doctor immediately if your period is more than 7 days late. You may need to take a pregnancy test.
Because you can become pregnant soon after treatment with ulipristal, you should continue using your regular method of birth control immediately. Ulipristal may make other hormonal birth control less effective. Using a barrier-type birth control (such as condoms, diaphragm) is recommended every time you have sex during the same menstrual cycle that you took ulipristal.
Additional Ella Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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