"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: Ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg.
Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
This medication may not work well in women who are overweight (for example, body mass index greater than 30). Talk to your doctor for more details and to see if this medication is right for you.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking ulipristal. If you have any questions, ask your doctor or pharmacist.
Take 1 tablet by mouth with or without food as directed by your doctor as soon as possible after unprotected sex. This medication works best when it is taken within 120 hours (5 days) after unprotected sex.
If you vomit within 3 hours of taking this medication, contact your doctor to ask if you need to repeat the dose.
After you take this medication, the time when your period comes and how much you bleed may change. Tell your doctor right away if your period is more than 7 days late. You may need to take a pregnancy test.
After using this medication, you should use a barrier-type birth control (such as condoms, diaphragm) every time you have sex until you have your period. If you use or wish to use hormonal birth control, wait at least 5 days after using this medication before starting hormonal birth control (since these medications may interact and make both drugs work less well). Continue using a barrier-type birth control until your hormonal birth control takes effect. If needed, talk to your doctor about reliable forms of birth control.
Additional Ella Information
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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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