"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.
LEVONORGESTREL/ETHINYL ESTRADIOL NON-CYCLIC CONTRACEPTIVE - ORAL
COMMON BRAND NAME(S): Lybrel
WARNING: Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).
USES: This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.
Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information about when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth once daily or as directed by your doctor. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Pregnancy is more likely if you miss a pill or take a pill late. Make sure you get a new pill pack before you finish your current pack. Also, make sure you have back-up birth control (e.g., condoms) available in case you miss a pill.
If you have been using another form of hormonal birth control (e.g., patch, another type of pill), ask your doctor or pharmacist how to switch to this product.
If you are using this medication for the first time, and you are not switching from another form of hormonal birth control (e.g., patch, ring, other birth control pills), take the first pill in the pack on the first day of your period. If your doctor directs you to start this medication on any other day, use an additional form of birth control for the first 7 days.
Continue taking 1 tablet every day. After taking the last tablet in your old pack, start a new pack the next day. There is no break between packs, and there are no "reminder" tablets (tablets without medication). Most women do not have regular periods while taking this medication. You may have some bleeding or spotting. If this happens, do not stop taking your pills.
If you vomit or have diarrhea within 4 hours after taking this medication, you may need to use a back-up method of birth control. Consult your Patient Information Leaflet for more information. (See also Missed Dose section.)
If you have any stomach upset or nausea with this medication, it may help to take it after your evening meal or at bedtime. You may choose to take this medication at another time of day that is easier for you to remember. No matter what time you choose, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.
Additional Lybrel Information
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