"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...
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 EXTENDED CYCLE ORAL CONTRACEPTIVE
COMMON BRAND NAME(S): Seasonale
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.
Besides preventing pregnancy, birth control pills have been shown to help make your periods more regular, decrease blood loss and painful periods (dysmenorrhea), and decrease your risk of ovarian cysts.
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.
Begin taking this medication on the first Sunday following the beginning of your period (menstruation). If your period begins on a Sunday, begin taking this medication on that day. The pill pack contains 84 active pills (with hormones) and 7 inactive pills (without hormones). Take one active pill daily for 84 days in a row. The day after you finish all the active pills, start taking one inactive pill daily for 7 days in a row. You should have your period during the week you are taking the inactive pills. The day after you take the last inactive pill, take the first active pill in a new pack to start a new cycle.
It is very important to continue taking this medication exactly as prescribed by your doctor. Take the pills in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
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 dosing schedule you use, 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.
If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (e.g., patch, other birth control pills), use an additional form of non-hormonal birth control (e.g., condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you take all the pills correctly, you will only need to use a back-up method for the first week of the first cycle.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (e.g., patch, other birth control pills) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
Additional Seasonale Information
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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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