"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.
ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL
(ES-tra-DYE-ol VAL-er-ate/dye-EN-oh-jest - ES-tra-DYE-ol VAL-er-ate)
COMMON BRAND NAME(S): Natazia
WARNING: Do not use this medication if you smoke and are over 35 years old. Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of blood clots, heart attack, 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). For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.
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 (such as HIV, gonorrhea, chlamydia).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking this medication and each time you get a refill. The leaflet contains very important information on 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 as directed by your doctor, usually once daily. It is very important to continue taking this medication exactly as prescribed. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.
Follow the package instructions to find the first pill, start with the first pill in the pack, and take them 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 12 hours later than the usual time.
Your pill pack contains 28 tablets (enough for 4 weeks). There are 5 different types of tablets in each 28-day pack. Each active tablet contains different amounts of either estradiol alone or a combination of estradiol and dienogest. The last 2 tablets in the pack are reminder pills with no active medication. It is very important to take the tablets in the correct order because the tablets have different amounts of medication.
Take one tablet every day for 28 days in a row. Most women will have their period during the fourth week of the cycle. After you have taken the last tablet in the pack, start a new pack the next day whether or not you have your period. If you do not get your period, consult your doctor.
Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to regularly 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.
If vomiting or severe diarrhea occurs within 3-4 hours of taking a dose or if your dose is more than 12 hours late, your pregnancy risk may be the same as if you had missed a dose. Consult the Patient Information Leaflet for pregnancy risk and need for back-up contraception. 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 (such as patch, other birth control pills, implant), take the first tablet in the pack on the first day of your period. For the first cycle of use only, you need to use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 9 days to prevent pregnancy until the medication has enough time to work.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, other birth control pills, IUD, implant) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
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