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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRIPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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Important Safety Information
- KAPIDEX may not be right for everyone. You should not take KAPIDEX if you are allergic to KAPIDEX or any of its ingredients. Severe allergic reactions have been reported.
- Symptom relief does not rule out other serious stomach conditions.
- The most common side effects of KAPIDEX were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). KAPIDEX and certain other medicines can affect each other. Before taking KAPIDEX, tell your doctor if you are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, or tacrolimus. If you are taking KAPIDEX with warfarin, you may need to be monitored because serious risks could occur.
Uses of KAPIDEX
- Persistent heartburn two or more days a week, despite treatment and diet changes, could be acid reflux disease (ARD). Prescription KAPIDEX capsules are used in adults to treat heartburn related to ARD, to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and to stop EE from coming back. Individual results may vary. Most damage (erosions) heals in 4–8 weeks.
Talk to your doctor or healthcare professional. Please see full Prescribing Information for KAPIDEX.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
KAPIDEX™ is a trademark of Takeda Pharmaceuticals North America, Inc., and is used under license by Takeda Pharmaceuticals America, Inc.
LPD-00767
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