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ACTIVELLA® 0.5 mg/0.1 mg and ACTIVELLA® 1.0 mg/0.5 mg is used after menopause to reduce moderate to severe hot flashes and help reduce your chances of getting osteoporosis (thin weak bones).
ACTIVELLA® 1.0 mg/0.5 mg is also used after menopause to treat moderate to severe dryness, itching, and burning in or around the vagina.
Important Safety Information
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ACTIVELLA® (a combination of estrogen and progestin hormones)?
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 chance of getting heart attacks, strokes, breast cancer, and blood clots.
Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia.
You and your health care provider should talk regularly about whether you still need treatment with ACTIVELLA®.
Do not take ACTIVELLA® if you have had your uterus removed (hysterectomy). Do not start taking ACTIVELLA® 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 past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to ACTIVELLA® 0.5 mg/0.1 mg or any of its ingredients, think you may be pregnant, or are breast feeding.
In a clinical trial, the most commonly reported adverse events (reported at a frequency of ≥5%) were pain, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening and bleeding.
Estrogens and progestins should be used at the lowest dose possible for your treatment only as long as needed.
