Activella^® 0.5 mg/0.1 mg is used after menopause in women who have a uterus to reduce moderate to severe hot flashes and help reduce your chances of getting osteoporosis (thin weak bones). If you use Activella^® only to prevent osteoporosis, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.

Activella^® 1.0 mg/0.5 mg is also indicated in women who have a uterus for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

		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 Activella^® 1.0 mg/0.5 mg or any of their ingredients, think you may be pregnant, or are breast feeding.

In women with a uterus, the use of estrogen alone may increase the chance of getting cancer of the tissue lining the uterus. Therefore, contact your doctor right away if you have unusual vaginal bleeding.

In clinical trials, the most commonly reported adverse events (reported at a frequency of ≥5%) were back pain, pain in arms and legs, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening, vaginal bleeding, gastroenteritis, insomnia, weight gain, breast pain, uterine fibroid, ovarian cyst, viral infection, fungal infection, and accidental injury.

Estrogens and progestins should be used at the lowest dose possible for your treatment only as long as needed.

Please click here for FDA-Approved Patient Labeling.

Activella^® is only available by prescription. For more information about Activella^®, please call 1-866-668-6336.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

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.

Activella^® is a registered trademark of Novo Nordisk FemCare AG.
© 2011 Novo Nordisk.   0311-00002105-1   May 2011

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