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For Prescribing Information and FDA-Approved Patient Labeling click here

Indications and Usage:

Activella® (estradiol/norethindrone acetate) tablets are used after menopause to reduce moderate to severe hot flushes, treat moderate to severe menopausal changes in and around the vagina, and help reduce your chances of getting osteoporosis (thin weak bones).

If you use Activella® 1.0 mg/0.5 mg only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

If you use Activella® only to prevent osteoporosis that may occur after menopause, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.

Important Safety Information:

What is the most important information I should know about Activella® (a combination of estrogen and progestin)?

  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Taking estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Taking estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
  • Taking estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Taking estrogen-alone may increase your chances of getting strokes or blood clots.
  • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with Activella®.

Do not take Activella® if you have had your uterus (womb) removed (hysterectomy); have unusual vaginal bleeding; currently have or have had certain cancers (including cancer of the breast or uterus); had a stroke or heart attack; currently have or have had blood clots; currently have or have had liver problems; have been diagnosed with a bleeding disorder; are allergic to Activella® or any of its ingredients; or think you may be pregnant.

Before you take Activella®, tell your healthcare provided if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.

Possible less serious, but common side effects of Activella® include headache, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

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.

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.

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

Activella® is a registered trademark of Novo Nordisk FemCare AG.
© 2014 Novo Nordisk  All rights reserved.  1113-00019236-1   January 2014

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