For Prescribing Information and FDA-Approved Patient Labeling
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
- Taking estrogen-alone may increase your chance of getting cancer of the uterus
- Taking estrogen-alone may increase your chances of getting strokes or blood
- 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
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
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
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
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
Prescribing Information and FDA-Approved
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