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Keep up-to-date on Vagifem^® (estradiol vaginal inserts) 10 mcg by signing up to receive information from Novo Nordisk.

Vagifem® is a 10 mcg insert administered directly into the vagina. The Vagifem® applicator is inserted directly into the vagina to administer medicine.

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Important Safety Information

Who should not use Vagifem^®?

Do not start using Vagifem^® if you:

have unusual bleeding

have been diagnosed with a bleeding disorder

currently have or have had certain cancers

had a stroke or heart attack

currently have or have had blood clots

currently have or have had liver problems

are allergic to Vagifem^® or any of the ingredients in it

Before you use Vagifem^®, tell your healthcare provider about all of your medical conditions, including if you:

have any unusual vaginal bleeding

have any other medical conditions that may become worse while you are using Vagifem^®

are going to have surgery or will be on bed rest

are pregnant or think you may be pregnant

are breastfeeding

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Vagifem^®?

Serious but less common side effects include: heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high and low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, high levels of fat (triglyceride) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, cancer changes of endometriosis, enlargement of benign tumors of the uterus (fibroids), worsening of swelling of face and tongue (angioedema) in women with a history of angioedema

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

new breast lumps

unusual vaginal bleeding

changes in vision or speech

sudden new severe headaches

severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

Common side effects of Vagifem^® 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.

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

Talk to your health care provider and find out if Vagifem^® 10 mcg is right for you.