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INDICATIONS AND USAGE

ESTRACE CREAM (estradiol vaginal cream, USP 0.01%) is a prescription medicine used to treat moderate to severe menopausal changes in and around the vagina.

IMPORTANT RISK INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRACE VAGINAL CREAM (AN ESTROGEN HORMONE)?

Using estrogen alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using ESTRACE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens alone or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).

Using estrogens alone or with progestins may increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.

You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE vaginal cream.

Do not start using ESTRACE if you: have unusual vaginal bleeding, have or had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in ESTRACE vaginal cream, or think you may be pregnant.

Tell your healthcare provider: if you are breastfeeding; about all of your medical problems, your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis (including in women who have had a hysterectomy), lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

ESTRACE vaginal cream should be used at the lowest dose possible for your treatment only as long as needed. Although ESTRACE vaginal cream is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.

The most common side effects include: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and/or bloating, nausea and vomiting, hair loss, fluid retention, vaginal yeast infection, vaginal burning, irritation and itching.

Please see full Prescribing Information, including Boxed Warning and Patient Information.

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INDICATIONS AND USAGE

ESTRACE CREAM (estradiol vaginal cream, USP 0.01%) is a prescription medicine used to treat moderate to severe menopausal changes in and around the vagina.

IMPORTANT RISK INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRACE VAGINAL CREAM (AN ESTROGEN HORMONE)?

Using estrogen alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using ESTRACE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens alone or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).

Using estrogens alone or with progestins may increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.

You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE vaginal cream.

Do not start using ESTRACE if you: have unusual vaginal bleeding, have or had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in ESTRACE vaginal cream, or think you may be pregnant.

Tell your healthcare provider: if you are breastfeeding; about all of your medical problems, your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis (including in women who have had a hysterectomy), lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

ESTRACE vaginal cream should be used at the lowest dose possible for your treatment only as long as needed. Although ESTRACE vaginal cream is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.

The most common side effects include: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and/or bloating, nausea and vomiting, hair loss, fluid retention, vaginal yeast infection, vaginal burning, irritation and itching.

Please see full Prescribing Information, including Boxed Warning and Patient Information.