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Important Safety Information for EVAMIST® (estradiol transdermal spray)

What is the most Important Information I should know about EVAMIST (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 EVAMIST. Vaginal bleeding after menopause may be a warning sign of cancer of the womb. Your healthcare provider should check any unusual vaginal bleeding to find the cause.
• Do not use estrogen alone or with progestins to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
• Using estrogen-alone or with progestins may increase your chances of getting strokes, blood clots, or dementia.
• Using estrogens with progestins may increase your chances of getting heart attacks or breast cancer.
• The estrogen in EVAMIST spray can transfer from the area of skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the area of your skin where you sprayed EVAMIST. Young children who are accidentally exposed to estrogen through contact with women using EVAMIST may show signs of puberty that are not expected (for example, breast budding).
• You and your healthcare provider should talk regularly about whether you still need treatment with EVAMIST.

Do not start using EVAMIST if you have unusual vaginal bleeding; 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; have been diagnosed with a bleeding disorder; are allergic to EVAMIST or any of its ingredients; or think you may be pregnant

Before you use EVAMIST, tell your healthcare provider if you have any unusual vaginal bleeding; have any other medical conditions; are going to have surgery or will be on bed rest; are breast feeding

Tell your healthcare provider about all medicines you take. Some medicines may affect how EVAMIST works. EVAMIST may also affect how your other medicines work.

Talk to your healthcare provider about other treatments for your menopause symptoms if accidental exposure to EVAMIST cannot be avoided.

EVAMIST contains alcohol, which is flammable. Avoid fire, flame, or smoking until the area of your skin where you have applied EVAMIST has dried.

The most common side effects associated with EVAMIST are headache, breast tenderness, nipple pain, back pain and nasopharyngitis.

These are not all the possible side effects of EVAMIST. For more information, refer to the Patient Information section of the full Prescribing Information or ask your healthcare provider or pharmacist.