For the treatment of moderate-to-severe vasomotor symptoms due to menopause
Full Prescribing Information

What menopause symptoms might I experience?

Menopause isn’t a sudden change. It’s a transition that takes place over time. In fact, you might experience symptoms for years before your final menstrual period, as the levels of ovarian hormones in your body continue to change. These estrogen levels decline in an uneven fashion, and can sometimes actually be higher than when you were younger.1

The lowered levels of estrogen and progesterone that bring on menopause can also cause symptoms including irregular periods and hot flashes.1 Some women will experience few or mild menopause symptoms, while others may find their symptoms to be uncomfortable and even unbearable, even though they are perfectly normal. Common signs of menopause include:2,3

  • Changes in your menstrual cycle

    About 90% of women go through between four and eight years of cycle changes before periods stop.
  • Vasomotor Symptoms (Hot Flashes, flushes and night sweats)

    Thought to be a possible result of changes in the hypothalamus, the part of the brain that regulates body temperature, hot flashes can cause flushing in the face and neck, an uncomfortable feeling of warmth, sweating and chills, and even increased heart rate. Night sweats occur when hot flashes happen at night and cause heavy perspiration.
  • Trouble sleeping

    Around the time of menopause, some women experience sleep disturbances.
  • Vaginal dryness

    Decreases in estrogen levels may cause thinning and drying of the tissues of the vulva and the lining of the vagina, a condition known as atrophy. Vaginal secretions can also diminish. These factors can make sexual intercourse uncomfortable or painful.
  • Mood swings and anxiety

    Women undergoing perimenopause may experience these symptoms, along with feelings of depression. Also, as many as 43% of women complain of loss of energy during the menopause transition, and for two years postmenopause.2
  • Osteoporosis

    This condition, in which your bones get thin and weak, can lead to loss of height and broken bones.
  • Changing feelings about sex

    Some women feel less aroused or interested, perhaps because sex is more physically uncomfortable. However, other women feel more in touch with their sexuality after menopause.
  • Other changes

    These changes can range from forgetfulness to weight gain to joint pain. Experts have not concluded whether these kinds of changes are a result of menopause, or of aging

Evamist is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Evamist is not indicated for the treatment of other menopause symptoms.

References:

  1. G Ellis. Understanding what happens in menopause. Philadelphia Tribune, February 24, 2015:8A.
  2. The North American Menopause Society. The Menopause Guidebook, Seventh Edition. 2012. pp. 5-19.
  3. The National Women’s Health Information Center. Understanding menopause. Available at: http://www.womenshealth.gov/menopause/menopause-basics/index.html#c. Accessed July 20, 2015.
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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 s 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.