Symptoms

It is difficult to identify which symptoms are specific to the menopausal process and which are specific to the general aging process. The most common—and best-known—symptoms linked to menopause are the vasomotor symptoms (when the blood vessels near the surface of the skin enlarge), specifically hot flashes and night sweats. Approximately two-thirds of women have hot flashes. Because both hot flashes and night sweats can disrupt your ability to get a good night’s sleep, it’s also not uncommon to feel tired, fatigued, or irritable the next day.

Other common complaints reported around menopause include changes in skin (dryness), joint pain, weight gain, and thinning hair. Many women also experience pain during sex (likely due to vaginal dryness) or loss of interest in sex.1

Other symptoms may be reported around menopause but not directly linked to it. These include feeling moody, depressed, or anxious; finding it hard to concentrate; and being forgetful.1

Another important issue is bone loss leading to osteoporosis. It is not a symptom of menopause but rather a consequence of losing estrogen, and it’s something you should be aware of.1

Because menopause encompasses all these symptoms, as well as bone loss, this information is being provided for educational purposes. Please remember that Divigel® is FDA-approved only for the treatment of disruptive, menopausal hot flashes, including night sweats.

You can get more information related to these topics by visiting The North American Menopause Society (www.menopause.org), The American College of Obstetricians and Gynecologists (www.acog.org), and the National Osteoporosis Foundation (www.nof.org).

Symptoms directly linked to menopause1

Hot flashes
Night sweats and resulting sleep disturbances
Vaginal dryness

Common complaints reported around menopause1

Mood swings, depression, anxiety
Lack of concentration, forgetfulness
Skin dryness/loss of elasticity
Joint pain
Weight gain
Thinning hair
Pain during sex/loss of sex drive
Urinary incontinence

Important Safety Information for Patients

The following are not all the possible risks for Divigel®. Please read the full Patient Information leaflet and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients, or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.

In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.

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.

For more information, call 1-800-654-2299.