Important
Safety Information
Estrasorb is indicated for the treatment of
moderate to severe vasomotor symptoms associated with menopause. Estrasorb should
not be used in women with any of the following conditions:
undiagnosed abnormal genital bleeding; known, suspected, or
history of cancer of the breast; known or suspected estrogen-dependent
neoplasia; active deep-vein thrombosis, pulmonary embolism
or history of these conditions; active or recent (eg, within
the past year) arterial thromboembolic disease (eg, stroke,
myocardial infarction); liver dysfunction or disease. Estrasorb should not be used in patients with known hypersensitivity
to its ingredients; known or suspected pregnancy. There is
no indication for Estrasorb in pregnancy. There appears
to be little or no increased risk of birth defects in women
who have used estrogens and progestins from oral contraceptives
inadvertently during early pregnancy (See PRECAUTIONS in full
Prescribing Information).
The most frequently reported adverse events (≥5% and more frequently
than placebo) in clinical trials for Estrasorb were: Infection; Sinusitis;
Pruritus; Breast pain; and Endometrial disorder. |
Important
safety information you should know about estrogen.
Estrogens increase the chances of getting
cancer of the uterus. Report any unusual vaginal
bleeding right away while you are using Estrasorb.
Vaginal bleeding after menopause may be a warning
sign of cancer of the uterus (womb). Your healthcare
professional should check any unusual vaginal bleeding
to find out the cause.
Do not use estrogens with or without progestins to prevent heart
disease, heart attacks, strokes, or dementia.
Using estrogens with or without progestins may increase your
chances of getting heart attacks, strokes, breast cancer, and
blood clots. Using estrogens with or without progestins may increase
your risk of dementia, based on a study of women aged 65 years
or older. You and your healthcare professional should talk regularly
about whether you still need treatment with Estrasorb. |
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