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Important
Safety Information
Serious as well as minor side effects have been reported
with the use of the Patch. Serious risks, which can be life
threatening, include blood clots, stroke and heart attacks and are
increased if you smoke cigarettes. Cigarette smoking
increases the risk of serious cardiovascular side effects,
especially if you are over 35. Women who use the Patch are strongly
advised not to smoke. Some women should not use the Patch,
including women who have blood clots, certain cancers, a history of
heart attack, blood clots, or stroke, as well as those who are or
may be pregnant.
Hormones from ORTHO EVRA get into the blood stream and are
processed by the body differently than hormones from birth control
pills. You will be exposed to about 60% more estrogen if you
use ORTHO EVRA than if you use a typical birth control pill
containing 35 micrograms of estrogen. In general, increased
estrogen may increase the risk of side effects. The risk of venous
thromboembolic events (blood clots in the legs and/or the lungs) may
be increased with ORTHO EVRA use compared with use of birth control
pills. Studies examined the risk of these serious blood clots in
women who used either ORTHO EVRA or birth control pills containing
one of two progestins (levonorgestrel or norgestimate) and 30-35
micrograms of estrogen. Results of these studies ranged from an
approximate doubling of risk of serious blood clots to no increase
in risk in women using ORTHO EVRA compared to women using birth
control pills.
You should discuss with your healthcare professional
whether ORTHO EVRA is a good method of contraception for you. The
Patch does not protect against HIV or sexually transmitted
diseases.
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