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.
Capitalized product names are
registered trademarks of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
This information is intended for use by our customers,
patients and healthcare professionals in the United States only. Ortho
Women's Health & Urology™, Division of Ortho-McNeil-Janssen
Pharmaceuticals recognizes that the Internet is a global communications
medium; however, laws, regulatory requirements and medical practices
for pharmaceutical products vary from country to country. The
prescribing information included here may not be appropriate for use
outside the United States.
