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IMPORTANT
NOTE: The following information is intended
to supplement, not substitute for, the expertise and
judgment of your physician, pharmacist or other healthcare
professional. It should not be construed to indicate
that use of the drug is safe, appropriate, or effective
for you. Consult your healthcare professional before
using this drug.
ETHINYL ESTRADIOL/NORELGESTROMIN
PATCH - TOPICAL (ETH-in-il ess-tra-DYE-ole/nor-el-JESS-troh-min)
COMMON BRAND NAME(S):
Ortho Evra
WARNING: Smoking
cigarettes while using this medication increases your
chance of having heart problems. Do not smoke while
using this medication. The risk of heart problems
increases with age (women greater than 35 years of
age) and with frequent smoking (15 cigarettes per
day or greater).
USES: This combination
hormone patch is used to prevent pregnancy. It contains
hormones similar to those in birth control pills.
The hormones release from the patch slowly over time.
Using this medication patch does not protect you or
your partner against HIV or other sexually transmitted
diseases (STDs).
HOW TO USE: Review
the Patient Information Leaflet. Follow all instructions
on how to use this medication patch and also the best
time (during your menstrual cycle) to start using
the patch. If any of the information is unclear, consult
your doctor or pharmacist. Open the patch container
and apply one patch to an area of clean, dry skin
on the buttock, abdomen, upper outer arm, or upper
body (torso) exactly as directed by your doctor. The
patch is worn for 7 days. Do not apply the patch to
the breast(s), the area around the breast(s); to red,
cut, or irritated skin; or over other topical products
(e.g., make-up, creams, lotions, powders). After 7
days, remove the old patch and apply a new patch.
Repeat this weekly cycle for 3 weeks (3 patches equal
1 cycle). After your third patch is removed, you will
have one week without using the patch. Your menstrual
cycle (period) usually should start during the week
when you do not use the patch. If your menstrual cycle
(period) does not begin during this week, consult
your doctor. After your 4th week, begin a new patch
cycle, even if you still are experiencing some bleeding
(still having your period). Do not go longer than
7 days without a patch. Doing so may make this medication
less effective. If the medication patch accidentally
comes off, is removed, or if it becomes detached,
apply a new patch. If it is detached or comes off
for longer than 24 hours, or if you are not sure how
long the patch has been detached or removed, use additional
forms of birth control (e.g., condoms, spermicide)
for at least 7 days and continue with the same cycle.
After removing each patch, fold the patch in half
so it sticks to itself and discard it in a trash container.
Do not discard or flush the patches down a toilet.
If you weigh more than 198 pounds (90 kg), this patch
may not work as well for you. Make sure your doctor
knows your current weight and ask about which form
of birth control is best for you. If any of this information
is unclear, consult the Patient Information Leaflet
or your doctor or pharmacist.
SIDE EFFECTS: Nausea, vomiting, headache, redness
or itching at the patch application site, dizziness,
breast tenderness, vaginal discomfort/irritation,
or stomach cramping/bloating may occur. If any of
these effects persist or worsen, notify your doctor.
Promptly tell your doctor if any of these side effects
occur: dark patches on the skin (melasma), change
in appetite, weight changes (gain or loss), problem
wearing contact lenses. Tell your doctor immediately
if any of these serious side effects occur: unusual
vaginal discharge, changes in vaginal bleeding (e.g.,
spotting, breakthrough bleeding, prolonged or complete
stoppage of bleeding), swelling, severe headache,
mental/mood changes. Tell your doctor immediately
if any of these unlikely but serious side effects
occur: pain in the groin or lower legs, trouble breathing,
rash, chest pain, stomach pain, vision or eye problems.
Tell your doctor immediately if any of these highly
unlikely but very serious side effects occur: yellowing
eyes or skin, dark urine, one-sided weakness, numbness
in the arms/legs, lumps in the breast. If you notice
other effects not listed above, contact your doctor
or pharmacist.
PRECAUTIONS: This
medication is not recommended for use if you have
the following medical conditions: blood circulation
problems (e.g., history of blood clots in the legs
or groin), history of heart disease or stroke, severe
high blood pressure, diabetes (especially affecting
the circulation), severe headaches, recent major surgery,
long periods of sitting or lying down (e.g., immobility
such as being bedridden), liver problems, history
of yellowing eyes and skin (jaundice) during pregnancy
or while using birth control pills, cancer (especially
endometrial or breast cancer), undiagnosed abnormal
vaginal bleeding, currently pregnant, heavy tobacco
use (if 35 years old or greater). Tell your doctor
your medical history, especially of: high cholesterol
or triglyceride (fat) levels, depression, high blood
pressure, gallbladder problems, thyroid problems,
any allergies. Do not smoke cigarettes. Hormonal birth
control (e.g., pills, injections, devices) products
combined with smoking cigarettes significantly increase
your risk for strokes, blood clots, high blood pressure,
and heart attacks; especially in women older than
35 years of age. Ask your doctor or pharmacist or
consult the patient information leaflet that comes
with this product for more details. Before having
surgery, including dental surgery, tell the doctor(s)
that you are using this product. The drugs in this
patch may cause blotchy, dark areas on your skin (melasma)
and sunlight may intensify this effect. If this occurs,
avoid prolonged sun exposure, use a sunscreen, and
wear protective clothing when outdoors. If you are
near-sighted or wear contact lenses, you may develop
vision problems or may have problems wearing your
contact lenses. Contact your eye doctor if these problems
occur. This medication device must not be used in
pregnancy. If you become pregnant or think you may
be pregnant, inform your doctor immediately. The medication
from this patch passes into breast milk and may have
undesirable effects on the nursing infant. Consult
your doctor before breast-feeding.
DRUG INTERACTIONS: Tell
your doctor of all prescription and nonprescription
medication you may use, especially: anti-seizure medicine
(e.g., carbamazepine, felbamate, phenobarbital, phenytoin,
topiramate), certain antibiotics (e.g., ampicillin,
erythromycin), HIV protease inhibitors (e.g., indinavir,
ritonavir), phenylbutazone, griseofulvin, atorvastatin,
azole antifungals (e.g., itraconazole, ketoconazole),
rifampin, St John's wort, cyclosporine, temazepam,
prednisolone, morphine, theophylline, ascorbic acid
(vitamin C), acetaminophen, aspirin, clofibric acid,
modafinil, troglitazone. This product can affect the
results of certain lab tests (e.g., blood tests such
as glucose, clotting factors, or thyroid). Make sure
laboratory personnel and your doctors know you use
this product. Do not start or stop any medicine without
doctor or pharmacist approval.
OVERDOSE: Overdose
with this product is highly unlikely. If overdose
is suspected, remove the patch (or patches) and contact
your local poison control center or emergency room
immediately. This medicine device may be harmful if
swallowed. Symptoms of overdose may include: severe
nausea, vomiting, unusual vaginal bleeding or irregular
menstrual periods.
NOTES: Do not share
this medication patch with others. Keep all appointments
with your doctor and when having laboratory tests
performed. You should have a complete physical exam
including blood pressure, breast exams, pelvic exams,
and PAP smears at least once a year.
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