Ortho EvraŽ is a safe, effective and easy-to-use
birth control patch for women. It is the first
birth control patch approved by the U.S. FDA,
and the first weekly form of birth control that
is as effective as the Pill. Ortho EvraŽ is a
small, thin patch, designed to be worn under your
clothes; it's easy to wear, and is more than 99%
effective when used correctly.
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Ortho EvraŽ
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.
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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