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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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