Ortho Evra®
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.
