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 Ortho Evra patch increases your chance of having heart problems. Do not smoke while using Ortho Evra patch. 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 Ortho Evra 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 Ortho Evra 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 Ortho Evra patch 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: Ortho Evra patch 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. Ortho Evra patch 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 the Ortho Evra 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.