Ortho Evra Patch - 1 & 2 Month Supply

Drug Name: ORTHO EVRA

IMPORTANT ORTHO EVRA 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 ORTHO EVRA.

ETHINYL ESTRADIOL/NORELGESTROMIN PATCH - TOPICAL (ETH-in-il ess-tra-DYE-ole/nor-el-JESS-troh-min)

COMMON ORTHO EVRA BRAND NAME(S):
Ortho Evra

ORTHO EVRA WARNING:
Smoking cigarettes while using Ortho Evra increases your chance of having heart problems. Do not smoke while using Ortho Evra. 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).

ORTHO EVRA USES:
Ortho Evra combination hormone patch is used to prevent pregnancy. Ortho Evra contains hormones similar to those in birth control pills. The hormones release from the Ortho Evra 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 TAKE ORTHO EVRA:
Review the Ortho Evra 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 Ortho Evra patch. If any of the information is unclear, consult your doctor or pharmacist. Open the Ortho Evra 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 Ortho Evra patch is worn for 7 days. Do not apply the Ortho Evra 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 Ortho Evra patch cycle, even if you still are experiencing some bleeding (still having your period). Do not go longer than 7 days without a Ortho Evra patch. Doing so may make Ortho Evra less effective. If the medication Ortho Evra patch accidentally comes off, is removed, or if it becomes detached, apply a new patch. If Ortho Evra 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 Ortho Evra 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 Ortho Evra Patient Information Leaflet or your doctor or pharmacist.

ORTHO EVRA 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 while taking Ortho Evra, 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.

ORTHO EVRA PRECAUTIONS:
Ortho Evra 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 Ortho Evra patient information leaflet that comes with Ortho Evra for more details. Before having surgery, including dental surgery, tell the doctor(s) that you are using Ortho Evra. 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 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 Ortho Evra patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.

ORTHO EVRA 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. Ortho Evra 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 Ortho Evra or any medicine without doctor or pharmacist approval.

ORTHO EVRA OVERDOSE:
Overdose with Ortho Evra is highly unlikely. If overdose is suspected, remove the patch (or patches) and contact your local poison control center or emergency room immediately. Ortho Evra device may be harmful if swallowed. Symptoms of overdose may include: severe nausea, vomiting, unusual vaginal bleeding or irregular menstrual periods.

ORTHO EVRA NOTES:
Do not allow anyone else to take Ortho Evra. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. A manufacturer's fact sheet about Ortho Evra should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have about Ortho Evra.

MISSED ORTHO EVRA DOSE:
Missed Ortho Evra dose advice differs and depends on the brand used, and the number of doses missed. Refer to the Ortho Evra product package information for advice on missed Ortho Evra doses. Ask your doctor or pharmacist if you have any questions.

ORTHO EVRA STORAGE:
Store Ortho Evra at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store Ortho Evra in the bathroom.