Change Font Size ORTHO TRI-CYCLEN DRUG INFO

IMPORTANT NOTE: Thefollowing information is intended to supplement, not substitute for,the expertise and judgment of your physician, pharmacist or otherhealthcare professional. It should not be construed to indicate thatuse of the drug is safe,appropriate, or effective for you. Consult yourhealthcareprofessional 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 this medication increases your chance ofhaving heart problems. Do not smoke while using this medication. Therisk of heart problems increases with age (women greater than 35 yearsof age) and with frequent smoking (15 cigarettes per day or greater).

USES:This combination hormone patch is used to prevent pregnancy. Itcontains hormones similar to those in birth control pills. The hormonesrelease from the patch slowly over time. Using this medication patchdoes not protect you or your partner against HIV or other sexuallytransmitted diseases (STDs).

HOW TO USE: Review thePatient Information Leaflet. Follow all instructions on how to use thismedication patch and also the best time (during your menstrual cycle)to start using the patch. If any of the information is unclear, consultyour doctor or pharmacist. Open the patch container and apply one patchto 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 isworn for 7 days. Do not apply the patch to the breast(s), the areaaround the breast(s); to red, cut, or irritated skin; or over othertopical products (e.g., make-up, creams, lotions, powders). After 7days, remove the old patch and apply a new patch. Repeat this weeklycycle for 3 weeks (3 patches equal 1 cycle). After your third patch isremoved, you will have one week without using the patch. Your menstrualcycle (period) usually should start during the week when you do not usethe patch. If your menstrual cycle (period) does not begin during thisweek, consult your doctor. After your 4th week, begin a new patchcycle, even if you still are experiencing some bleeding (still havingyour period). Do not go longer than 7 days without a patch. Doing somay make this medication less effective. If the medication patchaccidentally comes off, is removed, or if it becomes detached, apply anew patch. If it is detached or comes off for longer than 24 hours, orif you are not sure how long the patch has been detached or removed,use additional forms of birth control (e.g., condoms, spermicide) forat least 7 days and continue with the same cycle. After removing eachpatch, fold the patch in half so it sticks to itself and discard it ina 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 aswell for you. Make sure your doctor knows your current weight and askabout which form of birth control is best for you. If any of thisinformation is unclear, consult the Patient Information Leaflet or yourdoctor or pharmacist.

SIDE EFFECTS: Nausea, vomiting,headache, redness or itching at the patch application site, dizziness,breast tenderness, vaginal discomfort/irritation, or stomachcramping/bloating may occur. If any of these effects persist or worsen,notify your doctor. Promptly tell your doctor if any of these sideeffects occur: dark patches on the skin (melasma), change in appetite,weight changes (gain or loss), problem wearing contact lenses. Tellyour 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 doctorimmediately 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 ifany of these highly unlikely but very serious side effects occur:yellowing eyes or skin, dark urine, one-sided weakness, numbness in thearms/legs, lumps in the breast. If you notice other effects not listedabove, contact your doctor or pharmacist.

PRECAUTIONS:This medication is not recommended for use if you have the followingmedical conditions: blood circulation problems (e.g., history of bloodclots in the legs or groin), history of heart disease or stroke, severehigh blood pressure, diabetes (especially affecting the circulation),severe headaches, recent major surgery, long periods of sitting orlying down (e.g., immobility such as being bedridden), liver problems,history of yellowing eyes and skin (jaundice) during pregnancy or whileusing birth control pills, cancer (especially endometrial or breastcancer), undiagnosed abnormal vaginal bleeding, currently pregnant,heavy tobacco use (if 35 years old or greater). Tell your doctor yourmedical history, especially of: high cholesterol or triglyceride (fat)levels, depression, high blood pressure, gallbladder problems, thyroidproblems, any allergies. Do not smoke cigarettes. Hormonal birthcontrol (e.g., pills, injections, devices) products combined withsmoking cigarettes significantly increase your risk for strokes, bloodclots, high blood pressure, and heart attacks; especially in womenolder than 35 years of age. Ask your doctor or pharmacist or consultthe patient information leaflet that comes with this product for moredetails. Before having surgery, including dental surgery, tell thedoctor(s) that you are using this product. The drugs in this patch maycause blotchy, dark areas on your skin (melasma) and sunlight mayintensify this effect. If this occurs, avoid prolonged sun exposure,use a sunscreen, and wear protective clothing when outdoors. If you arenear-sighted or wear contact lenses, you may develop vision problems ormay have problems wearing your contact lenses. Contact your eye doctorif these problems occur. This medication device must not be used inpregnancy. If you become pregnant or think you may be pregnant, informyour doctor immediately. The medication from this patch passes intobreast milk and may have undesirable effects on the nursing infant.Consult your doctor before breast-feeding.

DRUGINTERACTIONS: Tell your doctor of all prescription and nonprescriptionmedication you may use, especially: anti-seizure medicine (e.g.,carbamazepine, felbamate, phenobarbital, phenytoin, topiramate),certain antibiotics (e.g., ampicillin, erythromycin), HIV proteaseinhibitors (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 canaffect the results of certain lab tests (e.g., blood tests such asglucose, clotting factors, or thyroid). Make sure laboratory personneland your doctors know you use this product. Do not start or stop anymedicine without doctor or pharmacist approval.

OVERDOSE:Overdose with this product is highly unlikely. If overdose issuspected, remove the patch (or patches) and contact your local poisoncontrol center or emergency room immediately. This medicine device maybe harmful if swallowed. Symptoms of overdose may include: severenausea, vomiting, unusual vaginal bleeding or irregular menstrualperiods.

NOTES: Do not share this medication patch withothers. Keep all appointments with your doctor and when havinglaboratory tests performed. You should have a complete physical examincluding blood pressure, breast exams, pelvic exams, and PAP smears atleast once a year. Follow your doct

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