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Ethinyl Estradiol/Norelgestromin (Transdermal) (Patch, Extended Release)

(ORTHO EVRA)
Ethinyl Estradiol/Norelgestromin (Absorbed through the skin)
Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Norelgestromin (nor-el-JES-troe-min)Prevents pregnancy.
Ortho Evra , Xulane

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to norelgestromin or ethinyl estradiol, or if you are pregnant, you have breast cancer, or you have certain heart problems.

How to Use This Medicine:
Patch

  • Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
  • Read and follow the patient instructions that come with this medicine. This medicine must be used as directed to prevent pregnancy. Ask your doctor or pharmacist if you have questions about your patch change schedule.
  • Wash your hands with soap and water before and after applying a patch.
  • Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
  • The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one.
  • Do not put the patch over burns, cuts, or irritated skin.
  • Put on a new patch if the old one has fallen off and cannot be reapplied.
  • If you forget to wear or change your patch: Carefully follow the patient instructions that come with this medicine if you forget to use a patch. If your patch falls off and is not worn for more than 24 hours, you may need to start a new patch cycle and use a second form of birth control for at least 1 week.
  • Store the patches at room temperature in the original protective pouch.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some foods and medicines can affect how ethinyl estradiol and norelgestromin combination works. Tell your doctor if you are also using St John's wort, vitamin C, acetaminophen, aprepitant, aspirin, atorvastatin, clofibric acid, cyclosporine, morphine, prednisolone, temazepam, theophylline, or tizanidine.
  • Tell your doctor if you are using medicine to treat an infection (such as fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, voriconazole), thyroid hormone, medicine for seizures (such as bosentan, carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate), or medicines to treat HIV or AIDS.
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • If you think you have become pregnant while using the medicine, tell your doctor right away.
  • Tell your doctor if you are breastfeeding or if you recently had a baby. Tell your doctor if you have diabetes, high cholesterol levels, high blood pressure, kidney disease, liver disease, migraine headaches, or a history of depression or blood clots, heart attack, or stroke. Tell your doctor if you smoke or have unusual vaginal bleeding.
  • This medicine may cause the following problems:
    • Higher risk of heart attack, stroke, or blood clots
    • Liver cancers or tumors
    • High blood pressure
    • Gallbladder disease
    • Possible risk of breast or cervical cancer
  • You may need to stop using this medicine for a few weeks before and after surgery because of the risk of blood clots.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • This medicine may not work as well in women who weigh 198 pounds (90 kilograms) or more.
  • Your doctor will check the effects of this medicine at regular visits. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, trouble breathing, coughing up blood
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Missed menstrual period
  • Numbness or weakness in your arm or leg, or on one side of your body
  • Pain in your lower leg (calf)
  • Rapid weight gain, swelling in your hands, ankles, or feet
  • Sudden or severe headache, or problems with vision, speech, or walking
  • Unusual or unexpected vaginal bleeding

If you notice these less serious side effects, talk with your doctor:

  • Breast tenderness or swelling
  • Mild headache
  • Mild nausea, vomiting, or stomach pain
  • Skin discomfort where the patch is worn
  • Vision changes or trouble wearing contact lenses

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088