Ethinyl estradiol/norelgestromin (Absorbed through the skin)

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

Introduction

Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Norelgestromin (nor-el-JES-troe-min)

Prevents pregnancy. This medicine is a birth control patch.

Brand Name(s)

Ortho Evra

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to norelgestromin/ethinyl estradiol, or if you are pregnant, have unusual vaginal bleeding, or are on bedrest after surgery. You should not use this medicine if you have high blood pressure, certain heart problems, kidney disease, or diabetes. Do not use this medicine if you have breast or uterine cancer, liver disease, or certain types of headaches. You should not use this medicine if you have ever had a blood clot, heart attack, or stroke. Do not use this medicine if you have ever had jaundice caused by pregnancy or birth control.

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. Talk to your doctor or pharmacist if you have any questions.
  • 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 a dose is missed:

  • This medicine must be used on a regular fixed schedule to prevent pregnancy. It is very important to follow instructions for using the skin patches. 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 back-up birth control method for at least 1 week.
  • The patient instructions that come with this medicine explain what to do if you forget to use a patch at any time during your cycle. Carefully follow these instructions if you forget to use a patch. You may need to change your cycle schedule for applying a new patch.
  • Ask your doctor or pharmacist if you have questions or concerns about your patch change schedule.

Warnings While Using This Medicine

  • Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
  • Make sure your doctor knows if you are breast feeding, or if you have had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have migraine headaches, high cholesterol in the blood, fluid retention (edema), gallbladder disease, or depression.
  • Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • Check with your eye doctor if you wear contact lenses and you have vision problems or eye discomfort.
  • This medicine may not work as well in women who weigh 198 pounds or more.
  • This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
  • Using this medicine may increase your risk of blood clots, stroke, or heart attack. Your risk of these serious medical problems is even greater if you smoke cigarettes or if you are over age 35.
  • You will be exposed to more estrogen if you use this medicine than if you use a typical birth control pill. Increased estrogen exposure may increase the risk of side effects. Talk to your doctor about this risk.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

How to Store and Dispose of This Medicine

  • Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
  • Fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it. You will also need to throw away old patches after the expiration date has passed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid

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

  • This medicine may not work as well if you are also using antibiotics (such as ampicillin, griseofulvin, tetracycline, or Sumycin®), medicine for seizures such as barbiturates (phenobarbital), bosentan (Tracleer®), carbamazepine (Tegretol®), felbamate (Felbatol®), oxcarbazepine (Trileptal®), phenytoin (Dilantin®), phenylbutazone (Butazolidin®), or topiramate (Topamax®), or drugs used to treat HIV or AIDS such as ritonavir (Norvir®).
  • Make sure your doctor knows if you are also using rifampin (Rifadin®, Rimactane®), St. John's Wort, atorvastatin (Lipitor®), vitamin C (ascorbic acid), acetaminophen (Tylenol®), aspirin, itraconazole (Sporanox®), ketoconazole (Nizoral®), cyclosporine (Neoral®, Sandimmume®), clofibric acid, lamotrigine (Lamictal®), morphine (Avinza®, MS Contin®, Roxanol®), prednisolone, theophylline (Theo-Dur®), or temazepam (Restoril®).

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, shortness of breath, or coughing up blood.
  • Dark-colored urine or pale stools.
  • Irregular or missed menstrual period.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Numbness or weakness in your arm or leg, or on one side of your body.
  • Pain in your lower leg (calf).
  • Rapid weight gain.
  • Severe depression or mood changes.
  • Skin rash or itching.
  • Sudden or severe headache, or problems with vision, speech, or walking.
  • Swelling in your hands, ankles, or feet.
  • Yellowing of your skin or the whites of your eyes.

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

  • Acne, mild skin rash, or darkened skin on your face.
  • Breast tenderness or swelling.
  • Contact lens discomfort, or change in vision.
  • Loss of scalp hair.
  • Mild nausea, vomiting, or stomach pain.
  • Mood changes, depression, nervousness, or dizziness.
  • Skin discomfort where the patch is worn.
  • Unexpected vaginal bleeding.
  • Vaginal itching or discharge.
  • Weight gain.
Review Date: March 4, 2014
The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
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