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

Prevents pregnancy.

Brand Name(s):

Xulane, Zafemy

When This Medicine Should Not Be Used:

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.
• Carefully follow your doctor's instructions about when to start using your medicine. You may begin using the patch on the first day of your menstrual period, or on the first Sunday after your period begins.
• You should also use a second form of birth control (including condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.
• Apply your patch on the same day of every week ("Patch Change Day") for 3 weeks in a row.
• 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 or change 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 their original protective pouches.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some foods and medicines can affect how ethinyl estradiol/norelgestromin combination works. Tell your doctor if you are using any of the following:
  • Acetaminophen, aprepitant, ascorbic acid, bosentan, clofibric acid, cyclosporine, morphine, prednisolone, salicylic acid, St John's wort, temazepam, theophylline, tizanidine
  • Medicine to treat an infection (including fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampicin, voriconazole)
  • Medicine to treat HIV/AIDS (including amprenavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, etravirine, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, ritonavir, tipranavir/ritonavir)
  • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate)
  • Medicine to treat thyroid problems
• 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 this 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 kidney disease, epilepsy, diabetes, high cholesterol levels, high blood pressure, gallbladder disease, migraine headaches, irregular monthly periods, or a history of depression, or chloasma gravidarum (skin discoloration during pregnancy). Tell your doctor if you are having a surgery that requires inactivity for a long time or if you smoke.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Liver problems (including liver cancers or tumors)
  • High blood pressure
  • Gallbladder disease
  • High cholesterol in the blood
  • Possible risk of breast or cervical cancer
• This medicine may not work as well in women who weigh 198 pounds (90 kilograms) or more.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. You may need to stop using this medicine for a few weeks before and after surgery because of the risk of blood clots.
• Your doctor will check your progress and 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
• Breast lumps, tenderness, pain, swelling, or discharge
• Chest pain or tightness, trouble breathing, coughing up blood
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Irregular, late, or 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 and severe stomach pain, nausea, vomiting, lightheadedness
• 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:

• Darkened skin on your face
• Mood changes, depression, nervousness
• 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