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 estradiol or levonorgestrel, or if you have liver disease, breast or uterine cancer, a bleeding disorder, a history of blood clots, or unusual vaginal bleeding that has not been checked by your doctor. Do not use this medicine if you may be pregnant, or if you had a heart attack or stroke.

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.
• 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. Do not touch the sticky side of the patch.
• Place the patch on a different area of your abdomen or buttocks each time you apply a new one.
• Do not place the patch where your skin folds or where clothes are tight. Do not wear the patch on or near your breasts. Avoid getting sunlight on the patch while you are wearing it.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.
• Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
• Store the patches at room temperature in a closed container, away from heat, moisture, and direct light. Keep each patch in its unopened pouch until you are ready to use it.

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 estradiol/levonorgestrel works. Tell your doctor if you are using carbamazepine, clarithromycin, erythromycin, itraconazole, ketoconazole, phenobarbital, rifampin, ritonavir, St John's wort, or thyroid medicines.
• Do not put cosmetics or skin care products on the treated skin.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, asthma, diabetes, edema, endometriosis, epilepsy, migraines, porphyria, lupus, thyroid problems, heart disease, high blood pressure, high cholesterol, hereditary angioedema, or a history of cancer. Tell your doctor if you had liver problems caused by pregnancy or estrogen.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Higher risk of endometrial, breast, or uterine cancer
  • Higher risk of dementia (especially in women 65 years of age or older)
  • Gallbladder disease
• 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 before you have surgery or if you need to be on bed rest.
• 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 lump
• Chest pain, coughing up blood, trouble breathing
• Numbness or weakness on one side of your body, sudden or severe headache, problems with speech or walking
• Sudden and severe stomach pain, nausea, vomiting
• Swelling in your hands, ankles, or feet
• Unusual vaginal bleeding, spotting, discharge, or itching
• Vision changes

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

• Mild nausea, diarrhea, stomach cramps, or bloating
• Redness or itching where the patch is placed
• Swollen or tender breasts

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