Estradiol (es-tra-DYE-ol), Norethindrone (nor-ETH-in-drone)

Treats hot flashes and other symptoms of menopause. Also supplements estrogen in women who do not have enough.

Brand Name(s):

Combipatch

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.
• 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 use oil, lotion, or powder on the skin where you place the patch. Do not put the patch over burns, cuts, or irritated skin.
• You may take a bath, shower, or swim while wearing a patch. Do not expose the patch to the sun for long periods of time.
• If a patch falls off, put it back on. If the patch does not stick completely, put on a new patch, but continue to follow your original schedule for changing to a new one.
• Fold the used patch in half with the sticky side together. Throw it in the trash, out of the reach of children and pets. Do not flush the patch down the toilet.
• 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. Never wear 2 patches at the same time.
• Store the unopened pouches at room temperature for up to 6 months.

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/norethindrone works. Tell your doctor if you are using the following:
  • Clarithromycin, efavirenz, erythromycin, itraconazole, ketoconazole, nelfinavir, nevirapine, phenylbutazone, rifabutin, rifampin, ritonavir, or St John's wort
  • Seizure medicine, including carbamazepine, phenobarbital, phenytoin

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, heart disease, asthma, diabetes, endometriosis, epilepsy, migraine headaches, porphyria, lupus, an underactive thyroid, high blood pressure, or high cholesterol. Tell your doctor if you have ever had liver problems caused by pregnancy or estrogen, or if you smoke.
• Do not use this medicine if you had a hysterectomy.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of endometrial cancer, breast cancer, or uterine cancer
  • Increased risk of dementia, especially in women 65 years of age and older
  • Gallbladder disease
• You may need to stop using this medicine for a few weeks before and after you have surgery or if you need to be on bedrest, 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. You should have regular pelvic exams, breast exams, and mammograms as directed by your doctor.
• 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 that may spread, trouble breathing, nausea, unusual sweating, fainting
• Chest pain, trouble breathing, or coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Sudden or severe stomach pain, nausea, or vomiting
• Swelling in your hands, ankles, or feet
• Unusual or unexpected vaginal bleeding or heavy bleeding
• Vision changes, vision loss, double vision, migraine headache

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

• Light, irregular vaginal bleeding or spotting
• Mild nausea, stomach pain, or upset stomach
• Redness or irritation where the patch was applied
• 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