Estradiol/levonorgestrel (Absorbed through the skin)

Introduction

Estradiol (es-tra-DYE-ol), Levonorgestrel (lee-voe-nor-JES-trel)

Treats hot flashes and other symptoms of menopause in a woman who has not had her uterus removed (hysterectomy). This medicine also prevents weak bones (osteoporosis) after menopause.

Brand Name(s)

Climara Pro

There may be other brand names for this medicine.

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.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask 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.Do not touch the sticky side of the patch with your fingers.
• Place the patch on a smooth skin area of your lower abdomen (pelvic area). Press the patch into place firmly for about 10 seconds. Each time you put on a new patch, wear it on a new place within the smooth area of your lower abdomen.
• Do not place the patch in a crease or fold of your skin. Do not wear the patch in an area where clothes are tight, such as your waistline. 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.

If a dose is missed:

• 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.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to estradiol or levonorgestrel, or to other hormone medicines. Do not use this medicine if you are pregnant, or if you have abnormal vaginal bleeding that has not been checked by a doctor. You should not use this medicine if you have a history of cancer of the breast, ovary, or uterus. Do not use if you have liver disease or a history of heart attack, stroke, or blood clots. You should not use this medicine if you have had your uterus removed.

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. Keep each patch in its unopened pouch until you are ready to use it.
• 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.

Drugs and Foods to Avoid

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

• Before you start using this medicine, tell your doctor if you are already using estrogen, progestin, or another hormone medicine.
• Make sure your doctor also knows if you are using rifampin (Rifadin®, Rifater®), St. John's wort, or medicine for seizures (such as carbamazepine, phenobarbital). Tell your doctor if you use antibiotics (such as erythromycin, Biaxin®), or medicine to treat infection, such as itraconazole, ketoconazole, Sporanox®, or Norvir®.
• Do not use cosmetics or other skin care products on the treated skin areas.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• This medicine should not be used to treat or prevent heart disease or stroke. In fact, hormone therapy can increase your risk of certain heart or blood vessel problems. Tell your doctor if you have a history of heart attack, stroke, high blood pressure, congestive heart failure, blood clots, or circulation problems.
• Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.
• This medicine might make your body keep more fluid than normal ("retain water"). Retaining water can make asthma, epilepsy, migraine headaches, heart disease, or kidney disease worse. Tell your doctor if you have any of these problems. Also make sure your doctor knows if you have lupus or an underactive thyroid.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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 changes or lumps.
• Chest pain, or coughing up blood.
• Fever, chills, cough, or sore throat.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Shortness of breath, cold sweat, and bluish-colored skin.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Vaginal bleeding, spotting, discharge, or itching.
• Yellowing of your skin or the whites of your eyes.

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

• Back or joint pain.
• Breast pain, swelling, or tenderness.
• Itching, redness, or swelling where you wear the patch.
• Mild skin rash, itching, or discoloration.
• Nervousness, mood changes or irritability.
• Nausea, vomiting, diarrhea, or stomach cramps.
• Runny or stuffy nose.
• Weight gain or loss.

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