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

Treats hot flashes and other symptoms of menopause. Also prevents osteoporosis (bone loss) after menopause.

Brand Name(s):

Climara Pro

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.
• To use:
  • 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.
  • 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. Place the patch on a different area of your lower abdomen or stomach, 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.
  • Press the patch firmly in place with your hand for about 10 seconds.
  • If you have any adhesive left on your skin after you remove the patch, allow it to dry for 15 minutes. Then gently rub the sticky area with oil or lotion to remove the adhesive.
  • Change your patch on the same days of each week to help you remember.
  • You may take a bath, shower, or swim while wearing a patch.
  • Put on a new patch if the old one has fallen off and cannot be reapplied.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.
• To throw away a used patch: Fold the used patch in half with the sticky side together. Place it in a sturdy childproof container and throw away, out of the reach of children and pets. Do not flush the patch down the toilet.

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 eat grapefruit or drink grapefruit juice while you are using this medicine.
• Do not put cosmetics or skin care products on the treated skin.

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, seizures, migraine headaches, porphyria, lupus, thyroid problems, heart disease, edema (swelling), high blood pressure, high cholesterol, hereditary angioedema, or a history of cancer. Tell your doctor if you have had your uterus (womb) removed (hysterectomy) or if you are having surgery that will require inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of endometrial, breast, or uterine cancer
  • Increased risk of dementia (especially in women 65 years of age or older)
  • Increased risk of gallbladder disease
  • Eye or vision problems
  • High blood pressure
  • High cholesterol or fats in the blood
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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
• Blurred or other changes in vision
• Breast pain, lump, or tenderness
• Chest pain that may spread, coughing up blood, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Numbness or weakness on one side of your body, sudden or severe headache, problems with speech or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Redness, pain, burning, or itching in or near your vagina
• Unusual vaginal bleeding, spotting, discharge, or itching

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

• Back pain
• Redness or itching where the patch is placed

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