Climara Pro is a transdermal patch that contains estradiol and levonorgestrel as active ingredients. It belongs to the class of hormone replacement therapies and releases these hormones continuously through intact skin. The patch comes in a 22 cm size with a daily release rate of 0.045 mg of estradiol and 0.015 mg of levonorgestrel. Inactive ingredients include an acrylate copolymer adhesive and polyvinylpyrrolidone/vinyl acetate copolymer.

How should I use this medication?

This medication is for external use only. Follow the directions on the prescription label. Tear open the pouch, do not use scissors. Remove the stiff protective liner covering the adhesive. Try not to touch the adhesive. Apply the patch, sticky side to the skin, to an area that is clean, dry and hairless. Avoid injured, irritated, calloused, or scarred areas. Do not apply the skin patches to your breasts or around the waistline. Use a different site each time to prevent skin irritation. Do not cut or trim the patch. Do not stop using except on the advice of your care team. Do not wear more than one patch at a time unless you are told to do so by your care team.

Contact your care team about the use of this medication in children. Special care may be needed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, apply it as soon as you can. If it is almost time for your next dose, apply only that dose. Do not apply double or extra doses.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not store any patches that have been removed from their protective pouch. Throw away any unused medication after the expiration date. Dispose of used patches properly. Since used patches may still contain active hormones, fold the patch in half so that it sticks to itself prior to disposal.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Breast pain or tenderness
• Headache
• Irritation at application site
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease or blood clots
• Breast, cervical, endometrial, or uterine cancer
• Diabetes
• Endometriosis
• Fibroids
• Gallbladder disease
• Heart disease or recent heart attack
• High blood cholesterol
• High blood pressure
• High level of calcium in the blood
• Hysterectomy
• Kidney disease
• Liver disease
• Mental depression
• Migraine headaches
• Porphyria
• Stroke
• Systemic lupus erythematosus (SLE)
• Tobacco smoker
• Vaginal bleeding
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medication may also interact with the following:

• Barbiturates, like phenobarbital
• Carbamazepine
• Certain antibiotics used to treat infections
• Grapefruit juice
• Medications for fungus infections like itraconazole and ketoconazole
• Raloxifene or tamoxifen
• Rifabutin, rifampin, or rifapentine
• Ritonavir
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow his or her guidelines for these tests.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your care team.

If you are going to have surgery or an MRI, you may need to stop taking this medication. Consult your care team for advice before you schedule the surgery.

Contact with water while you are swimming, using a sauna, bathing, or showering may cause the patch to fall off. If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your usual dose schedule.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots.

Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps.

Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older.

If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).