Climara is a skin patch that contains an estrogen called estradiol. Estrogens are female sex hormones produced by the ovaries. Estrogens are necessary for many processes in the body.

Climara skin patches are used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Climara is also used to prevent postmenopausal osteoporosis, or to treat ovarian disorders.

You should not use Climara if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, a blood clot, or if you will be having major surgery.

Do not use Climara if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Using Climara can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.

Before taking this medicine

You should not use Climara if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Climara should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Climara is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Using Climara may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Climara long term.

FDA pregnancy category X. Do not use Climara if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

Estradiol can pass into breast milk. Climara may slow breast milk production. Do not use Climara skin patches if you are breast-feeding a baby.

Use Climara exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Climara may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply the Climara skin patch to clean, dry skin on your stomach or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.

Remove the patch and apply a new one on the same day each week to stay on your once-weekly dosing schedule.

If a Climara patch falls off, try sticking it back into place. If it does not stick well, put on a new patch on a different skin area and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

If you need surgery or medical tests or if you will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Climara.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Climara.

Store at room temperature away from moisture and heat. Keep each Climara patch in its pouch until you are ready to use it.

After removing a skin patch, fold it in half so it sticks together. Discard the folded patch in a place children and pets cannot get to.

You should not use Climara if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Climara should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Climara is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Using Climara may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Climara long term.

FDA pregnancy category X. Do not use Climara if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

Estradiol can pass into breast milk. Climara may slow breast milk production. Do not use Climara skin patches if you are breast-feeding a baby.

If you forget to change your patch, change it as soon as you remember or wait until your next scheduled patch change. Do not apply two patches at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction to Climara transdermal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a breast lump;

• memory problems, confusion, unusual behavior; or

• high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common Climara side effects may include:

• headache, back pain;

• stuffy nose, sinus pain, sore throat;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• bloating, stomach cramps, nausea, vomiting;

• breast pain;

• redness or irritation where the patch was worn;

• thinning scalp hair; or

• fluid retention (swelling, rapid weight gain).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.