Climara Pro is a skin patch containg estradiol and levonorgestrel. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Climara Pro is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women.

Climara Pro may also be used for purposes other than those listed here.

Do not use Climara Pro patches if you are pregnant.

You should not use Climara Pro if you have had a hysterectomy, or if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, a blood clot, if you will be having major surgery.

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

To be sure Climara Pro is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

Before taking this medicine

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

• a stroke, heart attack, or blood clots;

• a bleeding disorder;

• liver disease;

• abnormal vaginal bleeding that a doctor has not checked;

• breast, uterine, or hormone-related cancer;

• a hysterectomy;

• or if you are pregnant.

Climara Pro 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 Pro is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, 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);

• hereditary angioedema (an immune system disorder);

• kidney disease;

• gallbladder disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• a thyroid disorder; or

• high levels of calcium in your blood.

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

Do not use Climara Pro 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 and levonorgestrel can pass into breast milk. This medication may slow breast milk production. Do not use if you are breast-feeding a baby.

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the Climara Pro skin patch to clean, dry skin on your lower stomach. The patch should be worn around-the-clock for one week. Choose a different place on your lower stomach each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Do not apply a Climara Pro 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.

If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the Climara Pro patch will not stick you may apply a new one.

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

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 Pro.

Store Climara Pro at room temperature away from moisture and heat. Keep this medicine in the foil pouch until ready to use.

Usual Adult Dose of Climara Pro for Postmenopausal Symptoms:

For the treatment of postmenopausal symptoms and/or the prevention of postmenopausal osteoporosis:

One (0.045 mg-0.015 mg/24 hr) patch applied weekly.

The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.

If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the weekly dosing interval.

Usual Adult Dose of Climara Pro for Prevention of Osteoporosis:

For the treatment of postmenopausal symptoms and/or the prevention of postmenopausal osteoporosis:

One (0.045 mg-0.015 mg/24 hr) patch applied weekly.

The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.

If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the weekly dosing interval.

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

• a stroke, heart attack, or blood clots;

• a bleeding disorder;

• liver disease;

• abnormal vaginal bleeding that a doctor has not checked;

• breast, uterine, or hormone-related cancer;

• a hysterectomy;

• or if you are pregnant.

Climara Pro 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 Pro is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, 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);

• hereditary angioedema (an immune system disorder);

• kidney disease;

• gallbladder disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• a thyroid disorder; or

• high levels of calcium in your blood.

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

Do not use Climara Pro 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 and levonorgestrel can pass into breast milk. This medication may slow breast milk production. Do not use if you are breast-feeding a baby.

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

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

Avoid exposing the patch to sunlight or tanning beds while you are wearing it on your skin.

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 signs of an allergic reaction to Climara Pro: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

• 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• vomiting, jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding;

• a lump in your breast;

• fluid retention (swelling, rapid weight gain); or

• high levels of calcium in your blood--nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common Climara Pro side effects may include:

• nausea, vomiting, bloating, stomach cramps;

• headache;

• breast pain;

• hair loss; or

• vaginal itching or discharge, breakthrough bleeding.

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.

Many drugs can interact with estradiol and levonorgestrel. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• St. John's wort;

• an antibiotic or antifungal medicine;

• heart or blood pressure medicine;

• antiviral medicine to treat hepatitis or HIV/AIDS;

• seizure medicine; or

• tuberculosis medicine.

This list is not complete and many other drugs can interact with estradiol and levonorgestrel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.