Climara Pro transdermal

You should not use estradiol and levonorgestrel if you are allergic to it, if you are pregnant, or if you have:

• a history of stroke, heart attack, or blood clots;

• a bleeding disorder;

• liver disease;

• abnormal vaginal bleeding that a doctor has not checked;

• a history of breast, uterine, or hormone-related cancer;

• if you have had a hysterectomy; or

• if you are pregnant.

Estradiol and levonorgestrel 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 this medicine 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.

Long-term use of estradiol and levonorgestrel 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 estradiol and levonorgestrel 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.

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 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 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 patch will not stick you may apply a new one.

If you need surgery or medical tests or if you will be on 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 estradiol and levonorgestrel.

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 taking estradiol and levonorgestrel.

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

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: 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 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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane, letrozole), fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene, tranexamic acid.

This medication may interfere with certain laboratory tests (including metyrapone test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Keep all regular medical and laboratory appointments. You should have regular complete physical exams (for example, once a year) which include laboratory and medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, pap smear) to monitor your progress and check for side effects. Follow your doctor's instructions for examining your own breasts, and report any lumps right away. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.

Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Missed Dose

If you forget to replace a patch at the scheduled time, replace it as soon as you remember. Do not use more than one patch at a time.

Storage

Store at room temperature. Do not remove the patch from the pouch until ready for use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (see How to Use section).Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.

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 surgery or medical tests or if you will be on 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.

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.