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|Climara Weekly Patch

Climara Weekly Patch

Climara Weekly Patch is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), treating vulvar and vaginal atrophy, and preventing osteoporosis. It is also used for estrogen replacement therapy after failure of the ovaries and to relieve symptoms of breast cancer.

Climara Weekly Patch is an estrogen hormone used to provide the female hormone when the body no longer produces enough.

Do NOT use Climara Weekly Patch if:

• you are allergic to any ingredient in Climara Weekly Patch
• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
• you have known or suspected breast cancer (unless directed by your doctor), or you have cancers that are estrogen-dependent
• you have blood clots, circulation disorders, or liver problems
• you have had a recent heart attack or stroke

Contact your doctor or health care provider right away if any of these apply to you.

Before using Climara Weekly Patch:

Some medical conditions may interact with Climara Weekly Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a family history of breast cancer, or you have breast lumps or disease, or an abnormal mammogram
• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
• if you have abnormal calcium levels in the blood, asthma, cancer, certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
• if you smoke or will be having surgery

Some MEDICINES MAY INTERACT with Climara Weekly Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, tacrine or because their actions and the risk of their side effects may be increased by Climara Weekly Patch
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Climara Weekly Patch
• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Climara Weekly Patch"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Climara Weekly Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Climara Weekly Patch:

Use Climara Weekly Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Climara Weekly Patch. Talk to your pharmacist if you have questions about this information.
• If you are switching from oral estrogen to Climara Weekly Patch, stop taking the oral estrogen and wait 1 week before using Climara Weekly Patch. However, if symptoms return, you may start using Climara Weekly Patch sooner.
• One patch is usually applied to the skin, worn for 1 week, and then replaced. Follow the dosing schedule carefully.
• Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.
• Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
• After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
• Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly.
• Grapefruit and grapefruit juice may increase the risk of Climara Weekly Patch"s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Climara Weekly Patch.
• If you forget to change the patch as scheduled, change it as soon as possible and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Climara Weekly Patch.

Important safety information:

• Climara Weekly Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Climara Weekly Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Limit alcoholic beverages while you are using Climara Weekly Patch.
• Climara Weekly Patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
• Climara Weekly Patch may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Climara Weekly Patch.
• Follow your doctor"s instructions for examining your breasts and report any lumps immediately.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Climara Weekly Patch.
• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
• This medicine may increase the risk of breast and endometrial cancer.
• Diabetes patients - Climara Weekly Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Climara Weekly Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Climara Weekly Patch.
• Lab tests, including physical exams and blood pressure, may be performed while you use Climara Weekly Patch. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
• Climara Weekly Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use this medicine if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Climara Weekly Patch may be found in breast milk. If you are or will be breast-feeding while you use Climara Weekly Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Climara Weekly Patch:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Store Climara Weekly Patch at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Climara Weekly Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Climara Weekly Patch, please talk with your doctor, pharmacist, or other health care provider.
• Climara Weekly Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Climara Weekly Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.