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|Estradiol/Levonorgestrel Weekly Patch Estradiol/Levonorgestrel

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Estradiol/Levonorgestrel Weekly Patch

Generic Name: Estradiol/Levonorgestrel Transdermal Weekly Patch (ESS-truh-DIE-ole/LEE-voe-nor-jes-trel)
Brand Name: Climara Pro

Estrogens have been reported to increase the chance of womb (endometrial) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time Estradiol/Levonorgestrel Weekly Patch is used and the amount of estrogen per dose. Therefore, Estradiol/Levonorgestrel Weekly Patch should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.

Estradiol/Levonorgestrel Weekly Patch is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness).

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

Do NOT use Estradiol/Levonorgestrel Weekly Patch if:

you are allergic to any ingredient in Estradiol/Levonorgestrel 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 other cancer that is estrogen-dependent
you have blood clots, circulation disorders, liver problems, or the blood disease porphyria
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 Estradiol/Levonorgestrel Weekly Patch:

Some medical conditions may interact with Estradiol/Levonorgestrel 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 pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
you have breast lumps or disease, an abnormal mammogram, or a family history of breast cancer
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, 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 Estradiol/Levonorgestrel 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), tacrine, or succinylcholine because their actions and side effects may be increased by Estradiol/Levonorgestrel Weekly Patch
Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Estradiol/Levonorgestrel Weekly Patch
Hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), or rifampin because they may decrease Estradiol/Levonorgestrel Weekly Patch"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol/Levonorgestrel 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 Estradiol/Levonorgestrel Weekly Patch:

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

If you are switching from oral estrogen to Estradiol/Levonorgestrel Weekly Patch, stop taking the oral estrogen and wait 1 week before using Estradiol/Levonorgestrel Weekly Patch. However, if symptoms return, you may start using Estradiol/Levonorgestrel Weekly Patch sooner.
An extra patient leaflet is available with Estradiol/Levonorgestrel Weekly Patch. Talk to your pharmacist if you have questions about this information.
One patch is usually applied to the skin and 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.
When it is time to change the patch, remove it slowly, fold in half (sticky sides together), and throw it away 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.
Do not eat grapefruit or drink grapefruit juice while you use Estradiol/Levonorgestrel 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 Estradiol/Levonorgestrel Weekly Patch.

Important safety information:

Estradiol/Levonorgestrel Weekly Patch may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Estradiol/Levonorgestrel Weekly Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Talk to your doctor before you take Estradiol/Levonorgestrel Weekly Patch if you drink more than 3 drinks with alcohol per day.
Estradiol/Levonorgestrel 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.
Estradiol/Levonorgestrel Weekly Patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke, especially if you are older than 35 years old.
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 Estradiol/Levonorgestrel 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 Estradiol/Levonorgestrel 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.
Estradiol/Levonorgestrel Weekly Patch may increase the risk of breast and endometrial cancer.
Diabetes patients - Estradiol/Levonorgestrel Weekly Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Estradiol/Levonorgestrel Weekly Patch may affect certain lab test results. Make sure laboratory personnel and your doctors know you take Estradiol/Levonorgestrel Weekly Patch.
Lab tests, including complete physical exams, breast and pelvic exams, periodic mammograms, Pap smears, and blood pressure measurements, may be performed while you use Estradiol/Levonorgestrel Weekly Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Estradiol/Levonorgestrel Weekly Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Estradiol/Levonorgestrel Weekly Patch if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not know if Estradiol/Levonorgestrel Weekly Patch if found in breast milk. If you are or will be breast-feeding while you use Estradiol/Levonorgestrel Weekly Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Estradiol/Levonorgestrel 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:

Arthritis; back pain; bladder infection; bone and limb pain; breakthrough bleeding; breast tenderness; bronchitis; carpal tunnel syndrome; changes in sex drive; constipation; diarrhea; dizziness; ear infection; emotional disturbance; flu-like symptoms (fever, headache, sore throat); fungal infection; herpes; indigestion; joint and muscle strain; lightheadedness; muscle cramps, pain, and spasms; nausea; neck pain; nose and throat pain; sinus headache; skin redness/irritation or hair loss at the application site; sleeplessness; stomach bloating and upset; swelling of the legs and feet; tiredness; tooth abscess; toothache; upper respiratory tract infection; urinary tract infection; vaginal infection; vomiting; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; breast pain; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, severe depression, memory loss); pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; 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.

Proper storage of Estradiol/Levonorgestrel Weekly Patch:

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

General information:

If you have any questions about Estradiol/Levonorgestrel Weekly Patch, please talk with your doctor, pharmacist, or other health care provider.
Estradiol/Levonorgestrel 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 Estradiol/Levonorgestrel 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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