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Vivelle Consumer Information

VIVELLE

Generic Name: estradiol topical patches (ess tra DYE ole)

Brand Names: Alora, Climara, Esclim, Estraderm, Fempatch, Vivelle, Vivelle-Dot

What is the most important information I should know about estradiol topical patches?

• Estradiol topical patches increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using estradiol topical patches lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol topical patches. Visit your doctor regularly and report any unusual vaginal bleeding right away.
• Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol topical patches.
• Do not use this medication if you are pregnant.
• Do not place the transdermal patch on your breasts or at your waistline where tight-fitting clothing may interfere with its functioning.

What are estradiol topical patches?

• Estradiol (a form of estrogen) is a female sex hormone necessary for many processes in the body.
• Estradiol topical patches are prescribed to treat the symptoms of menopause; deficiencies in ovary function, including some types of infertility and abnormal vaginal bleeding disorders; and vaginal or urethral dryness, itchiness, and burning caused by hormonal deficiencies. Some estradiol topical patches are also used to prevent postmenopausal osteoporosis. Transdermal patches release the drug slowly, and estrogen is absorbed through your skin.
• Estradiol topical patches may also be used for purposes other than those listed in this medication guide.

Who should not use estradiol topical patches?

• Do not use estradiol topical patches without first talking to your doctor if you have
• a circulation, bleeding, or blood-clotting disorder;
• undiagnosed, abnormal vaginal bleeding; or
• any type of breast, uterine, or hormone-dependent cancer.
• Using estradiol topical patches may be dangerous in some cases if you have any of the conditions listed above.
• Before using an estradiol topical patch, tell your doctor if you have
• high blood pressure, angina, or heart disease;
• high levels of cholesterol or triglycerides in your blood;
• liver disease;
• kidney disease;
• asthma;
• epilepsy;
• migraines;
• depression;
• diabetes;
• gallbladder disease;
• uterine fibroids; or
• had a hysterectomy (uterus removed).
• You may not be able to use estradiol topical patches, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Estradiol is in the FDA pregnancy category X. This means that estradiol will cause birth defects in an unborn baby. Do not use estradiol topical patches if you are pregnant or are planning a pregnancy.
• Estradiol may decrease milk flow and have other effects on milk composition. Do not use estradiol topical patches without first talking to your doctor if you are breast-feeding a baby.

How should I use estradiol topical patches?

• Use estradiol topical patches exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Remove the protective backing from the patch as directed. Avoid handing the sticky side of the patch. Apply the patch immediately after removing it from the pouch.
• Apply each patch to a clean, dry area on your abdomen, buttocks, inner thigh, upper arm, or hips as directed for the particular product you are using. Do not use the patch on your breasts or at your waistline, where clothing may interfere with its use. Follow the specific directions for application included with your patch.
• Press the patch firmly into place with the palm of your hand for about 10 seconds, making sure there is good contact, especially around the edges.
• You will either use one patch for 7 days or one patch for half of the week and another patch for the other half of the week, depending on which brand of patch you are using. Follow your doctor's instructions or ask your pharmacist for help if you do not remember. If you are using two patches per week, remember always to change the patches on the same days of the week. Allow at least 1 week to pass between applications of the patch to a given area.
• Do not cut the patches.
• When removing the patch, peel off the used patch slowly. Fold the used patch in half (sticky sides together) and throw it away out of the reach of children and pets.
• Bathing, showering, or swimming should not affect the patch, although a long, hot bath may cause it to fall off. If a patch falls off for any reason, reapply it to the same site. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.
• Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol topical patches.
• Store the estradiol topical patches in their pouches at room temperature away from moisture and heat.

What happens if I miss a dose?

• Apply the next patch soon as you remember. Continue to follow your regular schedule for changing the patch. Do not use two patches simultaneously unless your doctor directs otherwise.
• If a patch falls off for any reason, reapply it to the same site. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.

What happens if I overdose?

• An overdose of estradiol is unlikely to occur and is not likely to threaten life. If you do suspect an overdose, or if the patch has been ingested, call an emergency room or poison control left for advice.

What should I avoid while using estradiol topical patches?

• There are no restrictions on food, beverages, or activity while using estradiol topical patches unless your doctor directs otherwise.