Estradiol Skin Patches

ESTRADIOL (es tra DYE ole) reduces the number and severity of hot flashes due to menopause. It may also help relieve the symptoms of menopause, such as vaginal irritation, dryness, or pain during sex. It can also be used to prevent osteoporosis after menopause. It works by increasing levels of the hormone estrogen in the body. This medication is an estrogen hormone.

This medication is for external use only. Use it as directed on the prescription label. Apply the patch, sticky side to the skin, to an area that is clean, dry and hairless. Do not cut or trim the patch. Do not wear more than 1 patch at a time. Remove the old patch before using a new patch. Use a different site each time to prevent skin irritation. Keep using it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Breast pain or tenderness
• Hair loss
• Nausea
• Stomach pain
• Vomiting

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original pouch until you are ready to use it. Get rid of any unused medication after the expiration date.

Get rid of used patches properly. Since used patches may still contain active medication, fold the patch in half so that it sticks to itself before throwing it away. Put it in the trash where children and pets cannot reach it.

It is important to get rid of the medication as soon as you no longer need it, or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Dementia
• Diabetes (high blood sugar)
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• High levels of calcium in the blood
• Hysterectomy
• Kidney disease
• Liver disease
• Low thyroid levels
• Lupus
• Migraine headaches
• Protein C/S deficiency
• Stroke
• Tobacco use
• An unusual or allergic reaction to estrogens, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medication may also interact with the following:

• Carbamazepine
• Certain antibiotics like erythromycin or clarithromycin
• Certain antiviral medications for HIV or hepatitis
• Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole
• Medications for fungus infections like itraconazole and ketoconazole
• Phenobarbital
• Raloxifene
• Rifampin
• St. John's Wort
• Tamoxifen

If you miss a dose, apply it as soon as you can. If it is almost time for your next dose, apply only that dose. Do not apply double or extra doses.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow his or her guidelines for these tests.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team.

Smoking tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are older than 35 years.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

This medication can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone medication, with this medication lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your care team may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your care team to determine the benefits and risks for you.

If you are going to need surgery, an MRI, CT scan, or other procedure, tell your care team that you are using this medication. You may need to remove the patch before the procedure.

Contact with water while you are swimming, using a sauna, bathing, or showering may cause the patch to fall off. If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your usual dose schedule.