Estradiol Topical Spray

What is this medication?

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 works by increasing levels of the hormone estrogen in the body. This medication is an estrogen hormone.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Evamist

What should I tell my care team before I take this medication?

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
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• High level of calcium in the blood
• Hysterectomy
• Kidney disease
• Liver disease
• Migraine headaches
• Protein C/S deficiency
• Stroke
• Systemic lupus erythematosus (SLE)
• Tobacco smoker
• An unusual or allergic reaction to estrogens, other hormones, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Follow the directions on the prescription label. Your care team will show you how to apply this medication. Apply this medication at the same time each day to clean, dry, unbroken skin on the inside of the forearm between the elbow and the wrist. If you take a bath or shower or use a sauna, apply this medication after the bath, shower, or sauna, and once the skin is dry. Avoid fire, flame or smoking until the spray has dried. Do not apply to the breast. Do not use your medication more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Contact your care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, skip the missed dose and get back on your normal schedule. Do not use double or extra doses.

What may interact with this medication?

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:

• Antibiotics used to treat tuberculosis like rifabutin, rifampin and rifapentine
• Antiviral medications for HIV or AIDS
• Certain antibiotics like erythromycin and clarithromycin
• Carbamazepine
• Grapefruit juice
• Medications for fungal infections like ketoconazole and itraconazole
• Phenobarbital
• Raloxifene
• Tamoxifen
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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 their 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.

This medication can transfer from your body to others. If a person or pet comes in contact with the area where this medication was applied to your skin, they may have a serious risk of side effects. If you cannot avoid skin-to-skin contact with another person, make sure the site where this medication was applied is covered with clothing. If accidental contact happens, the skin of the person or pet should be washed right away with soap and water.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are more than 35 years old. You are strongly advised not to smoke.

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

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.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.