Estradiol Topical gel

What is this medicine?

ESTRADIOL (es tra DYE ole) contains the female hormone estrogen. It is used for symptoms of menopause like hot flashes, night sweats, and mood changes. This medicine may also help relieve other symptoms like vaginal dryness, itching and increased or painful urination.

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

What should I tell my health care provider before I take this medicine?

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
• stroke
• systemic lupus erythematosus (SLE)
• tobacco smoker
• an unusual or allergic reaction to estrogens, other hormones, soy, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions that come with your prescription. Spread the gel into a thin layer. It is not necessary to rub or massage the gel into the skin. Wash your hands with soap and water after applying the gel. Allow the gel to dry for up to 5 minutes before dressing. Avoid fire, flame or smoking until gel has dried. Do not apply to the breast, face or in or around the vagina. Do not use your medicine more often than directed.

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

Talk to your pediatrician regarding the use of this medicine 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, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

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

This medicine may also interact with the following medications:

• antibiotics used to treat tuberculosis like rifabutin, rifampin and rifapentine
• raloxifene or tamoxifen
• warfarin

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 medicine?

Visit your health care professional for regular checks on your progress. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines.

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

If you have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke, 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 specialist.

If you are going to have elective surgery, you may need to stop taking this medicine beforehand. Consult your health care professional for advice prior to scheduling the surgery.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breakthrough bleeding and spotting
• breast tissue changes or discharge
• chest pain
• confusion, forgetfulness
• leg, arm or groin pain
• nausea, vomiting
• severe headaches
• speech problems
• stomach pain (severe)
• sudden shortness of breath
• yellowing of the eyes or skin

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

• changes in emotions or mood
• changes in sex drive or performance
• increased or decreased appetite
• skin rash, acne, or brown spots on the skin
• symptoms of vaginal infection like itching, irritation or unusual discharge
• weight gain

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.