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.

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 package insert 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.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast lumps, tissue changes, or discharge

• high blood pressure

• migraines or severe, sudden headaches

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of a blood clot such as breathing problems; changes in vision or speech; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• swelling in your ankles, legs, or feet

• unusual vaginal bleeding

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

• breast tenderness or pain

• hair loss

• mild headache

• nausea, vomiting

• upset stomach

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 rifapentene

• raloxifene or tamoxifen

• warfarin

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.

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.

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

• protein C deficiency

• protein S deficiency

• stroke

• systemic lupus erythematosus (SLE)

• tobacco smoker

• thyroid disease

• an unusual or allergic reaction to estrogens, other hormones, soy, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

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.