Estradiol Vaginal cream

What is this medicine?

ESTRADIOL (es tra DYE ole) contains the female hormone estrogen. It is used for symptoms of menopause, like vaginal dryness and irritation.

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 levels 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 use in the vagina only. Do not take by mouth. Follow the directions on the prescription label. Read package directions carefully before using. Use the special applicator supplied with the cream. Wash hands before and after use. Fill the applicator with the prescribed amount of cream. Lie on your back, part and bend your knees. Insert the applicator into the vagina and push the plunger to expel the cream into the vagina. Wash the applicator with warm soapy water and rinse well. Use exactly as directed for the complete length of time prescribed. Do not stop using except on the advice of your doctor or health care professional.

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. This medicine is not approved for use in children.

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:

• barbiturates used for inducing sleep or treating seizures
• carbamazepine
• grapefruit juice
• medicines for fungal infections like ketoconazole and itraconazole
• raloxifene
• rifabutin
• rifampin
• rifapentine
• ritonavir
• some antibiotics used to treat infections
• St. John's Wort
• 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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tissue changes or discharge
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• nausea, vomiting
• pain, swelling, warmth in the leg
• right upper belly pain
• severe headaches
• shortness of breath
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• unusual vaginal bleeding
• 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):

• hair loss
• increased hunger or thirst
• increased urination
• symptoms of vaginal infection like itching, irritation or unusual discharge
• unusually weak or tired

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). Protect from temperatures above 40 degrees C (104 degrees C). Do not freeze. 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.