WHAT IS Estrace/Estradiol ORAL TABLETS?

ESTRADIOL/Estrace is an estrogen. It is mostly used as hormone replacement in menopausal women. It helps to treat hot flashes and prevent osteoporosis. It is also used to treat women with low estrogen levels or those who have had their ovaries removed. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

WHERE SHOULD I KEEP Estrace/Estradiol?

Keep out of the reach of children.

HOW SHOULD I USE Estrace/Estradiol?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. Take this medicine at the same time each day and in the order directed on the package. Do not take your medicine more often than directed.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed.

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

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

WHAT SHOULD I WATCH FOR WHILE USING Estrace/Estradiol?

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

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 right away and contact your doctor or health care professional.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, 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 doctor or health care professional.

This medicine 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 drug, with this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor 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 health care professional to determine the benefits and risks for you.

If you are going to have surgery, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.

WHAT MAY INTERACT WITH Estrace/Estradiol?

Do not take this medicine with any of the following:

• aromatase inhibitors like aminoglutethimide, anastrozole/Arimidex, exemestane, letrozole/Femara, testolactone

This medicine may also interact with the following:

• ritonavir/Norvir
• St. John's Wort
• raloxifene/Evista or tamoxifen/Nolvadex
• grapefruit juice
• warfarin/Coumadin
• rifabutin, rifampin, or rifapentine
• carbamazepine/Tegretol
• certain barbiturates or benzodiazepines used for inducing sleep or treating seizures
• certain antibiotics used to treat infections
• medicines for fungus infections like itraconazole/Sporanox and ketoconazole/Nizoral

This list may not describe all possible interactions. Give your health care providers 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 SIDE EFFECTS MAY I NOTICE FROM Estrace/Estradiol?

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

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

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

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

This list may not describe all possible side effects.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Estrace/Estradiol?

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

• systemic lupus erythematosus (SLE)
• hysterectomy
• breast-feeding
• pregnant or trying to get pregnant
• breast, cervical, endometrial, ovarian, liver, or uterine cancer
• abnormal vaginal bleeding
• gallbladder disease
• kidney disease
• blood vessel disease or blood clots
• diabetes
• high level of calcium/Phoslo in the blood
• migraine headaches
• heart disease or recent heart attack
• dementia
• tobacco smoker
• high blood pressure
• high cholesterol
• liver disease
• stroke
• an unusual or allergic reaction to estrogens, other hormones, medicines, foods, dyes, or preservatives

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.