Estradiol Vaginal insert

What is this medicine?

ESTRADIOL (es tra DYE ole) vaginal ring is an insert that contains a female hormone. This medicine helps relieve symptoms of vaginal irritation and dryness that occurs in some women during menopause.

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, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine may be inserted by you or your physician. Follow the directions that are included with your prescription. If you are unsure how to insert the ring, contact your doctor or health care professional. The vaginal ring should remain in place for 90 days. After 90 days you should replace your old ring and insert a new one. Do not stop using except on the advice of your doctor or health care professional.

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, 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, vorozole

This medicine may also interact with the following medications:

• carbamazepine
• certain antibiotics used to treat infections
• certain barbiturates used for inducing sleep or treating seizures
• grapefruit juice
• medicines for fungus infections like itraconazole and ketoconazole
• raloxifene or tamoxifen
• rifabutin, rifampin, or rifapentine
• ritonavir
• 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 medicine?

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.

You may bathe or participate in other activities while using this medicine. You do not need to remove the vaginal ring during sexual or other activities unless you are more comfortable doing so. Within the 90-day dosage period, you may remove the vaginal ring, rinse it with clean lukewarm (not hot or boiling) water, and re-insert the ring as 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 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). 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.