When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to estradiol, or if you have liver disease, breast or uterine cancer, a bleeding disorder, a history of blood clots, or unusual vaginal bleeding that has not been checked by your doctor. Do not use this medicine if you may be pregnant, or if you had a heart attack or stroke.

How to Use This Medicine:
Cream, Insert, Suppository

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Vaginal cream:
  
  • Measure the cream using the marks on the plastic applicator. Make sure you use the correct mark for your specific dose.
• Vaginal ring:
  
  • Once the ring is in place, you should not be able to feel it. If you feel uncomfortable, the ring may not be inserted far enough. Gently push the ring farther into your vagina. If you feel pain, talk to your doctor.
  • The ring may move down accidently. This can happen if you strain to have a bowel movement. Gently push the ring back into place. If the ring comes all the way out, rinse it with warm water and put it back in. Call your doctor if the ring comes out several times.
  • Do not flush a used vaginal ring down the toilet. Throw it in the trash.
• Vaginal tablet:
  
  • The tablet should be used only in your vagina. Do not swallow the tablet.
  • It is best to use this medicine at the same time each day.
  • Do not take the tablet out of the applicator. If the tablet comes out of the applicator when you open it, carefully put it back in. If the tablet falls out of the applicator when you try to insert it, throw it away and use a new applicator and tablet.
• Store the unopened packages of this medicine at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how estradiol works. Tell your doctor if you are using carbamazepine, clarithromycin, erythromycin, itraconazole, ketoconazole, phenobarbital, rifampin, ritonavir, St John's wort, or thyroid medicines.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Ask your doctor before you use other products or medicines in your vagina. You may need to remove the ring first.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, asthma, diabetes, edema, endometriosis, epilepsy, migraines, porphyria, lupus, thyroid problems, heart disease, high blood pressure, high cholesterol, hereditary angioedema, or a history of cancer. Tell your doctor if you had liver problems caused by pregnancy or estrogen. Tell your doctor if you have any problems with your vagina or in your pelvic area, such as prolapse.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Higher risk of endometrial, breast, or uterine cancer
  • Higher risk of dementia (especially in women 65 years of age or older)
  • Gallbladder disease
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. You may need to stop using this medicine before surgery or if you need to be on bed rest.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lump
• Chest pain, coughing up blood, trouble breathing
• Fever, diarrhea, nausea, vomiting, muscle pain, dizziness, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with speech or walking
• Redness, pain, burning, or itching in or near your vagina
• Sudden and severe stomach pain, nausea, vomiting
• Swelling in your hands, ankles, or feet
• Unusual vaginal bleeding, spotting, discharge, or itching
• Vision changes

If you notice these less serious side effects, talk with your doctor:

• Mild nausea, diarrhea, stomach cramps, or bloating
• Swollen or tender breasts

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088