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 estrogens, or if you are pregnant or have unusual vaginal bleeding not checked by a doctor. Do not use this medicine if you have liver disease, breast cancer, a problem with blood clotting, or a history of blood clots, heart attack, or stroke.

How to Use This Medicine:
Cream

• 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.
• Wash your hands with soap and water before and after using this medicine.
• This medicine is to be used only in the vagina. Use at bedtime unless your doctor tells you otherwise.
• Wash the applicator with mild soap and water. Do not use hot water.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container 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 medicines and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  
  • Carbamazepine, phenobarbital
  • Clarithromycin, erythromycin
  • Itraconazole, ketoconazole
  • Rifampin
  • Ritonavir
  • St John's wort
  • Thyroid medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Avoid using douches or other vaginal products unless your doctor tells you to.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding or have endometriosis, kidney, bone, or heart disease, inherited angioedema, asthma, diabetes, epilepsy, lupus, migraine headaches, porphyria, thyroid problems, or high blood pressure. Tell your doctor if you have a history of liver problems, cancer, or a family history of breast cancer or high cholesterol.
• This medicine may increase your risk for the following:
  
  • Certain cancers, including breast or uterine cancer, especially with long-term use of large doses
  • Heart attack or dementia
  • Stroke or blood clots, especially if you smoke, you have high blood pressure, high cholesterol, or diabetes, or you are overweight
• Tell your doctor if you have a sudden, severe headache or vision changes while you are taking this medicine. He may want you to have your eyes checked by an eye doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Tell any doctor or dentist who treats you that you are taking this medicine. You may need to stop taking it before you have surgery or if you need to be on bedrest.
• 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 lumps
• Chest pain, shortness of breath, or coughing up blood
• Confusion or memory problems
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your calf
• Sudden and severe stomach pain, with or without nausea, vomiting, fever, and lightheadedness
• Swelling in your hands, ankles, or feet, rapid weight gain
• Unusual vaginal bleeding or discharge
• Vision changes
• Yellowing of your skin or the whites of your eyes

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

• Breast pain or tenderness
• Diarrhea, bloating, or stomach cramps or pain

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