When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had a severe allergic reaction to estrogens, you have liver disease, cancer of the breast, uterus, or ovaries, or a history of blood clotting problems, heart attack, or stroke. Do not use it if you may be pregnant, are breastfeeding, or have unusual vaginal bleeding that has not been checked by a doctor.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at the same time each day.
• Your doctor may want you to take calcium or vitamin D supplements while you take this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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 can affect how estrogens work. Tell your doctor if you are taking a blood thinner (such as warfarin), thyroid replacement medicine, or other female hormones.

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 have endometriosis or a history of cancer. Tell your doctor if you have asthma, diabetes, epilepsy, gallbladder, heart, or kidney disease, high or low calcium, lupus, migraine headaches, porphyria, or thyroid problems. Tell your doctor if you have high blood pressure, high cholesterol, a family history of high cholesterol, or a history of liver problems caused by pregnancy or estrogen.
• This medicine may increase your risk for the following:
  
  • Dementia
  • Heart attack, blood clots, or stroke, especially if you smoke, have diabetes or high cholesterol, or are overweight
  • Breast or ovarian cancer
  • Uterine cancer if you take this medicine without a progestin medicine
• Stop taking this medicine and check with your doctor immediately if you have a severe headache or sudden loss of vision or vision changes. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for side effects.
• 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 changes, lumps, or discharge (in women or men)
• Chest pain, trouble breathing, or coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your calf
• Seizures
• Swelling in your face, hands, ankles, or feet
• Unusual vaginal bleeding
• Yellow skin or eyes

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

• Breast pain or tenderness
• Change in weight or hair growth
• Nausea, vomiting, stomach pain, bloating

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