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 norethindrone, you are pregnant, or you have liver disease. Do not use it if you have had breast cancer, uterine cancer, unusual vaginal bleeding, or problems with blood clots (such as deep vein thrombosis or stroke).

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine comes in a dispenser pack with a calendar reminder dial.
  
  • To use this dispenser, first turn the inner disc so the current day of the week is lined up with the plastic tab. Pull the plastic tab up and break if off. Remove the first tablet.
  • To get the next tablet out (on the next day), turn the dial one space clockwise as shown by the arrow.
  • The dial can be turned only after the tablet in the opening has been removed. This will help you remember to take 1 tablet every day.
• 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 estradiol/norethindrone works. Tell your doctor if you are using St John's wort, carbamazepine, clarithromycin, erythromycin, itraconazole, ketoconazole, phenobarbital, rifampin, or ritonavir.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 have had a heart attack, bleeding problems, or any kind of cancer.
• Tell your doctor if you have kidney disease, heart disease, asthma, diabetes, endometriosis, epilepsy, migraine headaches, porphyria, lupus, an underactive thyroid, high blood pressure, or high cholesterol. Tell your doctor if you have ever had liver problems caused by pregnancy or estrogen, if you smoke, or if you had a hysterectomy.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Higher risk of endometrial cancer, breast cancer, or uterine cancer
  • Higher risk of dementia
  • Gallbladder disease
  • High calcium levels
• You may need to stop using this medicine for a few weeks before and after surgery, or if you need to stay in bed for a long time. This is because of the risk of blood clots.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. You should have regular pelvic exams, breast exams, and mammograms as directed by your doctor.
• 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 that may spread, trouble breathing, coughing up blood, unusual sweating, fainting
• Numbness or weakness on one side of your body
• Sudden or severe headache, problems with vision, speech, or walking
• Sudden or severe stomach pain, nausea, or vomiting
• Unusual or unexpected vaginal bleeding or heavy bleeding
• Vision changes, vision loss, double vision, migraine headache

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

• Back pain
• Light, irregular vaginal bleeding or spotting
• Mild headache or trouble sleeping
• Nausea, stomach pain, or upset stomach
• Swelling in your hands, ankles, or feet
• 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