Bazedoxifene Acetate (ba-ze-DOX-i-feen AS-e-tate), Conjugated Estrogens (KON-joo-gay-ted ES-troe-jenz)

Treats hot flashes during menopause. Also prevents osteoporosis after menopause.

Brand Name(s):

Duavee

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Your doctor may also want you to take vitamin D and calcium supplements.
• 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. Keep your medicine in the original package until you are ready to use it. Do not place the tablets in pill boxes or pill organizers. Use the medicine within 60 days after you open the foil pouch.

Drugs and Foods to Avoid:

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

• Do not take other medicines that contain estrogen or progestin while you are being treated with this medicine.
• Some foods and medicines can affect how Duavee® works. Tell your doctor if you are using carbamazepine, itraconazole, ketoconazole, phenobarbital, phenytoin, rifampin, ritonavir, or St John's wort.
• 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 had a heart attack, have bleeding problems, or had any kind of cancer (especially breast or uterine cancer).
• Tell your doctor if you have kidney disease, heart disease, asthma, diabetes, epilepsy, hereditary angioedema, gallbladder disease, migraine headaches, porphyria, lupus, an underactive thyroid, high blood pressure, or high blood cholesterol. Tell your doctor if you have ever had liver problems caused by pregnancy or estrogen, or if you smoke.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of endometrial cancer, breast cancer, or uterine cancer
  • Increased risk of dementia, especially in females 65 years of age and older
  • Gallbladder problem
  • Eye or vision problems
  • High blood pressure
  • High cholesterol or fats in the blood
  • Thyroid problems
• You may need to stop using this medicine for a few weeks before and after you have surgery or if you need to stay in bed for a long time, because of the risk of blood clots.
• 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 do lab tests at regular visits to check on the effects of this medicine. 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 or tenderness
• Chest pain that may spread, trouble breathing, nausea, coughing up blood
• Confusion, weakness, uneven heartbeat, numbness in your hands, feet, or lips
• 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:

• Mild diarrhea, nausea, stomach pain or upset

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