DUAVEE- estrogens, conjugated and bazedoxifene acetate tablet, film coated 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

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Patient Information

DUAVEE® (DEW' ah-vee)
(conjugated estrogens/bazedoxifene)
Tablets

Read this Patient Information before you start taking DUAVEE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about DUAVEE?
  • Do not take additional estrogen products while you are taking DUAVEE.
  • Using estrogens may increase your chance of getting cancer of the uterus (womb).
  • Report any unusual vaginal bleeding right away while you are taking DUAVEE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogens to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
  • Using estrogens may increase your chances of getting strokes or blood clots.
  • Using estrogens may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.

What is DUAVEE?

DUAVEE is a prescription medicine that contains a mixture of estrogens and bazedoxifene.

What is DUAVEE used for?

DUAVEE is used after menopause for women with a uterus to:

You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.

DUAVEE is not for use in children.

It is not known if DUAVEE is safe and effective in people with kidney problems.

Who should not take DUAVEE?

Do not take DUAVEE if you:

What should I tell my healthcare provider before taking DUAVEE?

Before you take DUAVEE, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take other hormonal medicines, including progestins or other medicines like DUAVEE. Ask your healthcare provider if you do not know if you take any of these medicines.

Some medicines may affect how DUAVEE works. DUAVEE may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take DUAVEE?

  • nausea
  • vomiting
  • breast tenderness
  • dizziness
  • abdominal pain
  • feeling tired
  • vaginal bleeding

What are the possible side effects of DUAVEE?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious side effects include:

Call your healthcare provider right away if you get any of the following warning signs, or any other unusual symptoms that concern you:

Less serious, but common side effects include:

These are not all the possible side effects of DUAVEE. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with DUAVEE?

Ask your healthcare provider for ways to lower your chances of getting heart disease.

How do I store DUAVEE?

Keep DUAVEE and all other medicines out of the reach of children.

General information about the safe and effective use of DUAVEE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DUAVEE for a condition for which it was not prescribed. Do not give DUAVEE to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important information about DUAVEE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about DUAVEE that is written for health professionals.

For more information, go to www.DUAVEE.com, or call 1-800-438-1985.

What are the ingredients in DUAVEE?

Active Ingredients: conjugated estrogens and bazedoxifene. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components, including sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.

Inactive Ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, ascorbic acid, sucrose palmitic acid ester, hydroxyethylcellulose, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, isopropyl alcohol.

This Patient Information has been approved by the U.S. Food and Drug Administration.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0583-1.0
Revised October 2013

Revised: 11/2017
Document Id: 604ca3cf-0827-4ad7-94eb-e4d290f957c6
Set id: e1b75458-2e5b-46b9-92c6-fa6daba3770f
Version: 10
Effective Time: 20171108
 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.