Duavee®(conjugated estrogens/bazedoxifene)

• Do not take additional estrogen products while taking DUAVEE.
• Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
• Using estrogen-alone may increase your chances of getting strokes or blood clots.
• Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• These warnings are based on studies with estrogen-alone. The effects of DUAVEE compared to estrogen-alone are not known.

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

• To reduce moderate to severe hot flushes (hot flashes) due to menopause.
• To help reduce your chances of developing osteoporosis (thin, weak bones).

DUAVEE should be taken for the shortest time needed. You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.

• DUAVEE is not for use in children.
• The safety and effectiveness of DUAVEE in people with kidney problems is not known.

Do not take DUAVEE if you:

• have or have had blood clots
• are allergic to estrogens, bazedoxifene, or any of the ingredients in DUAVEE
• have unusual vaginal bleeding
• currently have or have had certain cancers (estrogen may increase the chance of getting certain types of cancers, including cancer of the breast or uterus)
• currently have or have had liver problems
• have been diagnosed with a bleeding disorder
• are pregnant or think you may be pregnant

Before taking DUAVEE, tell your healthcare provider if you:

• have any unusual vaginal bleeding
• have any other medical conditions including asthma, epilepsy (seizures), diabetes, migraine headaches, endometriosis, lupus, angioedema (swelling of the face, lips, tongue, throat), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood
• are going to have surgery or will be on bed rest
• are breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how DUAVEE works. DUAVEE may also affect how your other medicines work.

Especially tell your healthcare provider if you take other hormonal medicines, including progestins, estrogens, or estrogen agonist/antagonists.

• Take DUAVEE exactly as your healthcare provider tells you to take it.
• Take one tablet at the same time each day.
• Swallow the tablet whole.
• DUAVEE can be taken with or without food.
• Remove DUAVEE from the blister package immediately before you take it. Do not place in pill boxes or pill organizers.
• If you miss a dose of DUAVEE, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If your healthcare provider has told you to also take calcium and vitamin D, you can take DUAVEE at the same time.
• If you take too much DUAVEE, call your healthcare provider. Symptoms of overdose include nausea, vomiting, breast tenderness, dizziness, abdominal pain, fatigue, and vaginal bleeding.

DUAVEE may cause serious side effects, including:

• Blood clots
• Stroke
• Heart attack
• Cancer of the lining of the uterus (endometrial cancer)
• Cancer of the breast
• Cancer of the ovaries
• Dementia
• Gallbladder problems
• Loss of vision - Discontinue DUAVEE and get medical care if you have sudden partial or complete loss of vision
• High blood pressure
• High levels of fat (triglycerides) in your blood
• Liver problems
• Thyroid problems
• Fluid retention
• Low calcium levels (hypocalcemia)
• Swelling of the mouth or tongue
• Worsening of other medical conditions such as asthma, diabetes, epilepsy, migraine, porphyria, lupus, and liver hemangiomas

Call your healthcare provider right away if you get any of the following warning signs:

• new breast lumps
• unusual vaginal bleeding
• changes in vision or speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

The most common side effects of DUAVEE include:

• muscle spasms
• nausea
• diarrhea
• upset stomach
• abdominal pain
• throat pain
• dizziness
• neck pain

These are not all the possible side effects of DUAVEE. Call your doctor for medical advice about side effects.

• Talk with your healthcare provider regularly about whether you should continue taking DUAVEE.
• See your healthcare provider right away if you get vaginal bleeding while taking DUAVEE.
• Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

• Store DUAVEE at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep DUAVEE in its blister packaging until you are ready to take it. Do not place DUAVEE in pill boxes or pill organizers.
• After opening the foil pouch, use DUAVEE within 60 days.
• Keep DUAVEE and all medicines out of the reach of children and away from people who should not take it.

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.

Active ingredients: conjugated estrogens (a mixture of sodium estrone sulfate, sodium equilin sulfate, and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin) and bazedoxifene 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, iron oxides (red, yellow, black), povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, isopropyl alcohol