Conjugated Estrogens; Bazedoxifene Tablets

What is this medication?

CONJUGATED ESTROGENS; BAZEDOXIFENE (CON ju gate ed ESS troe jenz; BAY ze DOX i feen) reduces the number and severity of hot flashes due to menopause. It may be used to prevent osteoporosis after menopause. It works by increasing levels of the hormone estrogen in your body, which decreases the symptoms of menopause. It also prevents the lining of the uterus from becoming too thick, which decreases the risk of cancer of the uterus.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DUAVEE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Dementia
• Diabetes
• Endometriosis
• Fibroids
• Gallbladder disease
• Heart disease or recent heart attack
• Hereditary angioedema
• High blood pressure
• High cholesterol
• High level of calcium in the blood
• Kidney disease
• Liver disease
• Mental depression
• Migraine headaches
• Porphyria
• Protein C deficiency
• Protein S deficiency
• Seizure disorder
• Stroke
• Systemic lupus erythematosus
• Thyroid disorder
• Tobacco smoker
• An unusual or allergic reaction to estrogens, bazedoxifene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your medication at regular intervals, at the same time each day. Do not take your medication more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• Metyrapone

This medication may also interact with the following:

• Barbiturates, such as phenobarbital
• Carbamazepine
• Clarithromycin
• Erythromycin
• Grapefruit juice
• Medications for fungal infections like ketoconazole and itraconazole
• Phenytoin
• Rifampin
• Ritonavir
• St. John's Wort
• Thyroid hormones

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Do not take a progestin product or additional estrogen or estrogen-like products while taking this medication. Discuss the risks and benefits of taking this medication with your care team.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow his or her guidelines for these tests.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

You should make sure you get enough calcium and vitamin D in your diet while you are taking this medication. Discuss your dietary needs with your care team.

Exercise may help to prevent bone loss. Discuss your exercise needs with your care team.

This medication can rarely cause blood clots. You should avoid long periods of bed rest while taking this medication. If you are going to have surgery, tell your care team that you are taking this medication. This medication should be stopped at least 3 days before surgery. After surgery, it should be restarted only after you are walking again. It should not be restarted while you still need long periods of bed rest.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you have any reason to think you are pregnant; stop taking this medication at once and contact your care team.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Muscle spasms
• Nausea
• Sore throat
• Swelling of the ankles, hands, or feet
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.