Conjugated Estrogens, Bazedoxifene Oral tablet

What is this medicine?

CONJUGATED ESTROGENS; BAZEDOXIFENE (CON ju gate ed ESS troe jenz; BAY ze DOX i feen) is used as hormone replacement in menopausal women who still have their uterus. This medicine helps to treat hot flashes and prevent osteoporosis (weak bones).

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

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals, at the same time each day. Do not take your medicine 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 pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've 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 medicine?

• aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

• metyrapone

This medicine may also interact with the following medications:

• barbiturates, such as phenobarbital

• carbamazepine

• clarithromycin

• erythromycin

• grapefruit juice

• medicines 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 medicine?

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

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

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional 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 medicine. Discuss your dietary needs with your health care professional or nutritionist.

Exercise may help to prevent bone loss. Discuss your exercise needs with your doctor or health care professional.

This medicine can rarely cause blood clots. You should avoid long periods of bed rest while taking this medicine. If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine. This medicine 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 medicine, 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 medicine at once and contact your doctor or health care professional.

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 medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast tissue changes or discharge

• changes in vision

• chest pain

• confusion, trouble speaking or understanding

• dark urine

• general ill feeling or flu-like symptoms

• light-colored stools

• nausea, vomiting

• pain, swelling, warmth in the leg

• right upper belly pain

• severe headaches

• shortness of breath

• sudden numbness or weakness of the face, arm or leg

• trouble walking, dizziness, loss of balance or coordination

• unusual vaginal bleeding

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• abdominal pain

• diarrhea

• dizziness

• hair loss

• increased hunger or thirst

• increased urination

• nausea

• symptoms of vaginal infection like itching, irritation or unusual discharge

• unusually weak or tired

• 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 medicine?

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 medicine 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.