Uses

This medication is a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). It is used by women with a uterus to help reduce symptoms of menopause (such as hot flashes, vaginal dryness) and to prevent bone loss (osteoporosis) after menopause. Conjugated estrogens are female hormones which help to decrease menopausal symptoms caused by the body making less estrogen. Bazedoxifene is not a hormone, but works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. The bazedoxifene in this medication helps to preserve bone mass and reduces the risk of cancer of the uterus which can be caused by using estrogen.

If you are using this medication to treat symptoms only in and around the vagina, consider using products applied directly inside the vagina instead of medications that are taken by mouth, absorbed through the skin, or injected.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. You may take it with food or right after a meal to prevent stomach upset. Swallow the tablet whole. Do not chew or crush. Doing so can release all of the drug at once, increasing the risk of side effects. Also do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or take this medication more often or for a longer time than directed.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• lumps in the breast
• mental/mood changes (such as depression, memory loss)
• persistent nausea/vomiting
• severe stomach/abdominal pain
• yellowing eyes/skin
• dark urine
• swelling hands/ankles/feet
• increased thirst/urination
• unusual vaginal bleeding (such as spotting, sudden heavy bleeding)

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including:

• chest/jaw/left arm pain
• confusion
• coughing up blood
• pain/swelling/warmth in the groin/calf
• trouble speaking
• sudden dizziness/fainting
• sudden/severe headache
• sudden vision changes (such as partial/complete blindness)
• tingling/weakness/numbness in the arms/legs
• trouble breathing
• unusual sweating
• weakness on one side of the body

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to conjugated estrogens or bazedoxifene; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• vaginal bleeding of unknown cause
• diabetes
• cancer (especially breast cancer, cancer of the uterus/ovaries)
• blood clots
• blood clotting disorders (such as protein C or protein S deficiency)
• family medical history (especially of breast lumps, cancer, blood clots)
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder disease
• heart disease (such as irregular heartbeat, previous heart attack)
• high blood pressure
• high cholesterol/triglyceride levels
• kidney disease
• liver disease
• lupus
• mental/mood disorders (such as dementia, depression)
• migraine headaches
• underactive thyroid (hypothyroidism)
• mineral imbalance (low or high level of calcium in the blood)
• obesity
• a certain hormone problem (hypoparathyroidism)
• uterus problems (such as fibroids, endometriosis)
• asthma
• seizures
• stroke
• a certain blood disorder (porphyria)

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

Estrogens pass into breast milk and may reduce the quality and amount of breast milk produced. It is unknown if bazedoxifene passes into breast milk. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• other estrogen agonist/antagonists (such as ospemifene, raloxifene)
• fulvestrant
• tamoxifen
• tranexamic acid

This medication may interfere with certain laboratory tests (including metyrapone test, blood clotting tests, thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.

Notes

Do not share this medication with others.

Keep all regular medical and laboratory appointments. You should have regular complete physical exams (for example, once a year) which include laboratory and medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, pap smear) to monitor your progress and check for side effects. Follow your doctor's instructions for examining your own breasts, and report any lumps right away. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.

Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. After opening the foil pouch, use the US product within 60 days and the Canadian product within 45 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.