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Conj Estrogens-Bazedoxifene

Warning

Women taking this product should not take additional estrogens, progestins, or additional estrogen agonist/antagonists (see also Drug Interactions section).

Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.

Estrogens can increase the risk of cancer of the uterus (endometrial cancer). The bazedoxifene in this product may help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.

In postmenopausal women, estrogens, taken with or without a progestin, increase the risk of cancer of the breast/ovaries, stroke, dementia, and serious blood clots. When used along with a progestin, estrogens also increase the risk of heart disease (such as heart attacks).

The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. This medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to take this medication. If you will be taking this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

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 medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects last or get worse, 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: nausea/vomiting that doesn't stop, lumps in the breast, mental/mood changes (such as depression, memory loss), 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.

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