This medicine is an anti-estrogen used to treat breast cancer that has spread to other sites in the body. It is also used along with other medicines to treat other types of breast cancer. It is used in women who are at high risk for breast cancer and in women with ductal carcinoma in situ (DCIS) (after surgery and radiation) to decrease the risk of developing breast cancer. It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE MAY BE TAKEN on an empty stomach or with food. Take this medicine with water or another nonalcoholic liquid. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. Do not take tablets after the expiration date printed on the label. KEEP THIS MEDICINE out of the reach of children and away from pets. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: Women taking this medicine to decrease the risk of developing breast cancer have developed cancer of the uterus, stroke, and blood clots in the lung. Some of these events have been fatal. Contact your doctor right away if you develop symptoms such as unusual vaginal bleeding or discharge; abnormal menstrual period; groin pressure or pain; chest pain; shortness of breath; coughing up blood; confusion; one-sided weakness; vision problems; or slurred speech. WOMEN AT HIGH RISK of breast cancer or with DCIS should discuss the use of this medicine with their doctor. Decide if the possible benefits (reducing the risk of breast cancer) outweigh the risk of these events. The benefits of this medicine outweigh the risks in women who already have breast cancer. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking anastrazole. DO NOT TAKE THIS MEDICINE if you are using this medicine to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), aromatase inhibitors (eg, letrozole), bupropion, cinacalcet, clobazam, cytotoxic cancer medicines (eg, cisplatin), duloxetine, fluoxetine, fluorouracil, mitomycin C, paroxetine, perphenazine, pimozide, quinidine, rifampin, sertraline, terbinafine, thioridazine, or ticlopidine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including high blood calcium levels, a weakened immune system, low white blood cell levels, low blood platelet levels, high cholesterol or lipid levels, cataracts or other vision problems, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of blood clots in the legs or lungs or if you are confined to a bed or chair. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are using this medicine to reduce your risk of breast cancer and you have a history of blood clots in the lungs or legs. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may while taking this medicine include bone pain; cough; dizziness; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal menstrual periods; calf or leg pain, swelling, redness, or tenderness; chest pain; confusion; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; increased or painful urination; loss of balance or coordination; missed menstrual period; new or unusual breast lumps or pain; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent loss of appetite, nausea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; skin changes; slurred speech; sudden severe headache; swelling of the arms or the legs; symptoms of high blood calcium levels (eg, change in the amount of urine produced; increased thirst; irregular heartbeat; mental or mood changes; muscle aches or weakness; severe or persistent constipation or vomiting); unusual bleeding or bruising; unusual vaginal bleeding or bloody discharge; vision problems; or yellowing of the eyes or skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include exaggerated reflexes, seizures, severe or persistent dizziness, tremor, trouble breathing, or trouble walking.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.