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HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Raloxifene may rarely cause serious blood clots, especially in the legs or lungs. Women who have or had blood clots (including in the legs, lungs, or eyes) should not take raloxifene. Also, women who have had a heart attack or are at risk for a heart attack may rarely have an increased risk of dying from a stroke while taking raloxifene. Before starting treatment with raloxifene, tell your doctor if you have or had blood clots in your legs/lungs/eyes, a stroke, mini-stroke (TIA), heart disease, heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, or if you smoke. Discuss these risks and the benefits of using raloxifene with your doctor.
Raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. It slows down bone loss and helps to keep bones strong, making them less likely to break. Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive breast cancer) after menopause. Raloxifene is not an estrogen hormone, but it acts like estrogen in some parts of the body, like your bones. In other parts of the body (uterus and breasts), raloxifene acts like an estrogen blocker. It does not relieve menopause symptoms such as hot flashes. Raloxifene belongs to a class of drugs known as selective estrogen receptor modulators-SERMs. This medication should not be used before menopause. It should not be used to prevent heart disease.
Read the Medication Guide provided by your pharmacist before you start taking raloxifene 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. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Be sure to get enough calcium and vitamin D in your diet. Consult your doctor or pharmacist to see if you need to take calcium and vitamin D supplements. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
Hot flashes or leg cramps may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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.
Get medical help right away if you have any very serious side effects, including: signs of a blood clot (such as sudden pain/swelling/redness/warmth in the leg or arm, chest pain, trouble breathing, coughing up blood, sudden vision changes like blurred vision/loss of vision), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
A very serious allergic reaction to this drug 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.
See also Warning section. Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, 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: blood clots (including in the legs/lungs/eyes), stroke, mini-stroke (TIA), heart disease (blocked blood vessels in the heart), heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, smoking, kidney disease, liver disease, heart failure, cancer, high blood fat (triglyceride) levels caused by estrogen treatment.
Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using raloxifene. You may need to stop this medication for a time or take special precautions. This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
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: bile acid-binding resins (such as cholestyramine, colestipol), estrogens. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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: dizziness, vomiting.
Do not share this medication with others. Lab and/or medical tests (such as bone density tests, X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. You should have regular complete physical exams (for example, once a year) which include breast and pelvic exams, and Pap smear. You should also have periodic mammograms as determined by your doctor.
Follow your doctor’s instructions for examining your own breasts. Report any unusual vaginal bleeding, breast pain, or lumps right away. 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. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.
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.
Store at room temperature away from light and moisture. Do not store in the bathroom. 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.
RALOXIFENE – ORAL