IMPORTANT: 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.

ANASTROZOLE – ORAL

(an-AS-TROE-zole)

COMMON BRAND NAME(S): Arimidex

USES: This medication is used to treat breast cancer in women who have gone through “the change of life” (menopause). Anastrozole works by lowering estrogen hormone levels to help shrink tumors and slow their growth.

HOW TO USE: Take this medication by mouth with or without food, usually once a day, or as directed by your doctor.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster and the risk of serious side effects may be increased.

Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle or break the tablets of this medication.

SIDE EFFECTS: Constipation, diarrhea, nausea, vomiting, upset stomach, loss of appetite, body aches and pains, breast swelling/tenderness/pain, headache, dry mouth, scratchy throat, increased cough, dizziness, trouble sleeping, tiredness/weakness, flushing and sweating (hot flashes/hot flushes), vaginal bleeding, hair thinning, and weight change can occur. Changes in diet such as eating several small meals may help lessen the chance of nausea and vomiting. If any of these effects persist or worsen, notify 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression), excessive thirst, numbness/tingling/swelling of the hands or feet, unusual tickling feeling, persistent cough, unusual vaginal discharge/burning/itching/odor, unusually stiff muscles, muscle pain, joint stiffness/pain, pain/redness/swelling of the arms or legs, vision changes, bone pain, bone fracture, signs of infection (e.g., fever, chills, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, trouble breathing, confusion, fainting, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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 anastrozole, 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: liver disease, high blood pressure, heart disease (such as ischemic heart disease, history of chest pain), brittle bone disease (osteoporosis), blood clots.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Anastrozole is used mainly in women after menopause. If you have not gone through menopause and your doctor has prescribed this for you, this medication must not be used during pregnancy. It may cause harm to an unborn baby or miscarriage. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of childbearing age should use reliable form(s) of contraception (such as latex condoms) during treatment. Products containing estrogen (such as birth control pills) should not be used. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: estrogens, tamoxifen.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting anastrozole.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., cholesterol levels, liver function tests, bone density tests) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

This medication may increase your risk of osteoporosis. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and/or a bisphosphonate medications (such as risedronate). Discuss lifestyle changes that might benefit you.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture.

Store the Canadian product at room temperature 59-86 degrees F (15-30 degrees C) away from light and moisture.

Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.