This medication is used to treat men with prostate cancer. Flutamide belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Flutamide works by blocking the effects of testosterone, thereby slowing the growth and spread of prostate cancer.

Read the Patient Information Leaflet if available from your pharmacist before you start using flutamide 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 3 times daily.

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

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop any medications for your prostate cancer unless told to do so by your doctor. Stopping your medications could allow the cancer to spread more rapidly.

Tell your doctor if your condition lasts or gets worse (such as urination becomes more difficult, bone pain increases).

See also Warning section.

Because flutamide is usually used with other medications, the side effects may be caused by the other medications or their combination. Hot flashes, loss of sexual interest/ability, diarrhea, nausea, vomiting, and enlargement of male breasts may occur. Less common side effects include drowsiness. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of dehydration. You may decrease dairy products, increase whole grains/vegetables/fruit, and stop any laxatives. Your doctor may prescribe anti-diarrhea medication (such as loperamide) to control your symptoms. Tell your doctor right away if you develop diarrhea that is severe or doesn't stop, or signs of dehydration (such as dizziness, decreased urination).

Flutamide may change the color of your urine to light orange-brown or yellow-green. This is not harmful.

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:

• mental/mood changes (such as depression, anxiety, nervousness)
• a breast lump
• confusion
• sudden severe tiredness
• weakness
• pale skin
• bluish fingernails/lips/skin
• fast heartbeat at rest
• feeling short of breath at rest

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.

Before taking flutamide, 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 problems
• a certain enzyme deficiency (glucose-6-phosphate dehydrogenase-G6PD)
• smoking
• hemoglobin M disease

This drug may rarely make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Older adults may be more sensitive to the side effects of this drug, especially drowsiness.

This medication is not usually used in women. It is unlikely to be used during pregnancy or breastfeeding. Women who are pregnant or breastfeeding should avoid touching or accidentally taking this medication.

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 of the products that may interact with this drug include:

• testosterone (patch, gel, injection)
• anabolic steroids (including over-the-counter androgens/anabolics/testosterone precursors)
• DHEA
• warfarin

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, blood PSA test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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.