FLUTAMIDE

Rarely, flutamide has caused severe (sometimes fatal) liver problems. Immediately tell your doctor if you develop symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting, persistent stomach/abdominal pain, severe tiredness, dark urine, yellowing eyes/skin, aching muscles, joint pain). Liver problems can happen at any time while taking flutamide, but they occur most often during the first 3 months of treatment. Your doctor will tell you whether to stop or continue flutamide. Your doctor will monitor your liver function with blood tests while you take flutamide. Keep all medical and laboratory appointments. Avoid alcohol while taking flutamide.

Pregnancy Risk: Category D (Positive evidence of risk)

You should check with your doctor immediately if any of these side effects occur when taking flutamide:

More common

• Black, tarry stools
• bloody or cloudy urine
• continuing diarrhea
• continuing stomach pain
• difficult, burning, or painful urination
• frequent urge to urinate
• pale skin
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blurred vision
• chest pain
• chills
• cough
• difficulty with breathing
• dizziness
• drowsiness
• fever
• headache
• nervousness
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling
• swollen glands

If any of the following symptoms of overdose occur while taking flutamide, get emergency help immediately:

Symptoms of overdose

• Goosebumps
• shakiness and unsteady walk
• tearing of the eyes
• unsteadiness, trembling, or other problems with muscle control or coordination
• weight loss

Some of the side effects that can occur with flutamide may not need medical attention:

More common

• Decreased interest in sexual intercourse
• diarrhea
• feeling of warmth
• inability to have or keep an erection
• indigestion
• loss in sexual ability, desire, drive, or performance
• passing of gas
• redness of the face, neck, arms and occasionally, upper chest
• stomach pain, fullness, or discomfort
• sudden sweating
• swelling of the breasts or breast soreness in both females and males

Less common

• Depression
• drowsiness
• fear or nervousness

mood or mental changes

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Women who are pregnant or breastfeeding should avoid touching or accidentally taking this medication.

Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function tests, blood PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 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.

Brands

Available Brands

Flutanon [ Croma Medic ]

Also marketed as

Fugerel [ Schering-Plough ]