When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to nilutamide. Check with your doctor before taking nilutamide if you have liver disease or severe breathing problems.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to take and how often. Take this medicine exactly as your doctor ordered.
• Nilutamide is given as part of a treatment for prostate cancer that includes surgery. Your doctor may want you to start taking this medicine on the day of your surgery or the day after surgery.
• You may take the medicine with food or on an empty stomach.
• Do not stop taking this medicine or skip any doses unless you have talked with your doctor.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are taking phenytoin (Dilantin®), theophylline (Theo-Dur®, Slo-Bid®, and others), or Coumadin®.
• Alcohol taken with nilutamide can cause dizziness, low blood pressure, or facial flushing. If you have these reactions, avoid drinking alcohol while taking this medicine.

Warnings While Using This Medicine:

• This medicine may cause liver damage. Signs of liver problems are yellowing of your skin or the whites of your eyes, dark brown or amber-colored urine, stomach pain (especially on the right upper side of your stomach), nausea, and vomiting. If you have these symptoms, call your doctor right away.
• Some patients taking this medicine developed pneumonia. If you have trouble breathing or a breathing problem that gets worse, a cough, fever, or chest pain, call your doctor right away.
• This medicine may make it harder for your eyes to adjust from light to dark. If you are driving at night or through tunnels, wearing sunglasses or tinted lenses may help.
• Females who are pregnant or breastfeeding should talk to their doctor before taking this medicine.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Yellowing of skin and eyes
• Dark or amber-colored urine
• Extreme tiredness
• Nausea, vomiting, stomach pain
• Trouble breathing
• Cough, fever, chest pain

If you notice these less serious side effects, talk with your doctor:

• Stomach upset, appetite loss
• Constipation
• Swollen breasts
• Dizziness
• 'Hot flushes' (redness in your face, warmth, and sweating)
• Trouble seeing in the dark or other changes in your eyesight

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088