When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to bicalutamide.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and take the next dose at your regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some medicines may affect how bicalutamide works. Tell your doctor if you are using any of the following:
  
  • Midazolam
  • Blood thinner (including warfarin)

Warnings While Using This Medicine:

• Tell your doctor if you have liver disease or diabetes.
• This medicine may cause the following problems:
  
  • Liver problems
  • Breast swelling and pain
  • Changes in blood sugar levels
• This medicine may make you drowsy or sleepy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Do not stop using this medicine without talking to your doctor.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, red or pink urine, difficult or painful urination
• Chest pain or trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Increased hunger or thirst, tiredness, blurred vision
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, tiredness, or weakness

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

• Back, pelvic, or bone pain
• Breast pain, swelling, or tenderness
• Constipation, diarrhea, nausea
• Dizziness
• Sweating, warmth or redness in your face, neck, arms, or upper chest
• Trouble getting an erection

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