Bicalutamide Oral Tablet (BICALUTAMIDE - ORAL)

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

It is very important that you follow your doctor's instructions for all blood tests.

Cautions

This medicine is not approved for use by women.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

If you drink alcohol regularly, please speak with your doctor.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

This medicine may damage sperm. Men should use reliable birth control while taking this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Call your doctor right away if you notice slow or shallow breathing.

Call your doctor right away if you notice any unusual bleeding or bruising.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• decreased appetite
• breast pain or swelling
• constipation or diarrhea
• dizziness or drowsiness
• feeling of heat or flushing
• hair loss
• high blood sugar
• increased risk for an infection
• nausea and vomiting
• stomach upset or abdominal pain
• increased urinary frequency
• urinary tract infections
• waking up at night to urinate
• difficulty or discomfort urinating
• weakness
• weight loss

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• back pain
• unusual bruising or discoloration on skin
• chest pain
• changes in memory, mood, or thinking
• swelling of the legs, feet, and hands
• fever or chills
• numbness or tingling in hands and feet
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• problems with sexual functions or desire
• shortness of breath
• light colored stool
• blood in urine
• blurring or changes of vision
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.