Bicalutamide tablets

What is this medicine?

BICALUTAMIDE (bye ka LOO ta mide) blocks the effect of the male hormone testosterone on the prostate. This medicine is used to treat advanced prostate cancer in men. It is given with other treatments.

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What should I tell my health care provider before I take this medicine?

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They need to know if you have any of these conditions:
-if you are female (this medicine is not for use in women)
-liver disease
-an unusual or allergic reaction to bicalutamide, other medicines, foods, dyes, or preservatives

How should I use this medicine?

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Take this medicine by mouth with a glass of water. You may take it with or without food. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

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If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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-warfarin

What should I watch for while using this medicine?

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Visit your doctor or health care professional for regular checks on your progress. You may need regular tests to make sure your liver is working properly.

This medicine should not be used in women. Serious side effects to an unborn child are possible. Talk to your doctor or pharmacist for more information.

What side effects may I notice from receiving this medicine?

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Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-blood in the urine
-breathing problems
-chest pain
-dark urine
-severe nausea and vomiting
-yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
-diarrhea
-hot flashes
-loss of appetite
-nausea
-weak or tired

Where should I keep my medicine?

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Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Information on use before, during and after pregnancy.

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FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.