Medguide

Patient Information
Bicalutamide Tablets, USP
[pronounced bi-cal-oo-ta-mide]

Read the Patient Information that comes with Bicalutamide Tablets, USP before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What are Bicalutamide Tablets, USP?

Bicalutamide Tablets, USP are a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Bicalutamide Tablets, USP are safe and effective in children.

Who should not take Bicalutamide Tablets, USP?

Do not take Bicalutamide Tablets, USP if:

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you are a woman.

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you are allergic to any of the ingredients in Bicalutamide Tablets, USP. See the end of this leaflet for a complete list of ingredients.

What should I tell my healthcare provider before taking Bicalutamide Tablets, USP?

Before you take Bicalutamide Tablets, USP, tell your healthcare provider about all your medical conditions including if you:

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are a woman (see who should not take Bicalutamide Tablets, USP).

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are pregnant or think you may be pregnant.

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have liver problems.

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take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.

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have diabetes (poor blood sugar control has been reported in people taking Bicalutamide Tablets, USP in combination with LHRH medicines).

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Bicalutamide Tablets, USP and other medicines may affect each other causing side effects. Bicalutamide Tablets, USP may affect the way other medicines work, and other medicines may affect how Bicalutamide Tablets, USP work.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Bicalutamide Tablets, USP?

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Take Bicalutamide Tablets, USP exactly as prescribed.

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Take Bicalutamide Tablets, USP at the same time everyday.

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Your treatment with Bicalutamide Tablets, USP should start at the same time as your treatment with the LHRH medicine.

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If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.

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Bicalutamide Tablets, USP can be taken with or without food.

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If you take too much Bicalutamide Tablets, USP, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.

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Do not stop taking Bicalutamide Tablets, USP unless your healthcare provider tells you.

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Your healthcare provider may do blood tests while you take Bicalutamide Tablets, USP.

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Your prostate cancer may get worse while taking Bicalutamide Tablets, USP in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Bicalutamide Tablets, USP?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Bicalutamide Tablets, USP affect you.

What are the possible side effects of Bicalutamide Tablets, USP?

Bicalutamide Tablets, USP can cause serious side effects.

Get medical help right away, if you have:

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Trouble breathing with or without a cough or fever. Some people who take Bicalutamide Tablets, USP get an inflammation in the lungs called interstitial lung disease.

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An allergic reaction. Symptoms of an allergic reaction include: itching of the skin, hives (raised bumps), swelling of the face, lips, tongue, throat, or trouble swallowing.

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Yellowing of the skin and eyes (jaundice), dark urine, right upper stomach pain, nausea, vomiting, tiredness, loss of appetite, chills, fever, whole body pain. These may be symptoms of liver damage.

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Poor blood sugar control can happen in people who take Bicalutamide Tablets, USP in combination with LHRH medicines.

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Enlargement of breast (gynecomastia) and breast pain.

The most common side effects of Bicalutamide Tablets, USP include:

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hot flashes, or short periods of feeling warm and sweating

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whole body pain in your back, pelvis, stomach

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feeling weak

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constipation

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infection

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nausea

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swelling in your ankles, legs or feet

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diarrhea

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blood in your urine

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waking from sleep to urinate at night

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a decrease in red blood cells (anemia)

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feeling dizzy

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Bicalutamide Tablets, USP. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE BICALUTAMIDE TABLETS, USP?

Store Bicalutamide Tablets, USP between 20°C to 25°C (68°F to 77°F).

Keep Bicalutamide Tablets, USP and all medicines out of the reach of children.

General information about the safe and effective use of Bicalutamide Tablets, USP.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Bicalutamide Tablets, USP for a condition for which it was not prescribed. Do not give Bicalutamide Tablets, USP to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Bicalutamide Tablets, USP. If you would like more information about Bicalutamide Tablets, USP talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Bicalutamide Tablets, USP that is written for health professionals. For more information call 1-800-367-3395.

What are the ingredients in Bicalutamide Tablets, USP?

Active ingredients include: bicalutamide.

Inactive ingredients include: lactose monohydrate, magnesium stearate, povidone, crospovidone, sodium lauryl sulfate, polyethylene glycol, hypromellose, titanium dioxide.

Manufactured for:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Synthon Hispania S.L.
Barcelona, Spain
Made in Spain

Marketed/Packaged by:
GSMS, Inc.
Camarillo, CA 93012Revised: 11/2010

PPI-5011-0