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FLUTAMIDE capsule


  1. Patient Information
  2. What Is Flutamide Therapy?
  3. Who Should Not Take The Flutamide Product?
  4. Are There Important Risks I Should Know About Flutamide Therapy?
  5. How Should I Take Flutamide Capsules?
  6. Can I Take Other Medicines?
  7. What Are The Other Possible Side Effects Of Taking Flutamide Capsules?
  8. Are There Any Other Lab Tests My Doctor Will Be Performing?
  9. Manufactured By:
  10. Important Information For Patients Taking Flutamide Capsules:
  11. What Is Flutamide Therapy?
  12. Who Should Not Take The Flutamide Product?
  13. Are There Important Risks I Should Know About Flutamide Therapy?
  14. A Recommended Schedule For These Blood Tests Is:
  15. In Addition, You Shouldcall Your Doctor Right Away If You Have Any Of The Following Signs Or Symptoms:
  16. How Should I Take Flutamide Capsules?
  17. If You Experience Moderate Diarrhea Due To Flutamide Capsules, The Following Advice May Help:
  18. Manufactured By:
  19. Distributed By:

Patient Information 

Important information for patients taking flutamide capsules.

Read this information carefully each time your prescription is refilled because there may be new information available. This summary does not tell you everything you need to know about flutamide therapy. Your doctor is the best source of information about your treatment. Ask your doctor about questions you have.

What Is Flutamide Therapy? 

Flutamide capsules, in combination with other therapies, is a treatment option for men with some types of prostate cancer.

Prostate cancer results from the abnormal growth of prostate cells. Medical scientists do not know exactly what causes the abnormal cells, but age, environment, and genetics are important factors. Male hormones ( androgens ) cause the cancer to grow. The cancer growth can be slowed down by blocking the effect of androgens.

The flutamide product is used together with an injection called LHRH agonist, as a combined treatment called total androgen blockade. The goal of this treatment is to reduce androgen levels and to block the effect of androgen on the tumor. The LHRH agonist reduces androgen levels. Flutamide therapy blocks the effect of androgen on the tumor.

Who Should Not Take The Flutamide Product? 

You should not take flutamide capsules if you have liver problems or if you are allergic to it. Flutamide capsules are for useonlyin men, therefore women should not take flutamide capsules.

Are There Important Risks I Should Know About Flutamide Therapy? 

Some men taking the flutamide product had liver injury and needed to be hospitalized. In rare cases, men died because of liver failure while they were taking flutamide capsules. In about half of these cases, the liver failure occurred in the first 3 months that they were taking flutamide capsules.

Because the flutamide product may cause liver failure,it is very important that you have all blood tests recommended by your doctor. These tests help identify whether you are having liver problems. A recommended schedule for these blood tests is:

  • Before starting flutamide treatment.
  • Every month for the first 4 months of therapy.
  • Periodically after the first 4 months.

How Should I Take Flutamide Capsules? 

Take your flutamide capsules as your doctor has prescribed. The usual dosing is 2 capsules every 8 hours.

Your doctor will determine whether flutamide therapy is right for you based on many different factors. These include how large your tumor is, how far it has spread and your physical condition. In addition to flutamide capsules, you may be getting other treatments, including regular injections of LHRH agonist or radiation therapy. Do not stop or interrupt any treatment without consulting your healthcare professional.

If you miss a dose of flutamide capsules, simply continue therapy with your next scheduled dose. Do not try to make up for it by taking extra capsules.

Can I Take Other Medicines? 

If you are taking any other medicines, especially warfarin (a blood-thinning drug), tell your doctor before beginning flutamide therapy.

What Are The Other Possible Side Effects Of Taking Flutamide Capsules? 

In a medical study, when flutamide capsules were taken together with an LHRH agonist, the most common side effects were hot flashes, loss of sex drive (libido) and impotence. In addition, some men had diarrhea, nausea or vomiting, and breast enlargement.

In another medical study, when the flutamide product was taken together with goserelin acetate (an LHRH agonist) and radiation therapy, the side effects of flutamide therapy were about the same as when radiation therapy was given alone. These included hot flashes, diarrhea, nausea and skin rash.

Are There Any Other Lab Tests My Doctor Will Be Performing? 

Your doctor may perform other regular tests (such as the PSA blood test) to ensure that your body is responding to treatment. Ask your doctor if you have any questions about how your flutamide therapy is being monitored.

Please ask your doctor about any questions concerning prostate cancer or flutamide therapy, or you can also ask for a more detailed leaflet that is written for healthcare professionals.

Manufactured By: 

PAR PHARMACEUTICAL

Chestnut Ridge, NY 10977

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Important Information For Patients Taking Flutamide Capsules: 

Read this information carefully each time your prescription is refilled because there may be new information available. This summary does not tell you everything you need to know about flutamide therapy. Your doctor is the best source of information about your treatment. Ask your doctor about questions you have.

What Is Flutamide Therapy? 

Flutamide, in combination with other therapies, is a treatment option for men with some types of prostate cancer.

Prostate cancer results from the abnormal growth of prostate cells. Medical scientists do not know exactly what causes the abnormal cells, but age, environment, and genetics are important factors. Male hormones ( androgens ) cause the cancer to grow. The cancer growth can be slowed down by blocking the effect of androgens.

The flutamide product is used together with an injection called LHRH agonist , as a combined treatment called total androgen blockade . The goal of this treatment is to reduce androgen levels and to block the effect of androgen on the tumor. The LHRH agonist reduces androgen levels. Flutamide therapy blocks the effect of androgen on the tumor.

Who Should Not Take The Flutamide Product? 

You should not take flutamide if you have liver problems or if you are allergic to it. Flutamide capsules are for useonlyin men, therefore women should not take flutamide capsules.

Are There Important Risks I Should Know About Flutamide Therapy? 

Some men taking the flutamide product had liver injury and needed to be hospitalized. In rare cases, men died because of liver failure while they were taking flutamide. In about half of these cases, the liver failure occurred in the first 3 months that they were taking flutamide.

Because the flutamide product may cause liver failure,it is very important that you have all blood tests recommended by your doctor.These tests help identify whether you are having liver problems.

A Recommended Schedule For These Blood Tests Is: 

  • before starting flutamide treatment.
  • every month for the first 4 months of therapy.
  • periodically after the first 4 months.

In Addition, You Shouldcall Your Doctor Right Away If You Have Any Of The Following Signs Or Symptoms: 

  • loss of appetite.
  • nausea and vomiting.
  • stomach or abdominal pain.
  • fatigue (feeling extremely tired).
  • flu-like symptoms (muscle aches, soreness).
  • brown urine.
  • jaundice (yellowing of the skin or whites of the eyes).

These may be signs of liver failure.

How Should I Take Flutamide Capsules? 

Take your flutamide capsules as your doctor has prescribed. The usual dosing is 2 capsules every 8 hours.

Your doctor will determine whether flutamide therapy is right for you based on many different factors. These include how large your tumor is, how far it has spread, and your physical condition. In addition to flutamide, you may be getting other treatments, including regular injections of LHRH agonist or radiation therapy.

Do not stop or interrupt any treatment without consulting your healthcare professional.

If you miss a dose of flutamide capsules, simply continue therapy with your next scheduled dose. Do not try to make up for it by taking extra capsules.

If You Experience Moderate Diarrhea Due To Flutamide Capsules, The Following Advice May Help: 

  • drink plenty of fluids.
  • reduce your intake of dairy products (for example, milk, cheese, yogurt).
  • increase your intake of whole grains, fruits, and vegetables.
  • stop laxative use.
  • take nonprescription antidiarrheal medicines.

If your diarrhea continues or it becomes severe, contact your doctor right away.

Manufactured By: 


Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed By: 


Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: July 2014 195814-2



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