What is the most important information I should know about BRUTRAX®?

BRUTRAX® may cause serious side effects including: heart disease. Women with early breast cancer, who have a history of blockage in their heart arteries (ischemic heart disease) and who take BRUTRAX®, may have an increase in symptoms of decreased blood flow to their heart compared to similar women who take tamoxifen.

Get medical help right away if you have new or worsening chest pain or shortness of breath during treatment with BRUTRAX®.

What is BRUTRAX®?

BRUTRAX® is a prescription medicine used in women after menopause (“the change of life”) for:
⇒   treatment of early breast cancer
         ♦   after surgery
         ♦   in women whose breast cancer is hormone receptor-positive
⇒   the first treatment of breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to        other parts of the body (metastatic), in women whose breast cancer is hormone receptor-positive or the hormone        receptors are not known.
⇒   treatment of advanced breast cancer, if the cancer has grown, or the disease has spread after tamoxifen therapy        BRUTRAX® does not work in women with
       breast cancer who have not gone through menopause (premenopausal women).

Who should not take BRUTRAX®?

Do not take BRUTRAX® if you:
•   Are pregnant or able to become pregnant. BRUTRAX® may harm your unborn baby. If you become pregnant while taking     BRUTRAX®, tell your doctor right away.
•   Have not gone through menopause (are premenopausal).
•   Have had severe allergic reaction to anastrozole or any of the ingredients in BRUTRAX®. See the end of this leaflet for a     complete list of ingredients in BRUTRAX®. Symptoms of a severe allergic reaction to BRUTRAX® include: swelling of the     face, lips, tongue or throat, trouble breathing or swallowing, hives and itching.

What should I tell my doctor before taking BRUTRAX®?

Before you take BRUTRAX®, tell your doctor if you:

• Have not gone through menopause. Talk to your doctor if you are not sure.
• Have or had a heart problem.
• Have been told you have bone thinning or weakness (osteoporosis)
• Have high cholesterol
• Have any other medical conditions
• Are pregnant or plan to become pregnant. BRUTRAX® may harm your unborn baby. See “who should not take BRUTRAX®?”
• Are breastfeeding or plan to breastfeed. It is not known if BRUTRAX® passes into breast milk. You and your doctor should decide if you will take BRUTRAX® or breastfeed. You should not do both.

• You should not take BRUTRAX® if you take tamoxifen. Taking BRUTRAX® with tamoxifen may lower the amount of BRUTRAX® in your blood and may cause BRUTRAX® not to work as well.
• Medicines that contain estrogen. BRUTRAX® may not work if taken with any of these medicines:
  •   hormone replacement therapy
  •   birth control pills
  •   estrogen creams
  •   vaginal rings
  •   vaginal suppositories

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take BRUTRAX®?

• Take BRUTRAX® exactly as your doctor tells you to take it.
• Continue taking BRUTRAX® until your doctor tells you to stop.
• BRUTRAX® can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next does, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.
• If you take too much BRUTRAX®, call your doctor or go to the nearest hospital emergency room right away.

If you take too much ARMIDEX, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of BRUTRAX?

BRUTRAX may cause serious side effects including:

• See “What is the most important information I should know about BRUTRAX?”
• bone thinning or weakness (osteoporosis). BRUTRAX lowers estrogen in your body, which may cause your bones to become thinner and weaker. This may increase your risk of fractures, especially of your spine, hip and wrist. Your doctor may order a bone mineral density test before you start and during treatment with BRUTRAX to check you for bone changes.
• increased blood cholesterol (fat in the blood). Your doctor may do blood tests to check your cholesterol while you are taking BRUTRAX.
• skin reactions. Stop taking BRUTRAX and call your doctor right away if you get any skin lesions, ulcers, or blisters.
• severe allergic reactions. Get medical help right away if you get:
  •   swelling of your face, lips, tongue, or throat
  •   trouble swallowing or breathing
• Stop taking BRUTRAX and call your doctor right away if you have any of these signs or symptoms of a liver problem:
  •   a general feeling of not being well
  •   yellowing of your skin or whites of your eyes
  •   pain on the right side of your stomach-area (abdomen)

Common side effects in women taking BRUTRAX include:

•   hot flashes
•   weakness
•   joint aches
•   joint pain, stiffness or swelling (arthritis)
•   pain
•   sore throat
•   high blood pressure
•   depression
•   nausea and vomiting
•   rash
•    back pain
•   sleep problems
•    bone pain
•    headache
•   swelling of your legs, ankles, or feet
•   increased cough
•   shortness of breath
•   build up of lymph fluid in the tissues of your affected arm (lymphedema)

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

These are not all the possible side effects of BRUTRAX. For more information, ask your doctor 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 BRUTRAX?

Store BRUTRAX at room temperature between 68°F to 77°F (20°C to 25°C).

Keep BRUTRAX and all medicines out of the reach of children.

General information about the safe and effective use of BRUTRAX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take BRUTRAX for a condition for which it was not prescribed. Do not give ARMIDEX to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about BRUTRAX that is written for health professionals. For more information call 1-866-992-9276 or go to www.BRUTRAX.com.

What are the ingredients in BRUTRAX?

Active ingredient: anastrozole

Inactive ingredients: lactose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

May/2013

Distributed by:

Taj Pharma India Brands
Taj Pharma Group (India)
P.O. Box No. 120002,
Azad Nagar Post office,
Andheri (w), Mumbai - 400 053.
India.
© Copyright 2019 Taj Pharmaceuticals Limited. All rights reserved.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 mg

BRUTRAX®

anastrozole tablets

1 mg tablets

Rx only

Taj Pharma India Brands
Taj Pharma Group (India)
P.O. Box No. 120002,
Azad Nagar Post office,
Andheri (w), Mumbai - 400 053.
India.

Note: This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world. The Price of the drugs indicated above may not match the actual price at which they are sold. Prices can change depending on many factors, including local taxes. These are only approximate indicative prices of the drug. The products discussed herein may have different product labelling in different countries. The product information provided in this site is intended only for the residents of India.

Information for Health Care Professionals
*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).