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ANASTROZOLE tablet


  1. Anastrozole Tablets Are A Prescription Medicine Used In Women After Menopause ("the Change Of Life") For:
  2. Do Not Take Anastrozole Tablet If You:
  3. Before You Take Anastrozole Tablets, Tell Your Healthcare Provider If You:
  4. How Should I Take Anastrozole Tablets?
  5. Anastrozole Tablets May Cause Serious Side Effects Including:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Manufactured For:
  9. Patient Information
  10. Anastrozole Tablets Are Prescription Medicine Used In Women Who Have Finished Menopause ( The Change Of Life ) For:
  11. Who Should Not Take Anastrozole Tablets?do Not Take Anastrozole Tablets If You:
  12. Anastrozole Tablets May Not Be Right For You. Before Taking Anastrozole Tablets, Tell Your Doctor About All Your Medical Conditions, Including If You:
  13. Anastrozole Tablets Can Cause Serious Side Effects Including:
  14. Pain On The Right Side Of Your Abdomencommon Side Effects In Women Taking Anastrozole Tablets Include:
  15. How Should I Store Anastrozole Tablets?
  16. What Are The Ingredients In Anastrozole Tablets?

Anastrozole Tablets Are 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

Anastrozole tablets does not work in women with breast cancer who have not gone through menopause (premenopausal women).

Do Not Take Anastrozole Tablet If You: 

  • have had severe allergic reaction to anastrozole or any of the ingredients in anastrozole tablets.

Before You Take Anastrozole Tablets, Tell Your Healthcare Provider If You: 

  • are still having menstrual periods (are not past menopause). Talk to your healthcare provider 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. Taking anastrozole tablets during pregnancy or within 3 weeks of becoming pregnant may harm your unborn baby.
    • Females who are able to become pregnant should have a pregnancy test before starting treatment with anastrozole tablets .
    • Females who are able to become pregnant should use effective birth control (contraceptive) during treatment with anastrozole tablets and for 3 weeks after your last dose of anastrozole tablets. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if anastrozole tablets passes into breast milk. Do not breastfeed during treatment with anastrozole tablets and for 2 weeks after your last dose of anastrozole tablets.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

  • tamoxifen.You should not takeanastrozole tabletsif you take tamoxifen. Taking anastrozole tablets with tamoxifen may lower the amount of anastrozole tablets in your blood and may cause anastrozole tablets not to work as well.
  • Medicines that contain estrogen.Anastrozole tablets 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 healthcare provider and pharmacist when you get a new medicine.

How Should I Take Anastrozole Tablets? 

  • Take anastrozole tablets exactly as your healthcare provider tells you to take it.
  • Continue taking anastrozole tablets until your healthcare provider tells you to stop.
  • Anastrozole tablets 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 dose, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.

If you take too much anastrozole tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Anastrozole Tablets May Cause Serious Side Effects Including: 

    • Store anastrozole tablets at room temperature between 68 F to 77 F (20 C to 25 C).

    Keep anastrozole tablets and all medicines out of the reach of children.

    General information about the safe and effective use of anastrozole tablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take anastrozole tablets for a condition for which it was not prescribed. Do not give anastrozole tablets 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 healthcare provider. You can ask your pharmacist or healthcare provider for information about anastrozole tablets that is written for health professionals. For more information, call 1-800-367-3395 or go to www.bpirx.com.

Active Ingredient: 

anastrozole

Inactive Ingredients: 

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.

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

Manufactured by:
Natco Pharma Limited,
Kothur-509 228, India

Distributed by:
Breckenridge Pharmaceutical, Inc.,
Berlin, CT 06037

346186

May/2019

Manufactured For: 

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Iss. 05/19

AV 10/19 (P)

AvPAK

Patient Information 

See FDA approved patient labeling (Patient Information).

17.1 Pregnancy

Patients should be advised that anastrozole may cause fetal harm. They should also be advised that anastrozole is not for use in premenopausal women; therefore, if they become pregnant, they should stop taking anastrozole tablets and immediately contact their doctor.

17.2 Allergic (Hypersensitivity) Reactions

Patients should be informed of the possibility of serious allergic reactions with swelling of the face, lips, tongue and/or throat (angioedema) which may cause difficulty in swallowing and/or breathing and to seek medical attention immediately.

17.3 Ischemic Cardiovascular Events

Patients with pre-existing ischemic heart disease should be informed that an increased incidence of cardiovascular events has been observed with anastrozole use compared to tamoxifen use. If patients have new or worsening chest pain or shortness of breath they should seek medical attention immediately.

17.4 Bone Effects

Patients should be informed that anastrozole lowers the level of estrogen. This may lead to a loss of the mineral content of bones, which might decrease bone strength. A possible consequence of decreased mineral content of bones is an increase in the risk of fractures.

17.5 Cholesterol

Patients should be informed that an increased level of cholesterol might be seen while receiving anastrozole.

17.6 Tickling, Tingling or Numbness

Patients should be informed that if they experience tickling, tingling, or numbness they should notify their health care provider.

17.7 Tamoxifen

Patients should be advised not to take anastrozole with tamoxifen.

17.8 Missed Doses

Inform patients that if they miss a dose, take it as soon as they remember. If it is almost time for their next dose, skip the missed dose and take the next regularly scheduled dose. Patients should not take two doses at the same time.

Anastrozole Tablets Are Prescription Medicine Used In Women Who Have Finished Menopause ( The Change Of Life ) For: 

  • treatment of early breast cancer


o after surgery, with or without radiation
o in women whose breast cancer is hormone receptor-positive

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  • first treatment of locally advanced or metastatic breast cancer, 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.

Anastrozole tablets do not work in women with breast cancer who have not finished menopause (premenopausal women).

Who Should Not Take Anastrozole Tablets?do Not Take Anastrozole Tablets If You: 

  • are pregnant, think you may be pregnant, or plan to get pregnant. Anastrozole tablets may harm your unborn child. If you become pregnant while taking anastrozole tablets, tell your doctor right away.
  • have not finished menopause (are premenopausal)
  • are allergic to any of the ingredients in anastrozole tablets.

Anastrozole Tablets May Not Be Right For You. Before Taking Anastrozole Tablets, Tell Your Doctor About All Your Medical Conditions, Including If You: 

  • have not finished menopause. Talk to your doctor if you are not sure.

    • Take anastrozole tablets exactly as prescribed by your doctor. Keep taking anastrozole tablets for as long as your doctor prescribes it for you.
    • Take one anastrozole tablet each day.
    • Anastrozole tablets 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 dose, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.
    • If you have taken more anastrozole tablets than your doctor has prescribed, contact your doctor right away. Do not take any additional anastrozole tablets until instructed to do so by your doctor.

    Talk with your doctor about any health changes you have while taking anastrozole tablets.

Anastrozole Tablets Can Cause Serious Side Effects Including: 

  • increased blood cholesterol (fat in the blood).Your doctor may check your cholesterol while you take anastrozole tablets therapy.
  • skin reactions.Stop taking anastrozole tablets 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 have:

swelling of the face, lips, tongue, or throat.

trouble swallowing

trouble breathing

  • liver problems.Anastrozole tablets can cause inflammation of the liver and changes in blood tests of the liver function. Your doctor may monitor you for this. Stop taking anastrozole tablets 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 the skin or whites of the eyes

Pain On The Right Side Of Your Abdomencommon Side Effects In Women Taking Anastrozole Tablets Include: 

hot flashes

weakness

joint pain

carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)

pain

sore throat

mood changes

high blood pressure

depression

nausea and vomiting

thinning of the hair (hair loss)

rash

back pain

sleep problems

bone pain

headache

swelling

increased cough

shortness of breath

lymphedema (build up of lymph fluid in the tissues of your affected arm)
trigger finger (a condition in which one of your fingers or your thumb catches in a bent position)

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 Anastrozole Tablets? 

  • Store anastrozole tablets at 68 F to 77 F (20 C to 25 C).
  • Keep anastrozole tablets and all medicines out of the reach of children.

General information about anastrozole tablets.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take anastrozole tablets for a condition for which it was not prescribed. Do not give anastrozole tablets to other people, even if they have the same symptoms you have. It may harm them.
This patient information leaflet summarizes the most important information about anastrozole tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about anastrozole tablets that is written for health professionals.

What Are The Ingredients In Anastrozole Tablets? 

Active ingredient: anastrozole Inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.
Manufactured by:
Natco Pharma Limited
Kothur - 509 228. A.P. India.
Distributed by:
Breckenridge Pharmaceutical, Inc.,
Boca Raton, FL33487



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