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ANASTROZOLE- anastrozole tablets tablet


  1. Anastrozole Tablets Is A Prescription Medicine Used In Women After Menopause ( The Change Of Life ) For:
  2. Do Not Take Anastrozole Tablets 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. How Should I Store Anastrozole Tablets?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Patient Information

Anastrozole Tablets 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

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

Do Not Take Anastrozole Tablets If You: 


have had a 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. You and your healthcare provider should decide if you will take Anastrozole Tablets or breastfeed. You should not do both.


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 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 Anastrozole Tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Anastrozole Tablets May Cause Serious Side Effects Including: 



bone thinning or weakness (osteoporosis). Anastrozole Tablets 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 healthcare provider may order a bone mineral density test before you start and during treatment with Anastrozole Tablets to check you for bone changes.
increased blood cholesterol (fat in the blood). Your healthcare provider may do blood tests to check your cholesterol while you are taking Anastrozole Tablets.
skin reactions. Stop taking Anastrozole Tablets and call your healthcare provider 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
liver problems.Anastrozole Tablets can cause inflammation of your liver and changes in liver function blood tests. Your healthcare provider may check you for this.


Stop taking Anastrozole Tablets and call your healthcare provider right awayif 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 Anastrozole Tablets 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)
Anastrozole tablets may also cause you to have tickling, tingling or numbness of your skin.
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 Anastrozole Tablets. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to Yiling Pharmaceutical, Inc. at 1-877-736-5697 or FDA at 1-800-FDA-1088.

How Should I Store Anastrozole Tablets? 

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 1-877-736-5697.

Active Ingredient: 

anastrozole

Inactive Ingredients: 

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol sodium starch glycolate, and titanium dioxide.

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

Revised: 01/2019

Manufactured by:
Beijing Yiling Bio-engineering Technology Co., Ltd.
No. 23 Keji Road, Industrial Park, Miyun, Beijing, China, 101500

Distributed by:
Yiling Pharmaceutical, Inc.
5348 Vegas Drive, Las Vegas, NV 89108, USA

Patient Information 

See FDA Approved Patient Labeling (Patient Information).

Hypersensitivity Reactions
Inform patients 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 [seeContraindications (4)].
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.
Bone Effects
Inform patients 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 [seeWarnings and Precautions (5.2)].
Cholesterol
Patients should be informed that an increased level of cholesterol might be seen while receiving Anastrozole.
Carpal Tunnel
Patients should be informed that if they experience tickling, tingling, or numbness they should notify their health care provider [seeAdverse Reactions (6.1)].
Tamoxifen
Patients should be advised not to take Anastrozole with Tamoxifen[seeClinical Studies (14.1)].
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.

Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during Anastrozole therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with Anastrozole [seeWarning and Precautions (5.4)and Use in Specific Populations (8.1,8.3)].
Lactation
Advise women not to breastfeed during Anastrozole treatment and for at least 2 weeks after the last dose [seeUse in Specific Population (8.2)].



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