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ALFUZOSIN HYDROCHLORIDE tablet, film coated, extended release


  1. Patient Information
  2. Read The Patient Information That Comes With Alfuzosin Hydrochloride Extended-release Tablets Before You Start Using Them And Each Time You Get A Refill. There May Be New Information. This Leaflet Does Not Take The Place Of Talking With Your Doctor About Your Condition Or Your Treatment. You And Your Doctor Should Talk About All Your Medicines, Including Alfuzosin Hydrochloride Extended-release Tablets, Now And At Your Regular Checkups.what Is The Most Important Information I Should Know About Alfuzosin Hydrochloride Extended-release Tablets?
  3. What Are Alfuzosin Hydrochloride Extended-release Tablets?
  4. Do Not Take Alfuzosin Hydrochloride Extended-release Tablets If You:
  5. Especially Tell Your Doctor If You Take:
  6. Ask Your Doctor Or Pharmacist If You Are Not Sure If Your Medicine Is One Of Those Listed Above.what You Need To Know While Taking Alfuzosin Hydrochloride Extended-release Tablets?
  7. How Do I Take Alfuzosin Hydrochloride Extended-release Tablets?
  8. Alfuzosin Hydrochloride Extended-release Tablets Can Cause Serious Side Effects, Including:
  9. Active Ingredient:
  10. Inactive Ingredients:

Patient Information 


SeeFDA-approved patient labeling.

17.1 Hypotension/Syncope


Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning alfuzosin hydrochloride extended-release tablets, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates[seeWarnings and Precautions (5.1)].

17.2 Intraoperative Floppy Iris Syndrome


Patients should be instructed to tell their ophthalmologist about their use of alfuzosin hydrochloride extended-release tablets before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking alfuzosin hydrochloride extended-release tablets[seeWarnings and Precautions (5.6)].

17.3 Priapism


Patients should be advised about the possibility of priapism resulting from treatment with alfuzosin hydrochloride extended-release tablets and medications in the same class. Although this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence)[seeWarnings and Precautions (5.7)].

17.4 Instructions of Use


Alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day.

Patients should be advised not to crush or chew alfuzosin hydrochloride extended-release tablets.

The full text of the patient information is reprinted at the end of this document.




Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Revised: 06/2018

Read The Patient Information That Comes With Alfuzosin Hydrochloride Extended-release Tablets Before You Start Using Them And Each Time You Get A Refill. There May Be New Information. This Leaflet Does Not Take The Place Of Talking With Your Doctor About Your Condition Or Your Treatment. You And Your Doctor Should Talk About All Your Medicines, Including Alfuzosin Hydrochloride Extended-release Tablets, Now And At Your Regular Checkups.what Is The Most Important Information I Should Know About Alfuzosin Hydrochloride Extended-release Tablets? 


Alfuzosin hydrochloride extended-release tablets can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment.
This may cause you to faint, or to feel dizzy or lightheaded.

  • Your risk of having this problem may be increased if you take alfuzosin hydrochloride extended-release tablets with certain other medicine that lowers blood pressure:
    • medicines for high blood pressure
    • a nitrate medicine for angina

Ask your doctor if you are not sure if you are taking one of these medicines.

  • Do not drive, operate machinery, or do any dangerous activities until you know how alfuzosin hydrochloride extended-release tablets affect you.This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.
  • If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.

for more information about side effects.

What Are Alfuzosin Hydrochloride Extended-release Tablets? 


Alfuzosin hydrochloride extended-release tablets are a prescription medicine that is called an alpha-blocker . Alfuzosin hydrochloride extended-release tablets are used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). Alfuzosin hydrochloride extended-release tablets may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.

Before prescribing alfuzosin hydrochloride extended-release tablets, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.

Alfuzosin hydrochloride extended-release tablets are not for use in women or children.

Some medicines called alpha-blockers are used to treat high blood pressure. Alfuzosin hydrochloride extended-release tablets are not for the treatment of high blood pressure.

Do Not Take Alfuzosin Hydrochloride Extended-release Tablets If You: 

  • have certain liver problems
  • take antifungal medicines like ketoconazole or itraconazole (Sporanox)
  • take anti-HIV medicines like ritonavir (Norvir, Kaletra)
  • are allergic to alfuzosin hydrochloride or any of the ingredients in alfuzosin hydrochloride extended-release tablets.

Especially Tell Your Doctor If You Take: 

  • another alpha blocker medicine
  • a medicine to treat high blood pressure
  • a medicine to treat angina
  • a medicine to treat erectile dysfunction (ED)
  • the antifungal medicines like ketoconazole or itraconazole (Sporanox)
  • the anti-HIV medicine like ritonavir (Norvir, Kaletra)

Ask Your Doctor Or Pharmacist If You Are Not Sure If Your Medicine Is One Of Those Listed Above.what You Need To Know While Taking Alfuzosin Hydrochloride Extended-release Tablets? 

  • If you have an eye surgery for cataract (clouding of the eye) planned, tell your ophthalmologist that you are using alfuzosin hydrochloride extended-release tablets or have previously been treated with an alpha-blocker.

How Do I Take Alfuzosin Hydrochloride Extended-release Tablets? 

  • Take alfuzosin hydrochloride extended-release tablets exactly as your doctor prescribes them.
  • Take alfuzosin hydrochloride extended-release tablet after the same meal each day. Do not take it on an empty stomach.
  • Swallow the alfuzosin hydrochloride extended-release tablet whole. Do not crush, split, or chew alfuzosin hydrochloride extended-release tablets.
  • If you take too much alfuzosin hydrochloride extended-release tablets call your local poison control center or emergency room right away.

Alfuzosin Hydrochloride Extended-release Tablets Can Cause Serious Side Effects, Including: 

    • Store alfuzosin hydrochloride extended-release tablets between 15 to 30 C (59 to 86 F).
    • Protect from light and moisture.

    Keep alfuzosin hydrochloride extended-release tabletsand all medicines out of the reach of children.

    General information about alfuzosin hydrochloride extended-release tablets
    :

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use alfuzosin hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give alfuzosin hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. They may harm them.

    This leaflet summarizes the most important information about alfuzosin hydrochloride extended-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alfuzosin hydrochloride extended-release tablets that is written for health professionals.

Active Ingredient: 

alfuzosin hydrochloride

Inactive Ingredients: 

carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide.

The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited.


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Revised: 06/2018



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