Uroxatral (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

UROXATRAL is supplied as follows:

Package NDC Number
Bottles of 100 0024-4200-10

UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

Keep UROXATRAL out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-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 UROXATRAL, 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 [see Warnings and Precautions (5.1)].

17.2 Intraoperative Floppy Iris Syndrome

Patients should be instructed to tell their ophthalmologist about their use of UROXATRAL before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking UROXATRAL [see Warnings and Precautions (5.6)].

17.3 Priapism

Patients should be advised about the possibility of priapism resulting from treatment with UROXATRAL 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) [see Warnings and Precautions (5.7)].

17.4 Instructions of Use

UROXATRAL should be taken with food and with the same meal each day.

Patients should be advised not to crush or chew UROXATRAL tablets.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

© 2011 sanofi-aventis U.S. LLC

PATIENT INFORMATION
UROXATRAL® (yoo-ROX-uh-trahl)
(Alfuzosin hydrochloride
extended-release tablets)

Read the Patient Information that comes with UROXATRAL before you start using it 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 UROXATRAL, now and at your regular checkups.

What is the most important information I should know about UROXATRAL?

UROXATRAL 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 UROXATRAL 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 UROXATRAL affects 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.

See the section “What are the possible side effects of UROXATRAL?” for more information about side effects.

What is UROXATRAL?

UROXATRAL is a prescription medicine that is called an “alpha-blocker”. UROXATRAL is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). UROXATRAL 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 UROXATRAL, 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.

UROXATRAL is not for use in women or children.

Some medicines called “alpha-blockers” are used to treat high blood pressure. UROXATRAL is not for the treatment of high blood pressure.

Who should not take UROXATRAL?

Do not take UROXATRAL if you:

  • have certain liver problems
  • take antifungal medicines like ketoconazole (Nizarol) or itraconazole (Sporanox)
  • take anti-HIV medicines like ritonavir (Norvir, Kaletra)
  • are allergic to alfuzosin hydrochloride or any of the ingredients in UROXATRAL. See the end of this leaflet for a complete list of ingredients in UROXATRAL.

Before taking UROXATRAL, tell your doctor if you:

  • have liver problems
  • have kidney problems
  • have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.
  • have a heart problem called angina
  • or any family members have a rare heart condition known as congenital prolongation of the QT interval.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some of your other medicines may affect the way UROXATRAL works and cause serious side effects. See “What is the most important information I should know about UROXATRAL?

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 (Nizoral ) 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 UROXATRAL (alfuzosin HCl) tablets

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

How do I take UROXATRAL?

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

What are the possible side effects of UROXATRAL?

UROXATRAL can cause serious side effects, including:

The most common side effects with UROXATRAL are:

  • dizziness
  • headache
  • tiredness

Call your doctor if you get any side effect that bothers you.

These are not all the side effects of UROXATRAL. 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 do I store UROXATRAL?

  • Store UROXATRAL between 59°F and 86°F (15°C and 30°C).
  • Protect from light and moisture.

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

General information about UROXATRAL:

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

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

You may also visit our website at www.UROXATRAL.com or call 1-800-446-6267.

What are the ingredients of UROXATRAL?

Active Ingredient: alfuzosin hydrochloride

Inactive Ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

© 2012 sanofi-aventis U.S. LLC

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