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UROXATRAL® (alfuzosin hcl)
(Alfuzosin hydrochloride extended-release tablets)

Read the Patient Information that comes with UROXATRAL (alfuzosin hcl) 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 (alfuzosin hcl) , now and at your regular checkups.

What is the most important information I should know about UROXATRAL (alfuzosin hcl) ?

UROXATRAL (alfuzosin hcl) can cause:

• a sudden drop in blood pressure, especially when you start treatment. This may lead to fainting, dizziness, or lightheadedness. Do not drive, operate machinery, or do any dangerous activities until you know how UROXATRAL (alfuzosin hcl) 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, and if your symptoms do not improve call your doctor.

What is UROXATRAL (alfuzosin hcl) ?

UROXATRAL (alfuzosin hcl) is a prescription medicine that is called an “alpha-blocker”. UROXATRAL (alfuzosin hcl) is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). UROXATRAL (alfuzosin hcl) 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 (alfuzosin hcl) , 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 (alfuzosin hcl) is not for use in women or children.

Some medicines called “alpha-blockers” are used to treat high blood pressure. UROXATRAL (alfuzosin hcl) has not been studied for the treatment of high blood pressure.

Who should not take UROXATRAL (alfuzosin hcl) ?

Do not take UROXATRAL (alfuzosin hcl) if you:

• have liver problems
• are taking antifungal drugs like ketoconazole or HIV drugs called protease inhibitors
• are already taking an alpha-blocker for either high blood pressure or prostate problems
• are a woman
• are a child under the age of 18
• are allergic to UROXATRAL (alfuzosin hcl) . The active ingredient is alfuzosin hydrochloride. See the end of this leaflet for a complete list of ingredients in UROXATRAL (alfuzosin hcl) .

Before taking UROXATRAL (alfuzosin hcl) , tell your doctor:

• if you have liver problems
• if you have kidney problems
• if you or any family members have a rare heart condition known as congenital prolongation of the QT interval.
• 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 you respond or react to UROXATRAL (alfuzosin hcl) .
• if you have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.
• if you have a heart problem called angina (pain in your chest, jaw, or arm).

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 (alfuzosin hcl) or have previously been treated with an alpha-blocker.

How do I take UROXATRAL (alfuzosin hcl) ?

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

What are the possible side effects of UROXATRAL (alfuzosin hcl) ?

The most common side effects with UROXATRAL (alfuzosin hcl) 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 (alfuzosin hcl) . For more information ask your doctor or pharmacist.

How do I store UROXATRAL (alfuzosin hcl) ?

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

Keep UROXATRAL (alfuzosin hcl) and all medicines out of the reach of children.

General information about UROXATRAL (alfuzosin hcl) :

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use UROXATRAL (alfuzosin hcl) for a condition for which it was not prescribed. Do not give UROXATRAL (alfuzosin hcl) 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 (alfuzosin hcl) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about UROXATRAL (alfuzosin hcl) that is written for health professionals.

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

What are the ingredients of UROXATRAL (alfuzosin hcl) ?

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).

Last reviewed on RxList: 5/3/2010
This monograph has been modified to include the generic and brand name in many instances.