For U.S. Residents Only

Taking UROXATRAL

Take UROXATRAL exactly as prescribed by your doctor. UROXATRAL is typically prescribed as a once-daily 10-mg tablet. UROXATRAL can safely be administered in elderly patients and patients with ischemic heart disease, diabetes or hypertension.

Some helpful suggestions on taking UROXATRAL:

UROXATRAL should be taken immediately after the same meal each day
Do not take the tablet on an empty stomach. UROXATRAL tablets should be swallowed whole. Do not chew, crush or split the tablet
If you miss a dose of UROXATRAL call your doctor or pharmacist
If you take too much UROXATRAL call your local poison control center or emergency room right away

Before taking UROXATRAL, 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
If you have experienced low blood pressure, especially after taking another medicine
If you have a heart problem called angina

Do NOT take UROXATRAL if you:

Have liver problems
Are taking antifungal drugs like ketoconazole
Are taking HIV drugs called protease inhibitors
Are already taking an alpha-blocker either for high blood pressure or prostate problems
Are a woman
Are a child under the age of 18
Are allergic to alfuzosin, the active ingredient in UROXATRAL or any of the other ingredients in UROXATRAL (see full prescribing information for a complete list of ingredients in UROXATRAL)

Indication
UROXATRAL® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.

Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.

UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.

Before taking UROXATRAL, tell your doctor if you have kidney problems.

Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.

BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.

The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.

Please see UROXATRAL patient information.