For U.S. Residents Only

Side Effects of UROXATRAL

UROXATRAL provides safety you can trust. However, before starting any treatment you should discuss all the benefits and risks with your doctor.

In clinical trials, the most common side effects associated with UROXATRAL were:

Dizziness
Upper respiratory tract infection
Headache
Fatigue

UROXATRAL has also been associated with a sudden drop in blood pressure, especially near the time of treatment initiation. Low blood pressure may lead to fainting, dizziness or lightheadedness. You should not drive, operate machinery or participate in any dangerous activities until you know how UROXATRAL will affect you. This is especially important if you have already been diagnosed 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. Call your doctor if you experience any side effect that bothers you. Please see the important safety information for UROXATRAL, or ask your doctor or pharmacist for more information.

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.