Alfuzosin Oral tablet, extended-release

What is this medicine?

ALFUZOSIN (al FYOO zoe sin) is used to treat benign prostatic hyperplasia (BPH) in men. This is a condition that causes you to have an enlarged prostate. This medicine is not for use in women.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

• kidney or liver disease

• low blood pressure

• an unusual or allergic reaction to alfuzosin, other medicines, foods, dyes, or preservatives

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine after the same meal every day. This medicine should be taken just after eating food. Do not take on an empty stomach. Swallow whole. Do not cut, crush or chew this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• droperidol

• levomethadyl

• other medicines for prostate problems

• pimozide

• ritonavir

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• certain medicines for chest pain or blood pressure

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• sildenafil

• tadalafil

• vardenafil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure regularly. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.

Drowsiness and dizziness are more likely to occur after the first dose, after an increase in dose, or during hot weather or exercise. These effects can decrease once your body adjusts to this medicine. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• prolonged or painful erection

• swelling of ankles or legs

• unusually weak or tired

• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation or diarrhea

• difficulty sleeping

• headache

• nausea or upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.