Cardura XL 4mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DOXAZOSIN EXTENDED-RELEASE TABLET - ORAL

(dox-AZE-oh-sin)

USES: This medication is used to treat the symptoms of a condition of the prostate gland called BPH (benign prostatic hyperplasia, also known as enlarged prostate). It is an alpha blocker that works by relaxing the muscles in the bladder neck and prostate. Relaxing these muscles leads to relief of symptoms of BPH such as the feeling of needing to urinate frequently or urgently, weak stream, difficulty in beginning the flow of urine, and the need to urinate during the middle of the night. This medication should not be used to treat high blood pressure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Doxazosin may also be used to help your body "pass," or get rid of, kidney stones through urination. It has also been used to help treat bladder problems in women.

HOW TO USE: Take this medication by mouth, usually once daily with breakfast or as directed by your doctor. Take the first dose at bedtime with food to minimize the chances of dizziness or fainting. Also, any time that your dose is changed, take your first new dose at bedtime. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Use this medication regularly in order to get the most benefit from it. Remember to take it with breakfast each day. Dosage is based on your medical condition and response to therapy. If you are switching from another form of doxazosin to this extended-release form, be sure to follow your doctor's instructions closely to avoid side effects. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, headache, drowsiness, stomach upset/pain, or decreased sexual ability/interest may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. An empty tablet shell may appear in your stool. This is harmless since your body has already absorbed the medication. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, shortness of breath, weakness. Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, dark urine, easy bleeding/bruising, fever, persistent sore throat. Seek immediate medical attention if any of these rare but very serious side effects occur: vision changes, chest pain, jaw/left arm pain, weakness on one side of the body, slurred speech, confusion. In the unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking doxazosin, tell your doctor or pharmacist if you are allergic to it; or to other alpha blockers such as prazosin and terazosin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: prostate cancer, stomach/intestine problems (e.g., short bowel syndrome, chronic constipation, narrowing gut, slow gut movement), heart disease (e.g., congestive heart failure, angina, heart attack in last 6 months), liver disease. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking this drug or if your doctor changes your dose. Also, when you first start taking this drug, avoid situations where you may be injured if you faint. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. The elderly may be at a greater risk for dizziness and low blood pressure while using this drug. Before having surgery (including cataract eye surgery), tell your doctor or dentist that you are taking this medication. During pregnancy, doxazosin should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine, benztropine), drugs to treat erectile dysfunction-ED or pulmonary hypertension (e.g., sildenafil, tadalafil). If you are also taking sildenafil and your dose is more than 25 milligrams, you can reduce your risk of fainting by taking your dose of sildenafil and doxazosin more than 4 hours apart. Consult your doctor or pharmacist if you have any questions. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness, fainting.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., prostate exams, prostate-specific antigen or PSA) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.