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Acebutolol 400mg Capsules
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Product ID: *ACELOL400
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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.

ACEBUTOLOL - ORAL

(A-se-BUE-toe-lol)

COMMON BRAND NAME(S): Sectral

USES: Acebutolol is used alone or with other medications to treat high blood pressure and irregular heartbeat (arrhythmia). Lowering high blood pressure prevents strokes, heart attacks, and kidney problems. Treating irregular heartbeat helps the heart to work better with less strain. Irregular heart beats can be serious and sometimes lead to heart attacks, which may be fatal. This medication belongs to a class of medications called beta-blockers. It works by blocking the action of certain natural chemicals (such as adrenaline and epinephrine) that affect the heart and blood vessels, resulting in a lowering of heart rate, blood pressure, and strain on the heart.

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. This drug is also used for a certain type of chest pain (angina). It can decrease your need for nitrate drugs and improve your ability to exercise by preventing the heart from working too hard. It can also improve heart failure by decreasing the amount of work your heart needs to do. Your doctor may also use this medication to treat other conditions.

HOW TO USE: Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor. Your dosage is based on your medical condition and your response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. This medication treats, but does not cure, high blood pressure. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Do not stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Also, notify your doctor immediately of any worsening chest pain. It may take 1 to 2 weeks before you get the full benefit of this medication. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, tiredness, constipation, diarrhea, stomach upset/gas, nausea, trouble sleeping or unusual dreams may occur as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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. This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Avoid tobacco use and dress warmly. Tell your doctor immediately if any of these unlikely but serious side effects occur: bluish discoloration of the fingers/toes/nails, severe tiredness, mental/mood changes (e.g., depression, confusion, memory problems), numbness/tingling, decreased sexual ability, trouble breathing, swelling of the feet/ankles, vision changes, unexplained/sudden weight gain. Seek immediate medical attention if any of these unlikely but very serious side effects occur: chest pain, persistent dizziness/fainting, slow/fast/irregular heartbeat, jaw/left arm pain, black stools, rectal bleeding, severe stomach/abdominal pain. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, persistent joint/muscle pain, painful erections. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin. 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 acebutolol, tell your doctor or pharmacist if you are allergic to it; or to other beta-blockers (e.g., propranolol); 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very slow heartbeat (e.g., severe bradycardia, second- or third-degree atrioventricular block), a certain serious heart problem (cardiogenic shock), uncontrolled severe heart failure. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (e.g., Raynaud's disease, peripheral vascular disease), breathing problems (e.g., asthma, chronic obstructive pulmonary disease), decreased blood flow to the heart or brain (e.g., coronary artery disease, stroke, transient ischemic attacks), diabetes, heart problems (e.g., history of heart failure, recent heart attack, valve problems), kidney problems, liver problems, mental/mood disorders (e.g., depression), certain muscle problems (myasthenia gravis), overactive thyroid disease (hyperthyroidism). 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. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Before having surgery, tell your doctor or dentist that you are taking this medication. This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst or urination. If you already have diabetes, be sure to check your blood sugar regularly. This medication may mask the fast/pounding heartbeat, nervousness and shakiness you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar, such as hunger, dizziness and sweating, are unaffected by this drug. If you have chest pain (angina) or have heart disease (e.g., coronary artery disease, ischemic heart disease, high blood pressure), do not stop using this drug without first consulting your doctor. Your condition may become worse when the drug is suddenly stopped. If your doctor decides you should no longer use this drug, you must gradually decrease your dose according to your doctor's instructions. Seek immediate medical attention if you develop: worsening chest pain, tightness or pressure in the chest, chest pain spreading to the jaw/neck/arm, sweating, trouble breathing, fast/irregular heartbeat. Caution is advised when using this drug in the elderly because they may be more sensitive to side effects. This medication should be used only when clearly needed during pregnancy. Newborns whose mothers have taken this drug near the date of delivery may have problems such as low blood pressure, low heart rate and low birth weight, and may require special medical monitoring. Discuss the risks and benefits of taking this medication during pregnancy with your doctor. This drug 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. This drug should not be used with the following medication because very serious interactions may occur: arbutamine, disopyramide. If you are currently using this medication, tell your doctor or pharmacist before starting acebutolol. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs to lower blood pressure (e.g., alpha-blockers such as prazosin, beta-blockers such as nadolol, clonidine, calcium-channel blockers such as diltiazem/verapamil, reserpine), bronchodilators (e.g., albuterol), epinephrine, fenoldopam, fingolimod, nasal decongestants (e.g., phenylephrine, pseudoephedrine), "water pills" (e.g., diuretics such as furosemide). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or heart rate, or cause drowsiness. Ask your pharmacist for more details. 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: unusually slow heartbeat, fainting, loss of consciousness, severe weakness, seizures, slow/shallow breathing.

NOTES: Do not share this medication with others. Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Laboratory and/or medical tests (e.g., blood pressure, pulse) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure and pulse checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure and pulse.

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. 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 August 2012. Copyright(c) 2012 First Databank, Inc.

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