Propranolol ER 60mg Capsules

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.

PROPRANOLOL S.R. - ORAL

(pro-PRAN-oh-lol)

COMMON BRAND NAME(S): Betachron, Inderal LA

WARNING: Do not stop using this drug without first consulting your doctor. Your condition may become worse when the drug is suddenly stopped, especially if you have chest pain (angina) or heart disease (e.g., coronary artery disease, ischemic heart disease, high blood pressure). If your doctor decides you should no longer use this drug, you must gradually decrease your dose according to your doctor's instructions. When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Seek immediate medical attention if you develop: worsening chest pain, tightness/pressure in the chest, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

USES: This medication is a beta blocker used to treat high blood pressure, irregular heartbeats, shaking (tremors), and other conditions as determined by your doctor. It is used after a heart attack to improve survival. It is also used to prevent migraine headaches and chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Preventing chest pain can help improve your ability to exercise. This drug works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This effect reduces heart rate, blood pressure, and strain on the heart.

HOW TO USE: See also Warning section. Take this medication by mouth usually once daily; or as directed by your doctor. Swallow the capsules whole; do not crush or chew the capsules. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. This medication is used to help prevent chest pain or migraines. It should not be used to treat chest pain or migraines when they occur. Use other medications (e.g., nitroglycerin tablets placed under the tongue for chest pain, sumatriptan for migraines) to relieve sudden attacks as directed by your doctor. Consult your doctor or pharmacist for details. It may take 1 to 2 weeks before you get the full benefit of this drug. If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take propranolol at least 1 hour before or at least 4 hours after these medications. Tell your doctor if your condition worsens (e.g., your routine blood pressure readings increase, your chest pain or migraines occur more often).

SIDE EFFECTS: See also Warning and Precautions sections. Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Nausea/vomiting, stomach pain, vision changes, trouble sleeping, and unusual dreams may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use. 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: shortness of breath, blue fingers/toes, swelling ankles/feet, mental/mood changes (e.g., depression), numbness/tingling of arms/legs, very slow heartbeat, fainting, decreased sexual ability, unexplained/sudden weight gain, increased thirst/urination. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), aching/swollen joints. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 propranolol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to other beta blockers (e.g., metoprolol); 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: certain types of heart rhythm problems (sinus bradycardia, second- or third-degree atrioventricular block), severe heart failure, asthma. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other breathing problems (e.g., bronchitis, emphysema), heart failure (treated, stable type), other heart problems (e.g., Wolff-Parkinson-White syndrome), overactive thyroid (hyperthyroidism), kidney disease, liver disease, blood circulation problems (e.g., Raynaud's disease), a certain type of tumor (pheochromocytoma), mental/mood disorders (e.g., depression), certain muscle/nerve disease (myasthenia gravis), severe allergic reactions. Before having surgery, tell your doctor or dentist that you are taking this medication. If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product also may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst, hunger, and urination. Your anti-diabetic medication or diet may need to be adjusted. This drug may make you dizzy. 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 reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. During pregnancy, this medication should be used only when clearly needed. Infants exposed to this medication during pregnancy may have low birth weight, low blood sugar, or slow breathing/heartbeat. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medication because very serious interactions may occur: thioridazine. If you are currently using this medication, tell your doctor or pharmacist before starting propranolol. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alpha blockers (e.g., prazosin), aluminum hydroxide, anticholinergics (e.g., atropine, scopolamine), calcium channel blockers (e.g., diltiazem, verapamil), chlorpromazine, diazepam, other drugs to treat high blood pressure (e.g., clonidine, hydralazine, methyldopa, reserpine), epinephrine, fingolimod, haloperidol, other heart medications (e.g., amiodarone, digoxin, disopyramide, propafenone, quinidine), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), mefloquine, rizatriptan, theophylline, thyroid hormones (e.g., levothyroxine), tricyclic antidepressants (e.g., amitriptyline), warfarin, drugs affecting liver enzymes that remove propranolol from your body (such as cimetidine, St. John's wort, certain SSRI antidepressants including fluoxetine/paroxetine/fluvoxamine, HIV protease inhibitors including ritonavir, rifamycins including rifabutin, certain anti-seizure medicines including carbamazepine). 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 heart rate or blood pressure. Ask your pharmacist for more details. This medication may interfere with certain laboratory tests (including glaucoma screening test, cardiovascular stress testing using arbutamine), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. 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, severe dizziness, slow or shallow breathing, weakness, or fainting.

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. Have your blood pressure and pulse checked regularly while taking this medication. It may be best to learn how to monitor your own blood pressure and pulse. Discuss this with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember, but not if it is within 8 hours of the next dose. If it is within 8 hours 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 between 68-77 degrees F (20-25 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.