Innopran XL 120mg 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 EXTENDED-RELEASE - ORAL

(pro-PRAN-oh-lol)

COMMON BRAND NAME(S): Innopran XL

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. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. 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 results 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. Propranolol has also been used for irregular heartbeats, shaking (tremors), and to control symptoms of anxiety or overactive thyroid (hyperthyroidism). It has been used after a heart attack to improve survival. Propranolol may also be used to help prevent chest pain (angina) or migraine headaches. 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.

HOW TO USE: See also Warning section. Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Swallow the capsules whole. Do not crush or chew the capsules. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. 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. Most people with high blood pressure do not feel sick. 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).

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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, bronchitis, emphysema), heart failure, certain types of heart rhythm problems (sinus bradycardia, Wolff-Parkinson-White syndrome, second- or third-degree atrioventricular block), 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. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: 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), mefloquine, rizatriptan, theophylline, thioridazine, thyroid hormones (e.g., levothyroxine), 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.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. 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 away from light and moisture. Do not store in the bathroom. Keep all medications 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.