Carvedilol ER 80mg 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.

CARVEDILOL EXTENDED-RELEASE - ORAL

(KAR-ve-DIL-ol)

COMMON BRAND NAME(S): Coreg CR

WARNING: Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, he or she may direct you to gradually decrease your dose over 1 to 2 weeks. When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Get medical help right away if you develop chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

USES: Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.

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 may also be used for a certain type of irregular heartbeat (atrial fibrillation).

HOW TO USE: See also Warning section. Read the Patient Information Leaflet if available from your pharmacist before you start taking carvedilol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually once daily in the morning. Swallow the capsule whole. Do not crush or chew the capsule. If you cannot swallow the capsule, you may open the capsule and sprinkle the beads over cool, smooth applesauce. Do not chew the mixture because doing so may cause the drug to be released too quickly, increasing side effects. Swallow all of the mixture right away. Do not prepare the mixture ahead of time for later use. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor\'s instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. For the treatment of high blood pressure, it may take 1 to 2 weeks before you get the full benefit of this drug. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase, or you have worsening symptoms of heart failure like increased shortness of breath).

SIDE EFFECTS: See also Warning and Precautions sections. Dizziness, lightheadedness, drowsiness, diarrhea, impotence, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. The risk of dizziness is highest within 1 hour after you take your dose. Starting treatment with a low dose and slowly increasing your dose as directed by your doctor help to reduce the risk of dizziness. 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 right away if you have any serious side effects, including: very slow heartbeat, severe dizziness, fainting, unusual weakness, signs of kidney problems (such as change in the amount of urine), numbness/tingling of the hands/feet, blue fingers/toes, easy bruising/bleeding, mental/mood changes (such as confusion, depression), seizures. Although this medication may be used to treat heart failure, some people may rarely develop new or worsening symptoms of heart failure, especially at the start of carvedilol treatment. Tell your doctor right away if you develop any of these serious side effects: shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. 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 carvedilol, tell your doctor or pharmacist if you are allergic to it; 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: certain types of heartbeat/heart rhythm problems (such as slow/irregular heartbeat, sick sinus syndrome, second- or third-degree atrioventricular block), breathing problems (such as asthma, chronic bronchitis, emphysema), severe heart failure requiring hospitalization, liver disease, kidney disease, blood circulation problems (such as Raynaud\'s disease, peripheral vascular disease), serious allergic reactions including those needing treatment with epinephrine, overactive thyroid disease (hyperthyroidism), a certain type of tumor (pheochromocytoma), other heart problems (such as Prinzmetal\'s variant angina), a certain muscle disease (myasthenia gravis), certain eye problems (cataracts, glaucoma). This drug may make you dizzy or drowsy or cause you to faint. This is most likely to occur within 1 hour after taking your dose, especially when you start carvedilol treatment or any time your doctor increases your dose. During these periods, avoid driving and doing hazardous tasks. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If you have diabetes, this product may mask the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. People who wear contact lenses may have dry eyes while taking this medication. Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially dizziness and lightheadedness. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. It is unknown if carvedilol passes into breast milk. However, it is unlikely to pass into breast milk in large amounts. There is a low risk that it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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. One product that may interact with this drug is: fingolimod. Some products have ingredients that could raise your heart rate or blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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: very slow heartbeat, severe dizziness, fainting, slow/shallow breathing, seizures.

NOTES: Do not share this medication with others. Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details. Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to monitor your own blood pressure and pulse at home, and share the results with your doctor. Laboratory and/or medical tests (such as kidney and liver function tests) should be performed periodically to monitor your progress or check for side effects.

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. Take your next dose at the regular time. 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.

Information last revised October 2018. Copyright(c) 2018 First Databank, Inc.