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|Propafenone Sustained-Release Capsules

Propafenone Sustained-Release Capsules

Propafenone Sustained-Release Capsules is used for:

Treating an irregular heartbeat and helping maintain a normal heart rhythm in patients without structural heart disease.

Propafenone Sustained-Release Capsules is a class 1C antiarrhythmic medicine. It works on different fibers of the heart to stabilize its action and regulate heartbeat.

Do NOT use Propafenone Sustained-Release Capsules if:

• you are allergic to any ingredient in Propafenone Sustained-Release Capsules
• you have congestive heart failure, certain shock conditions, certain types of irregular heartbeat (eg, sick sinus node syndrome, atrioventricular block) and you are not using an artificial pacemaker, slow heartbeat, very low blood pressure, abnormal electrolyte levels, or certain breathing problems (eg, chronic bronchitis or emphysema)
• you are taking another antiarrhythmic (eg, amiodarone, quinidine), droperidol, bepridil, cisapride, an HIV protease inhibitor (eg, ritonavir), a ketolide (eg, telithromycin), macrolide antibiotics (eg, erythromycin), a quinolone antibiotic (eg, ciprofloxacin), a certain type of phenothiazine (eg, thioridazine), a tricyclic antidepressant (eg, imipramine), or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propafenone Sustained-Release Capsules:

Some medical conditions may interact with Propafenone Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems or myasthenia gravis (muscle weakness)
• if you use an artificial pacemaker

Some MEDICINES MAY INTERACT with Propafenone Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because the effectiveness of Propafenone Sustained-Release Capsules may be decreased
• Azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (eg, duloxetine), or venlafaxine because the side effects of Propafenone Sustained-Release Capsules may be increased
• Antiarrhythmics (eg, amiodarone, quinidine), arsenic, bepridil, cisapride, droperidol, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonist antiemetics (eg, dolasetron), tricyclic antidepressants (eg, imipramine), or ziprasidone because the risk of serious side effects, such as abnormal heart rhythms, may be increased
• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), digoxin, haloperidol, or lidocaine because side effects may be increased by Propafenone Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propafenone Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propafenone Sustained-Release Capsules:

Use Propafenone Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Propafenone Sustained-Release Capsules may be taken with or without food.
• Swallow Propafenone Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Take each dose at the same time with respect to meals.
• Take Propafenone Sustained-Release Capsules regularly to receive the most benefit from it. Do not miss any doses.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Propafenone Sustained-Release Capsules in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Propafenone Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propafenone Sustained-Release Capsules.

Important safety information:

• Propafenone Sustained-Release Capsules may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Propafenone Sustained-Release Capsules. Using Propafenone Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Propafenone Sustained-Release Capsules may affect artificial pacemakers. Pacemakers should be monitored and programmed accordingly during therapy.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Propafenone Sustained-Release Capsules.
• LAB TESTS, including electrocardiographic tests, white blood cell counts, and electrolyte levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Propafenone Sustained-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Propafenone Sustained-Release Capsules, discuss with your doctor the benefits and risks of using Propafenone Sustained-Release Capsules during pregnancy. Propafenone Sustained-Release Capsules is excreted in breast milk. Do not breast-feed while taking Propafenone Sustained-Release Capsules.

Possible side effects of Propafenone Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; constipation; dizziness; drowsiness; gas; lightheadedness; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; chills; excessive thirst; fast, slow, or irregular heartbeat; fever; loss of appetite; muscle weakness; prolonged diarrhea; shortness of breath; sore throat; sweating; swelling of the hands or feet; tremor; unexplained weakness; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include convulsions; decreased sexual ability; drowsiness; fainting; fatigue; irregular heartbeat; metallic taste; seizures; severe dizziness or drowsiness; slow heartbeat; weakness.

Store Propafenone Sustained-Release Capsules at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propafenone Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Propafenone Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Propafenone Sustained-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propafenone Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.