Wednesday, October 26, 2016

Propafenone Sustained-Release Capsules



Pronunciation: proe-PA-fen-one
Generic Name: Propafenone
Brand Name: Rythmol SR

Propafenone Sustained-Release Capsules has not been shown to improve the rate of survival in patients with an abnormal heart rhythm. For this reason, Propafenone Sustained-Release Capsules should only be used for certain life-threatening abnormal heart rhythms. Talk with your doctor about the risks and benefits of using Propafenone Sustained-Release Capsules.





Propafenone Sustained-Release Capsules are used for:

Helping to maintain a normal heart rhythm in certain patients who have atrial fibrillation.


Propafenone Sustained-Release Capsules are a class 1C antiarrhythmic medicine. It works in 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, shock caused by severe heart problems, slow heartbeat, very low blood pressure, abnormal electrolyte levels, or certain breathing problems that make you short of breath or wheeze

  • you have certain types of irregular heartbeat (eg, sick sinus syndrome, heart block) and you do not have a permanent pacemaker

  • you are taking another antiarrhythmic (eg, amiodarone, quinidine), cisapride, halofantrine, an HIV protease inhibitor (eg, ritonavir), a ketolide (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), nilotinib, pimozide, a quinolone antibiotic (eg, ciprofloxacin), tetrabenazine, toremifene, vandetanib, 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, lung or breathing problems, lupus, or myasthenia gravis (muscle weakness)

  • if you have a certain abnormal blood test (antinuclear antibody [ANA] test)

  • if you use an artificial pacemaker or if you smoke tobacco

  • if you have low blood pressure or a history of an irregular heartbeat (eg, widening of the QRS complex, atrioventricular [AV] block, ventricular tachycardia or fibrillation), a heart attack, or other heart problems (eg, coronary artery disease)

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:


  • Antiarrhythmics (eg, amiodarone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, domperidone, droperidol, halofantrine, haloperidol, iloperidone, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, nilotinib, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, serotonin receptor antagonist antiemetics (eg, dolasetron), tacrolimus, terfenadine, tetrabenazine, tricyclic antidepressants (eg, desipramine, imipramine), tyrosine kinase receptor inhibitors (eg, dasatinib), vandetanib, or ziprasidone because the risk of serious side effects, such as abnormal heart rhythms, may be increased

  • Abiraterone, azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir, saquinavir), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine, sertraline), or serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine) because they may increase the risk of Propafenone Sustained-Release Capsules's side effects

  • Orlistat or rifamycins (eg, rifampin) because they may decrease Propafenone Sustained-Release Capsules's effectiveness

  • Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), digoxin, or lidocaine because the risk of their 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.


  • An extra patient leaflet is available with Propafenone Sustained-Release Capsules. Talk to your pharmacist if you have questions about this information.

  • Take Propafenone Sustained-Release Capsules by mouth 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 on a regular schedule to get the most benefit from it. Do not miss any doses.

  • Do not eat grapefruit or drink grapefruit juice while you use Propafenone Sustained-Release Capsules.

  • If you miss a dose of Propafenone Sustained-Release Capsules, 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. These effects may be worse if you take it with alcohol or certain medicines. Use Propafenone Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Propafenone Sustained-Release Capsules may affect how artificial pacemakers work. Pacemakers should be monitored and programmed accordingly during therapy.

  • If severe or persistent vomiting, sweating, loss of appetite or thirst, or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • Propafenone Sustained-Release Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Tell your doctor or dentist that you take Propafenone Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Propafenone Sustained-Release Capsules may decrease sperm counts in men. This could affect the ability to father a child. Discuss any questions or concerns with your doctor.

  • Propafenone Sustained-Release Capsules may interfere with certain lab tests, including ANA titers. Be sure your doctor and lab personnel know you are taking Propafenone Sustained-Release Capsules.

  • Lab tests, including electrocardiographic tests, white blood cell counts, and electrolyte levels, may be performed while you use Propafenone Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Propafenone Sustained-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Propafenone Sustained-Release Capsules while you are pregnant. Propafenone Sustained-Release Capsules are found 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; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; light-headedness; nausea; tiredness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, or tingling; change in the amount of urine produced or painful urination; chest pain; confusion; fainting; fast or slow heartbeat; fever, chills, or sore throat; hearing problems; mental or mood problems (eg, anxiety, depression); muscle weakness; new or worsened irregular heartbeat; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness of the calf or legs; ringing in the ears; severe or persistent dizziness, tiredness, or weakness; severe stomach or back pain; shortness of breath; slurred speech; sudden, severe headache; sudden weight gain; swelling of the hands or feet; tremor; trouble sleeping; unusual bruising or bleeding; vomiting; vision problems (eg, blurred vision); wheezing.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Propafenone side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular or slow heartbeat; seizures; severe dizziness or drowsiness.


Proper storage of Propafenone Sustained-Release Capsules:

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 are 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.

  • Check with your pharmacist about how to dispose of unused medicine.

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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Propafenone resources


  • Propafenone Side Effects (in more detail)
  • Propafenone Use in Pregnancy & Breastfeeding
  • Drug Images
  • Propafenone Drug Interactions
  • Propafenone Support Group
  • 20 Reviews for Propafenone - Add your own review/rating


Compare Propafenone with other medications


  • Atrial Fibrillation
  • Atrial Flutter
  • Ventricular Tachycardia
  • Wolff-Parkinson-White Syndrome

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