Propafenone-150: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PROPAFENONE is used to control certain types of irregular heartbeats (arrhythmias).

What it does:

PROPAFENONE is a heart rate regulating agent. It acts on the metabolism of the heart muscles to block some of the irregular heartbeats. It also acts as a local anaesthetic, blocks the sodium current and slows down the potential of heart muscles reacting fast.

When it should not be used:

PROPAFENONE should not be used if:

1. 2.

   you are allergic to any component of

   PROPAFENONE, including active ingredients and non-active ingredients;

2. 3. you have certain serious heart conditions;
3. 4. you have serious liver failure;
4. 5. you have certain respiratory conditions.

What the medicinal ingredient is:

Propafenone hydrochloride

What the important nonmedicinal ingredients are:

Each film-coated tablet also contains the non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl

methylcellulose, methylcellulose, polyethylene glycol and titanium dioxide.

What dosage forms it comes in:

PROPAFENONE is available as film-coated tablets in the following strengths: 150 mg and 300 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• PROPAFENONE is intended for use only in patients with lifethreatening irregular heartbeats (arrhythmias). Most antiarrhythmic drugs have the potential to cause dangerous arrhythmias; some have been shown to be associated with an increase of sudden death. Your doctor will tell you about the risk and benefits of anti-arrhythmic therapy.

BEFORE you use PROPAFENONE talk to your doctor or pharmacist if:

• you are pregnant or planning to become pregnant, or you are breast-feeding;

• you have any heart disease;
• you have abnormal blood cell counts;
• you have abnormal liver function;
• you have neuromuscular disease (e.g. myasthenia gravis);
• you have kidney disease;
• you have allergies to this drug or any of its ingredients.

• you perform tasks which require special attention

  (for example, driving automobile or operating dangerous machinery) because blurred vision, dizziness, fatigue and low blood pressure are common side effects associated with the administration of PROPAFENONE.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with PROPAFENONE include:

• beta-blockers (e.g. propanolol, metoprolol);
• digoxin, venlafaxine, rifampin, cimetidine, quinidine, ketoconazole, erythromycin, amiodarone, phenobarbital;
• anticoagulants (e.g. warfarin);
• certain local anesthetics (e.g. lidocaine);

• certain antidepressants of the tricyclic group (e.g.

  desipramine), and other antidepressants (e.g. fluoxetine, paroxetine, fluvoxamine);

• some medication that can affect your immune system (e.g. cyclopsorine);

• some HIV-antiviral medication (e.g. ritonavir,

  lopinavir/ritonavir);

• grapefruit juice.

PROPER USE OF THIS MEDICATION

Usual dose:

Dosage must be individualized. The usual adult dose of PROPAFENONE is 150 mg which is to be taken every 8 hours, however your doctor may decide on different individual dosing.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take one tablet, take another as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all.

Never double-up on a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects”. Although not all of these side effects may occur, if they do occur they may need medical attention.

The most common side effects with PROPAFENONE are dizziness, feeling sick (nausea), vomiting, unusual taste and constipation. Other less common side effects may include headaches, blurred vision, abnormal muscular control (ataxia), difficulty in sleeping, tremor, drowsiness, dyspepsia, dry mouth, loss of appetite, abdominal pain/cramping, flatulence, tiredness, skin rash, weakness, chest pain, anxiety, severe sweating and pain in the joints.

Check with your physician or pharmacist if you experience any unexpected effects, or are concerned by the above side effects.

This is not a complete list of side effects. For any unexpected effects while taking PROPAFENONE, contact your doctor or pharmacist.

Check with your pharmacist or doctor immediately, if you experience any of the above symptoms of the serious side effects.

HOW TO STORE IT

Keep PROPAFENONE and all other medicines out of reach of children.

PROPAFENONE tablets should be stored at room temperature 15 to 30°C (59 to 86°F).

Do not take your tablets after the expiry date shown on the label.

It is important to keep the PROPAFENONE tablets in the original package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form

  and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to : Canada Vigilance Program

    Health Canada

    Address Locator: 0701D

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcnada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Pro Doc Ltée at 1-800-361-8559, http://www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée, Laval, Québec, H7L 3W9

Last revised: September 4, 2013