Consumer Information for: PMS-PROPAFENONE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for
  • pms-PROPAFENONE is used to control certain types of irregular heartbeats (arrhythmias).
What it does

pms-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

pms-PROPAFENONE should not be used if:

  • you are allergic to any component of pms-PROPAFENONE, including active ingredients and non-active ingredients;
  • you have certain serious heart conditions or incidence of heart attack within the last 3 months;
  • you have serious liver failure;
  • you have certain respiratory conditions;
  • you have myasthenia gravis;
  • you are younger than 18
What the medicinal ingredient is

propafenone hydrochloride

What the non-medicinal ingredients are

Sodium Croscarmellose, Microcrystalline Cellulose, Povidone, Hydroxypropyl Methylcellulose, Colloidal Anhydrous Silica, Sodium Lauryl Sulphate, Magnesium Stearate, and coating material Opadry containing Hypermellose, Titanium Dioxide, Macrogol/Polyethylene glycol 400 (150 mg strength) and coating material Opadry containing Titanium Dioxide, Polydextrose, Hypromellose, Triacetin and Macrogol/Polyethylene glycol 8000 (300 mg strength).

For a full listing of non-medicinal ingredients see PART I of the Product Monograph.

What dosage form it comes in

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

Warnings and precautions

Serious Warnings and Precautions

  • pms-PROPAFENONE is intended for use only in patients with life-threatening irregular heartbeats (arrhythmias). Most anti-arrhythmic 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 pms-PROPAFENONE talk to your doctor or pharmacist if:

  • you have a family history of sudden cardiac death or suffer from Brugada Syndrome;
  • 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 pms-PROPAFENONE.
Interactions with this medication

Drugs that may interact with pms-PROPAFENONE include:

  • beta-blockers (e.g. propranolol, 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. cyclosporine);
  • 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 pms-PROPAFENONE is 150 mg which is to be taken every 8 hours, however your doctor may decide on different individual dosing.

The film-coated tablets should be swallowed whole (without chewing) with liquid. Recommended to be taken with food.

Overdose

If you or someone you know accidentally takes more than stated dose, contact your doctor or Regional Poison Control Centre immediately or go to the nearest hospital with the tablets. Tell your doctor or hospital how much was taken. Treat even small overdoses seriously.

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 pms-PROPAFENONE are dizziness, feeling sick (nausea), vomiting, unusual taste and constipation. Other less common side effects may include headaches, blurred vision, 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.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and seek immediate emergency medical attention
Very common
Fast heartbeat, irregular heartbeats   ✔  
Common
Chest pain   ✔  
Dizziness, light-headedness, fainting   ✔  
Liver problems (e.g., yellowing skin or eyes, prolonged vomiting and nausea or abdominal pain)   ✔  
Bleeding problem (excessive bruising, easy bleeding)   ✔  
Not common
Abnormal muscular control (ataxia)   ✔  
Unknown
Heart rate reduced   ✔  
Convulsion, movement disorders (extrapyramidal symptoms), restlessness   ✔  

This is not a complete list of side effects. For any unexpected effects while taking pms-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

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

pms-PROPAFENONE tablets should be stored at 15°C - 30°C in a tight, light-resistant container.

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

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

Reporting 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:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmascience Inc., at 1-888-550-6060.

This leaflet was prepared by
Pharmascience Inc.
Montréal, Québec
H4P 2T4

www.pharmascience.com

Last revised: October 5, 2016

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