MYL-Propafenone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• MYL-PROPAFENONE is used to control certain

  types of irregular heartbeats (arrhythmias).

What it does:

MYL-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:

MYL-PROPAFENONE should not be used if:

• you are allergic to any component of MYL-

  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 important 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 forms it comes in:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• MYL-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 MYL-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 MYL-PROPAFENONE.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with MYL-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 MYL-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 MYL-

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.

This is not a complete list of side effects. For any unexpected effects while taking MYL-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 MYL-PROPAFENONE and all other medicines out of reach of children.

MYL-PROPAFENONE tablets should be stored at 15^oC

• 30^oC 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 MYL-PROPAFENONE tablets in the original package.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

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

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E

    Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.Program does not provide medical advice.

MORE INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Revised on: August 11, 2016

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca