Polfenon

Package Leaflet: Information for the Patient

Polfenon, 150 mg, Film-Coated Tablets

Polfenon, 300 mg, Film-Coated Tablets

Propafenone Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Polfenon and What is it Used For
• 2. Important Information Before Taking Polfenon
• 3. How to Take Polfenon
• 4. Possible Side Effects
• 5. How to Store Polfenon
• 6. Contents of the Package and Other Information

1. What is Polfenon and What is it Used For

The active substance of Polfenon is propafenone, which belongs to the group of antiarrhythmic medications.

Indications for Use

Symptomatic supraventricular tachycardias:

• Atrioventricular nodal reentrant tachycardia;
• Supraventricular tachycardia in patients with Wolff-Parkinson-White syndrome (WPW);
• Paroxysmal atrial fibrillation.

Life-threatening, severe, symptomatic ventricular tachycardia (a heart rhythm disorder characterized by a rapid heart rate).

2. Important Information Before Taking Polfenon

When Not to Take Polfenon:

• if you are allergic to propafenone hydrochloride, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if you have:
• Brugada syndrome,
• clinically significant structural heart disease, such as:
• myocardial infarction within the last 3 months,
• uncompensated heart failure with a left ventricular ejection fraction below 35%,
• cardiogenic shock, unless it is caused by arrhythmia,
• symptomatic severe bradycardia (slow heart rate),
• sinus node dysfunction, atrioventricular conduction disturbances, second- or third-degree atrioventricular block, or bundle branch block in patients without a pacemaker,
• severe hypotension.
• if you have symptoms of water and electrolyte imbalance disorders (e.g., potassium metabolism disorders);
• in case of severe obstructive pulmonary disease;
• in patients with myasthenia gravis (a disease characterized by muscle weakness);
• if you are taking ritonavir (a medicine used to treat HIV infections) at the same time.

Warnings and Precautions

Before starting treatment with Polfenon, discuss it with your doctor or pharmacist.
Before starting treatment with Polfenon and during treatment, your doctor will order an ECG, blood pressure measurement, and assess your clinical condition to determine whether the response to the medicine justifies its use and to exclude Brugada syndrome (a genetically determined heart disease).
Particular caution is required:

• in patients with a pacemaker - the doctor will check the pacemaker's function and, if necessary, reprogram it, as the medicine may affect the stimulation threshold and sensitivity of the implanted pacemaker;
• in patients with clinically significant structural heart disease, the medicine is contraindicated;
• in patients with asthma;
• in patients with liver and kidney failure.

In some patients, the medicine may cause paroxysmal atrial fibrillation to transition into atrial flutter with a 2:1 or 1:1 conduction ratio.
Before a planned surgery, inform the surgeon or dentist that you are taking Polfenon.

Polfenon and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Taking Polfenon with the following medicines may increase the risk of side effects:

• local anesthetics (e.g., during pacemaker implantation, surgery, or dental procedures),
• other medicines that slow the heart rate and/or reduce the contractility of the heart muscle (β-adrenergic blockers, tricyclic antidepressants). There have been reports of increased risk of side effects from the central nervous system after administration of lidocaine to patients taking propafenone.

Polfenon may increase the effect of the following medicines:

• medicines metabolized by the CYP2D6 isoenzyme, such as
• venlafaxine (a medicine used to treat depression),
• desipramine (an antidepressant),
• β-adrenergic blockers, such as propranolol, metoprolol (used to treat high blood pressure),
• cyclosporine (used, for example, in the treatment of transplant patients),
• theophylline (used to treat asthma),
• digoxin (a heart medicine),
• oral anticoagulants, such as phenprocoumon, warfarin.

The following medicines may increase the effect of Polfenon:

• medicines that inhibit the activity of CYP2D6, CYP1A2, and CYP3A4 isoenzymes:
• ketoconazole (an antifungal medicine),
• cimetidine (a medicine used to treat stomach and duodenal ulcers),
• quinidine (an antiarrhythmic medicine),
• erythromycin (an antibacterial antibiotic),
• antidepressants from the group of selective serotonin reuptake inhibitors, such as paroxetine, fluoxetine.

If these medicines are taken at the same time as Polfenon, the doctor will monitor the cardiovascular system and, if necessary, adjust the dose of Polfenon.
The following medicines, when taken with Polfenon, reduce its effectiveness:

• phenobarbital,
• rifampicin.

In the case of concomitant administration of amiodarone and Polfenon, it may be necessary to adjust the doses of both medicines, taking into account the patient's response to treatment.

Polfenon with Food and Drink

See also section 3. During treatment with Polfenon, do not drink grapefruit juice, as it may increase the concentration of the medicine in the blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and Operating Machines

Some side effects, such as blurred vision, dizziness, fatigue, and orthostatic hypotension (a sudden drop in blood pressure caused by a change in position from lying to standing), may affect your reaction speed and ability to drive and operate machines. If you experience such symptoms, do not drive or operate machines.

Polfenon Contains Lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.
Each Polfenon 150 mg tablet contains 1.43 mg of lactose monohydrate.
Each Polfenon 300 mg tablet contains 2.86 mg of lactose monohydrate.

3. How to Take Polfenon

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Treatment of ventricular tachycardias should be carried out in a hospital setting.
The doctor will determine the dose individually, depending on the patient's needs and therapeutic response.
The smallest effective dose should be administered.
Adults
In the dose-titration period and during maintenance treatment in patients with a body weight of approximately 70 kg, the recommended daily dose of propafenone hydrochloride is 450 to 600 mg, given in 2 or 3 divided doses. Sometimes it may be necessary to increase the daily dose of propafenone hydrochloride, but not more often than every 3-4 days, up to 900 mg, provided that there is strict cardiological monitoring. In patients with a lower body weight, lower daily doses should be used.
In case of significant QRS complex widening or second- or third-degree atrioventricular block, the doctor will consider reducing the dose.
The individual maintenance dose should be determined under cardiological monitoring, including ECG recording and multiple blood pressure measurements (dose-titration phase).
Children and Adolescents
The safety and efficacy of Polfenon in children and adolescents under 18 years of age have not been established.
Due to the strength of the medicine, it should not be used in children and adolescents.
Elderly Patients
In elderly patients and in patients with significant left ventricular dysfunction (ejection fraction <35%) or heart muscle damage, treatment should be started with low doses, and the dose should be increased with particular caution, gradually and in small increments. The same applies to maintenance treatment. If necessary, dose increases can be made no earlier than 5 to 8 days after the start of treatment.
Renal and/or Hepatic Impairment
In patients with renal and/or hepatic impairment, after administration of standard therapeutic doses, accumulation of the medicine may occur. In these patients, individual dose titration of propafenone hydrochloride requires monitoring of the ECG and serum concentration of the medicine.

Method of Administration

The medicine should be taken after a meal, with a small amount of liquid.

Overdose of Polfenon

In case of overdose, cardiac conduction disorders and hypotension may occur. Often, the following symptoms also occur: headache, dizziness, blurred vision, sensory disturbances (tingling, numbness, prickling) of the hands or feet, tremors, nausea, constipation, and dry mouth. In severe cases of poisoning, additional symptoms may include seizures, drowsiness, coma, and respiratory arrest.
In case of overdose, contact a doctor or go to the nearest hospital immediately.

Missed Dose of Polfenon

If you miss a dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Polfenon

Do not stop treatment or change the dosage without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Polfenon can cause side effects, although not everybody gets them.
The most common side effects associated with propafenone hydrochloride treatment are dizziness, conduction disturbances, and palpitations.
Very Common(occurring in more than 1 in 10 patients)

• Dizziness (excluding dizziness of peripheral origin).
• Conduction disturbances in the heart.
• Palpitations.

Common(occurring in less than 1 in 10 patients)

• Anxiety, sleep disturbances.
• Headache, taste disturbance.
• Blurred vision.
• Bradycardia (slow heart rate) of sinus origin, bradycardia, tachycardia (fast heart rate), atrial flutter.
• Dyspnea.
• Abdominal pain, vomiting, nausea, diarrhea, constipation, dry mouth.
• Abnormal liver function (abnormal liver test results, such as increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased gamma-glutamyltransferase activity, and increased alkaline phosphatase activity in the blood).
• Chest pain, weakness, fatigue, fever.

Uncommon(occurring in less than 1 in 10 patients)

• Thrombocytopenia (reduced platelet count).
• Decreased appetite, nightmares.
• Fainting, coordination disorders, numbness, tingling.
• Dizziness due to ear disorders.
• Ventricular tachycardia (too fast heart rate).
• Arrhythmias.
• Hypotension.
• Increased abdominal girth, bloating with gas discharge.
• Urticaria, itching, rash, flushing.
• Erectile dysfunction.

Frequency Not Known(frequency cannot be estimated from the available data)

• Agranulocytosis (complete or almost complete lack of granulocytes in the blood), leukopenia (reduced white blood cell count), granulocytopenia (reduced granulocyte count).
• Hypersensitivity (may manifest as cholestasis, abnormal blood count, and rash).
• Confusional state.
• Seizures, extrapyramidal symptoms (gait disturbances, slowed movement, tremors, and muscle stiffness), restlessness.
• Ventricular fibrillation, heart failure (may worsen existing heart failure), decreased heart rate.
• Orthostatic hypotension (sudden drop in blood pressure associated with a change in position from lying to standing).
• Vomiting reflex, gastrointestinal disturbance.
• Liver cell damage, cholestasis, hepatitis, jaundice.
• Lupus-like syndrome (fever, increased blood pressure, skin changes, and joint inflammation).
• Decreased sperm count (reversible after discontinuation of propafenone).

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Polfenon

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Polfenon Contains

• The active substance of Polfenon is propafenone hydrochloride. Each tablet contains 150 mg or 300 mg of propafenone hydrochloride.
• The other ingredients are: copovidone, gelatin, glycerol 85%, cornstarch, colloidal silica, magnesium stearate. The ingredients of the tablet coating are: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol, triacetin.

What Polfenon Looks Like and Contents of the Package

Polfenon 150 mg is a white, round, biconvex tablet with a score line. The score line is not intended for breaking the tablet.
Polfenon 300 mg is a white, round, biconvex tablet.
Polfenon 150 mg: the package contains 20, 60, 90, or 120 tablets.
Polfenon 300 mg: the package contains 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of Last Revision of the Package Leaflet: