Polfenon

Leaflet attached to the packaging: patient information

Polfenon, 150 mg, film-coated tablets

Polfenon, 300 mg, film-coated tablets

Propafenone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 pack 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 medicines.

Indications for use

Symptomatic supraventricular tachycardias:

• nodal tachycardia;
• supraventricular tachycardia in patients with Wolff-Parkinson-White syndrome (WPW);
• paroxysmal atrial fibrillation.

Life-threatening, severe, symptomatic ventricular tachycardia (tachycardia is an irregular heart action accompanied by an accelerated heart rate).

2. Important information before taking Polfenon

When not to take Polfenon:

• if the patient is allergic to propafenone hydrochloride, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• Brugada syndrome,
• clinically significant structural heart disease, such as:
• myocardial infarction within the last 3 months,
• uncompensated heart failure with left ventricular ejection fraction below 35%,
• cardiogenic shock, except for shock caused by arrhythmia,
• symptomatic severe bradycardia (bradycardia),
• sinus node dysfunction, atrioventricular conduction disturbances, second- or third-degree atrioventricular block, or bundle branch block in patients without a pacemaker,
• severe hypotension.
• if the patient has symptoms of water and electrolyte balance 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 the patient is taking ritonavir (a medicine used to treat HIV infections) at the same time.

Warnings and precautions

Before starting treatment with Polfenon, the patient should discuss it with their doctor or pharmacist.
Before starting treatment with Polfenon and during treatment, the doctor will order ECG tests, blood pressure measurements, and will assess the patient's clinical condition to determine whether the response to the medicine justifies its use and to rule out Brugada syndrome (a genetically determined heart disease).
Particular caution should be exercised:

• 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 block.
Before a planned procedure, the patient should inform the surgeon or dentist about taking Polfenon.

Polfenon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they 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 an increased risk of side effects from the central nervous system after administering 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 patient's circulatory system and, if necessary, adjust the dose of Polfenon.
The following medicines, when taken with Polfenon, may reduce its effectiveness:

• phenobarbital,
• rifampicin.

In the case of concurrent 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, the patient should not drink grapefruit juice, as it may increase the concentration of the medicine in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using 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 reaction speed and impair the ability to drive and operate machines. If such symptoms occur, the patient should not drive or operate machines.

Polfenon contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 according to the doctor's instructions. In case of doubts, the patient should consult their 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 of the medicine 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 close cardiac monitoring. In patients with lower body weight, lower daily doses should be used.
If there is a significant widening of the QRS complex or a second- or third-degree atrioventricular block, the doctor will consider reducing the dose.
The individual maintenance dose should be determined under cardiac 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 small doses, increasing the dose with special caution, gradually and in small amounts. The same applies to maintenance treatment. If necessary, dose increases can be made no earlier than after 5 to 8 days 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 adjustment of propafenone hydrochloride requires ECG monitoring and serum concentration measurements.

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, burning, numbness) 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, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Polfenon

If a dose of the medicine is missed, it should be taken as soon as possible. If it is already time for the next dose, the missed dose should not be taken. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Polfenon

Treatment should not be discontinued or the dose changed without consulting the doctor.
If the patient has any further doubts about taking this medicine, they should consult their 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) sinus, bradycardia, tachycardia (fast heart rate), atrial flutter.
• Shortness of breath.
• 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 circumference, 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 composition, 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, related to a change in position from lying to standing).
• Vomiting reflex, gastrointestinal disorders.
• Liver cell damage, cholestasis, hepatitis, jaundice.
• Systemic lupus erythematosus-like syndrome (fever, increased blood pressure, skin changes, and joint inflammation).
• Decreased sperm count (reversible after discontinuation of propafenone).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
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 means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 silicon dioxide, magnesium stearate. The ingredients of the tablet coating are: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol, triacetin.

What Polfenon looks like and what the pack contains

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

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: