Polfenon

Package leaflet: information for the patient

Polfenon, 150 mg, film-coated tablets
Polfenon, 300 mg, film-coated tablets
Propafenoni hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Polfenon is and what it is 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 Polfenon is and what it is used for

The active substance in Polfenon is propafenone, which belongs to a group of medicines known as antiarrhythmics.
Indications
Symptomatic supraventricular tachyarrhythmias:

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

Life-threatening, severe, symptomatic ventricular tachyarrhythmia (tachyarrhythmia is an irregular heartbeat associated with a rapid heart rate).

2. Important information before using Polfenon

When not to use 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 been diagnosed with:
• Brugada syndrome,
• clinically significant structural heart disease, such as:
• myocardial infarction within the last 3 months,
• uncontrolled congestive heart failure with left ventricular ejection fraction below 35%,
• cardiogenic shock, except shock caused by arrhythmia,
• symptomatic severe bradycardia,
• sinus node dysfunction, atrial conduction disorders, second- or higher-degree atrioventricular block, bundle branch block, or distal block in patients without a pacemaker,
• severe hypotension.
• if the patient has symptoms of fluid and electrolyte imbalance (e.g. disturbances in potassium metabolism);
• in case of severe obstructive lung disease;
• in patients with myasthenia gravis (a disease characterized by muscle weakness);
• if the patient is concurrently using ritonavir (a medicine used in the treatment of HIV infections).

Warnings and precautions
Before starting treatment with Polfenon, discuss this with your doctor or pharmacist.
Before starting treatment with Polfenon and during treatment, your doctor will order ECG, blood pressure measurements, and assess your clinical condition to confirm the appropriateness of continued treatment and to exclude Brugada syndrome (a genetically determined heart disease).
Exercise particular caution:

• in patients with an implanted cardiac pacemaker – your doctor will check pacemaker function and, if necessary, reprogram it, as the medicine may affect 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 hepatic or renal impairment.

In some patients, the medicine may cause conversion of paroxysmal atrial fibrillation into atrial flutter with 2:1 or 1:1 conduction block.
Before any planned procedure, inform the surgeon or dentist that you are taking Polfenon.
Polfenon and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Polfenon together with the following medicines may increase the risk of adverse effects:

• local anaesthetics (e.g. during pacemaker implantation, surgical or dental procedures),
• other medicines that reduce heart rate and/or myocardial contractility (β-blockers, tricyclic antidepressants). Increased risk of central nervous system adverse effects has been reported when lidocaine is administered to patients taking propafenone.

Polfenon may enhance the effects of the following medicines:

• medicines metabolized by the CYP2D6 isoenzyme, such as
• venlafaxine (used in the treatment of depression),
• desipramine (an antidepressant),
• β-blockers such as propranolol, metoprolol (used in the treatment of high blood pressure),
• cyclosporine (e.g. used in transplant patients),
• theophylline (used in the treatment of asthma),
• digoxin (a cardiac glycoside),
• oral anticoagulants such as phenprocoumon, warfarin.

The following medicines may enhance the effect of Polfenon:

• medicines inhibiting the activity of CYP2D6, CYP1A2 and CYP3A4 isoenzymes:
• ketoconazole (an antifungal medicine),
• cimetidine (used in the treatment of peptic ulcer disease),
• quinidine (an antiarrhythmic medicine),
• erythromycin (a bacteriostatic antibiotic),
• selective serotonin reuptake inhibitors (SSRIs) such as paroxetine, fluoxetine.

If these medicines are used concomitantly with Polfenon, your doctor will monitor cardiovascular function and, if necessary, adjust the dose of Polfenon.
The following medicines, when used with Polfenon, may reduce its effectiveness:

• phenobarbital,
• rifampicin.

When amiodarone is co-administered with Polfenon, dose adjustments of both medicines may be necessary, depending on the patient's response to treatment.
Polfenon with food and drink
See also section 3. During treatment with Polfenon, grapefruit juice should not be consumed, as it may increase the blood concentration of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she must consult her doctor or pharmacist before taking this medicine.
Driving and operating machinery
Some adverse effects such as blurred vision, dizziness, fatigue, and orthostatic hypotension (a sudden drop in blood pressure upon changing from lying to standing position) may affect reaction speed and impair the ability to drive or operate machinery. If such symptoms occur, driving and operating machinery should be avoided.
Polfenon contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Each Polfenon 150 mg tablet contains 1.43 mg of monohydrate lactose.
Each Polfenon 300 mg tablet contains 2.86 mg of monohydrate lactose.

3. How to use Polfenon

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Treatment of ventricular tachyarrhythmias should be conducted under hospital conditions.
The physician will determine the dose individually, depending on individual needs and therapeutic response.
The lowest effective dose should be administered.

Adults
During the dose-titration period and 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. Occasionally, it may be necessary to increase the daily dose of propafenone
hydrochloride, no more frequently than every 3 to 4 days, up to a maximum of 900 mg, provided that
strict cardiac monitoring is maintained. In patients with lower body weight, lower daily doses should be used.
If significant widening of the QRS complex or second- or third-degree atrioventricular block occurs,
the physician may consider reducing the dose.
The individual maintenance dose should be established under cardiac monitoring, including
continuous ECG monitoring and repeated blood pressure measurements (dose-titration phase).

Children and adolescents
The safety and efficacy of this medicine in children and adolescents under 18 years of age have not been established.
Due to its potency, the medicine 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 myocardial damage,
treatment should be initiated with low doses, increasing the dose with particular caution, gradually and in small increments.
The same approach applies during maintenance therapy. Dose increases, if necessary, should not be performed earlier than
5 to 8 days after the previous adjustment.

Renal and/or hepatic impairment
In patients with renal and/or hepatic impairment, administration of standard therapeutic doses may lead to drug accumulation.
In these patients, individual dose adjustment of propafenone hydrochloride requires monitoring of ECG and plasma drug concentration.

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

Use of a higher than recommended dose of Polfenon
In case of overdose, disturbances in heart function and arterial hypotension may occur. Frequently observed symptoms include:
headache, dizziness, blurred vision, sensory disturbances (burning, pricking, tingling) in hands or feet, tremor, nausea, constipation, and dry mouth.
In severe cases of poisoning, seizures, somnolence, coma, and respiratory arrest may additionally occur.
In case of overdose, contact a doctor immediately or go to the nearest hospital.

Missed dose of Polfenon
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose,
the missed dose should not be taken. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The most commonly reported adverse reactions associated with propafenone hydrochloride treatment
are dizziness, conduction disturbances, and palpitations.

Very common (occur in more than 1 in 10 patients)

• Dizziness (excluding dizziness of peripheral origin)
• Impulse conduction disturbances in the heart
• Palpitations

Common (occur in fewer than 1 in 10 patients)

• Anxiety, sleep disturbances
• Headache, taste disturbance
• Blurred vision
• Sinus bradycardia (slow heart rate), bradycardia, tachycardia (fast heart rate), atrial flutter
• Dyspnoea (shortness of breath)
• Abdominal pain, vomiting, nausea, diarrhoea, constipation, dry mouth
• Liver function abnormalities (abnormal liver function tests such as increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased gamma-glutamyltransferase activity, and increased alkaline phosphatase activity in blood)
• Chest pain, weakness, fatigue, fever

Uncommon (occur in fewer than 1 in 10 patients)

• Thrombocytopenia (reduced number of blood platelets)
• Decreased appetite, nightmares
• Fainting, movement coordination disturbances, numbness, tingling
• Dizziness due to ear disorders
• Ventricular tachycardia (excessively fast heartbeat)
• Heart rhythm disorders
• Hypotension (low blood pressure)
• Increased abdominal girth, flatulence
• Urticaria, itching, rash, erythema
• Erectile dysfunction

Frequency not known (frequency cannot be estimated from the available data)

• Agranulocytosis (complete or near-complete absence of granulocytes in the blood), leukopenia (reduced number of leukocytes), granulocytopenia (reduced number of granulocytes)
• Hypersensitivity (may manifest as cholestasis, blood abnormalities, and rash)
• Confusion
• Seizures, extrapyramidal symptoms (gait disturbances, bradykinesia, tremors, and muscle rigidity), motor restlessness
• Ventricular fibrillation, heart failure (may lead to worsening of pre-existing heart failure), decreased heart rate
• Orthostatic hypotension (sudden drop in blood pressure associated with changing position from lying to standing)
• Vomiting reflex, gastrointestinal disturbances
• Liver cell damage, cholestasis, hepatitis, jaundice
• Lupus-like syndrome (fever, elevated blood pressure, skin changes, and joint inflammation)
• Decreased sperm count (reversible after discontinuation of propafenone)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide 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 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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Polfenon contains

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

What Polfenon looks like and contents of the pack
Polfenon 150 mg are white, round, biconvex tablets with a score line. The line on the tablet is not intended for breaking the tablet.
Polfenon 300 mg are white, round, biconvex tablets.
Polfenon 150 mg: packs contain 20, 60, 90 or 120 tablets.
Polfenon 300 mg: packs contain 20 or 60 tablets.

Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01