Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rytmonorm 300 (Rytmonorm 300 mg), 300 mg, coated tablets
Propafenoni hydrochloridum
Rytmonorm 300 and Rytmonorm 300 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully 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 doubts, 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 someone else, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Rytmonorm 300 and what is it used for
Important information before taking Rytmonorm 300
How to take Rytmonorm 300
Possible side effects
How to store Rytmonorm 300
Contents of the pack and other information

1. What is Rytmonorm 300 and what is it used for

Propafenone hydrochloride – the active substance in Rytmonorm 300 – has antiarrhythmic action, meaning it restores or maintains normal heart rhythm. The drug's mechanism of action is complex and includes, among others, stabilization of the cell membrane and blockade of sodium channels. Propafenone hydrochloride also exhibits weak β-adrenolytic activity.

Rytmonorm 300 is indicated:

for symptomatic supraventricular tachyarrhythmias requiring treatment, such as nodal tachycardia, supraventricular tachycardia in patients with Wolff-Parkinson-White (WPW) syndrome, or paroxysmal atrial fibrillation;
for severe symptomatic ventricular tachyarrhythmia, if the physician considers it life-threatening.

2. Important information before using Rytmonorm 300

When not to use Rytmonorm 300

If the patient is allergic to the active substance or to 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,
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 (a disease characterized by muscle weakness).
If the patient is taking ritonavir (a medicine used to treat HIV infections).

Warnings and precautions
Before starting treatment with Rytmonorm 300, consult your doctor.
Propafenone, like other antiarrhythmic medicines, may cause proarrhythmic effects, i.e.
it may induce new or worsen previously existing cardiac arrhythmias (see section 4).
Before starting treatment with Rytmonorm 300 and during treatment, your doctor will order
ECG tests and assess your clinical condition to determine whether the response to the medicine
confirms its continued use and to exclude Brugada syndrome (a genetically determined heart disease).
Special caution is required:

in patients with an implanted pacemaker; the doctor will check the pacemaker function and, if necessary, reprogram it, because 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 some patients, the medicine may cause conversion of paroxysmal atrial fibrillation into atrial flutter with associated 2:1 or 1:1 conduction block.
Rytmonorm 300 and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Rytmonorm 300 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 (beta-blockers, tricyclic antidepressants). Increased risk of lidocaine-induced central nervous system adverse effects has been reported when lidocaine was administered concomitantly with propafenone hydrochloride.

Rytmonorm 300 may increase the effects of the following medicines:

medicines metabolized by the CYP2D6 isoenzyme, such as venlafaxine,
beta-blockers, such as propranolol, metoprolol,
antidepressants, such as desipramine,
immunosuppressive medicines, such as cyclosporine,
medicines used to treat asthma, such as theophylline,
cardiac glycosides, such as digoxin,
oral anticoagulants, such as phenprocoumon, acenocoumarol, warfarin.

The following medicines may increase the effect of Rytmonorm 300:

antifungal medicines (e.g. ketoconazole),
medicines used to treat peptic ulcer disease (e.g. cimetidine),
antiarrhythmic medicines (e.g. quinidine),
antibacterial medicines – antibiotics (e.g. erythromycin),
antidepressants from the selective serotonin reuptake inhibitors (SSRIs) group, such as paroxetine, fluoxetine.

If these medicines are used concomitantly with Rytmonorm 300, your doctor will monitor cardiovascular function and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when used concomitantly with Rytmonorm 300, may reduce its effectiveness:

phenobarbital,
rifampicin.

When treating concomitantly with amiodarone and Rytmonorm 300, dosage adjustment of both medicines may be necessary, based on the treatment response.
Children and adolescents
Studies on the influence of one medicine on the effects of another have been conducted
only in adults. It is not known whether the extent of such interactions in children and adolescents is similar
to that in adults.
Rytmonorm 300 and grapefruit juice
Grapefruit juice may increase the blood concentration of propafenone hydrochloride.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Rytmonorm 300 may be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Excretion of propafenone into human milk has not been studied. Limited data suggest that propafenone may pass into breast milk. Caution should be exercised when administering Rytmonorm 300 to breastfeeding women.
Driving and using machines
Some adverse effects, such as blurred vision, dizziness, fatigue, and orthostatic hypotension (sudden drop in blood pressure upon changing position from lying to standing), may affect reaction speed and impair the ability to drive or operate machinery. If such symptoms occur, do not drive or operate any machinery.
Rytmonorm 300 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Rytmonorm 300

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The doctor will determine the dosage individually.
Due to the bitter taste of propafenone and its local anesthetic effect, the coated tablets
must be swallowed whole (without chewing) with a drink.
Adults
During the dose-finding period and in maintenance therapy, the recommended daily dose of propafenone hydrochloride in patients weighing approximately 70 kg is 450 to 600 mg, administered in two or
three divided doses. Occasionally, it may be necessary to increase the daily dose of propafenone hydrochloride up to 900 mg. In patients with lower body weight, the doctor will appropriately reduce the daily dose. The dose may be increased only after 3 to 4 days of treatment.
If significant widening of the QRS complex or second- or third-degree atrioventricular block occurs, the doctor will consider reducing the dose.
The individual maintenance dose should be established under cardiological supervision, including
continuous ECG monitoring and repeated blood pressure measurements (dose-titration phase).
Use in children
Rytmonorm 300, due to its strength, must not be used in children.
Elderly patients
In elderly patients, or in patients with significant left ventricular dysfunction (left ventricular ejection fraction below 35%) or structural heart disease, treatment should be initiated gradually with special caution, using small, incrementally increased doses. The same applies to maintenance therapy. If dose escalation is necessary, it may only be performed after five to eight days of treatment.
Patients with hepatic and/or renal impairment
In patients with hepatic and/or renal dysfunction, accumulation of the drug may occur after administration of normally recommended therapeutic doses. In such patients, the doctor will individually adjust the dosage, monitoring ECG tracings and plasma drug concentrations.
Use of a higher than recommended dose of Rytmonorm 300
In case of overdose, disturbances in heart function, cardiac arrest, hypotension, and in severe cases, cardiogenic shock may occur.
Other possible symptoms include: metabolic acidosis (a condition of disturbed acid-base balance in the body), headache, dizziness, blurred vision, sensory disturbances (burning, pricking, tingling) in hands or feet, tremor, nausea, constipation, dry mouth, and seizures (convulsions).
Fatal outcomes have also been reported.
In severe cases of poisoning, tonic-clonic seizures (seizures with loss of consciousness and muscle contractions throughout the body), paresthesia (tingling sensation), drowsiness, coma, and respiratory arrest may additionally occur.
In case of overdose, immediate medical attention at the nearest hospital is required.
Missed dose of Rytmonorm 300
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly reported adverse reactions associated with propafenone hydrochloride treatment
are dizziness, conduction disorders, and palpitations.
The adverse reactions listed below have been reported in clinical trials and following the marketing of
propafenone hydrochloride.
Very common (in at least 1 out of 10 patients)

Dizziness (excluding peripheral vertigo).
Cardiac conduction disorders.
Palpitations.

Common (in 1 to 10 out of 100 patients)

Anxiety, sleep disorders.
Headache, taste disturbance.
Blurred vision.
Sinus bradycardia (slow heart rate), bradycardia, tachycardia (fast heart rate), atrial flutter.
Dyspnea (shortness of breath).
Abdominal pain, vomiting, nausea, diarrhoea, constipation, dry mouth.
Abnormal liver function (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, asthenia (weakness), fatigue, fever.

Uncommon (in 1 to 10 out of 1,000 patients)

Thrombocytopenia (low number of blood platelets).
Decreased appetite, nightmares.
Fainting, ataxia (impaired coordination), paresthesia (numbness, tingling).
Dizziness.
Ventricular tachycardia.
Cardiac arrhythmia.
Hypotension (low blood pressure).
Increased abdominal girth, flatulence.
Urticaria, itching, rash, erythema.
Erectile dysfunction.

Frequency unknown (frequency cannot be estimated from available data)

Agranulocytosis (complete or almost complete absence of granulocytes in blood), leukopenia (reduced number of white blood cells), granulocytopenia (reduced number of granulocytes).
Hypersensitivity (may manifest as cholestasis, blood abnormalities, and rash).
Confusional state.
Seizures, extrapyramidal symptoms, akathisia (restlessness).
Ventricular fibrillation, heart failure (may lead to worsening of pre-existing heart failure), reduced heart rate.
Orthostatic hypotension (sudden drop in blood pressure related to changing position from lying to standing).
Nausea, gastrointestinal disturbances.
Hepatocellular injury, cholestasis, hepatitis, jaundice.
Lupus-like syndrome.
Acneiform skin eruptions.
Reduced sperm count (reversible after discontinuation of propafenone).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet,
please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rytmonorm 300

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rytmonorm 300 contains

The active substance is propafenone hydrochloride. One coated tablet contains 300 mg of the active substance.
The other ingredients are microcrystalline cellulose, sodium croscarmellose, pregelatinized starch, hypromellose, magnesium stearate, purified water. The film-coating contains: macrogol 400, macrogol 6000, hypromellose, titanium dioxide (E 171).

What Rytmonorm 300 looks like and contents of the pack
Rytmonorm 300 is available as film-coated tablets. The film-coated tablet is white,
biconvex, with the imprint “300” on one side.
Available pack sizes:
20 tablets – 2 blisters of 10 tablets
50 tablets – 5 blisters of 10 tablets
PVC/Aluminium blisters in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Viatris SIA, Mūkusalas 101, LV 1004 Riga, Latvia
Manufacturer:
Mylan Hungary Kft., Mylan utca 1, 2900 Komárom, Hungary
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Latvia, country of export: 00-0739
Parallel Import Number: 367/25