Package leaflet: information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is 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 this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
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. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Propafenone hydrochloride – the active substance in Rytmonorm 300 – has antiarrhythmic properties, meaning it restores or maintains normal heart rhythm. The mechanism of action of this medicine 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, when 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 been diagnosed with:
Brugada syndrome,
Clinically significant structural heart disease, such as:
Myocardial infarction within the last 3 months,
Uncompensated congestive heart failure with left ventricular ejection fraction below 35%,
Cardiogenic shock, excluding 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 currently taking ritonavir (a medicine used in the treatment of HIV infections).

Warnings and precautions
Before starting treatment with Rytmonorm 300, discuss this with your doctor.
Propafenone, like other antiarrhythmic drugs, may cause a proarrhythmic effect,
i.e. it may induce new or worsen pre-existing cardiac arrhythmias (see section 4).
Before starting treatment with Rytmonorm 300 and during treatment, your doctor will order
electrocardiogram (ECG) tests and assess the patient's clinical condition to determine whether the response to the
medication justifies its continued use and to exclude Brugada syndrome (a genetically
determined heart disease).
Particular caution is required:

In patients with an implanted cardiac pacemaker; the doctor will check pacemaker function and, if necessary, reprogram it, because the drug may affect the stimulation threshold and sensitivity of the implanted pacemaker;
In patients with clinically significant structural heart disease, the drug 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 conduction block or 1:1 conduction.
Rytmonorm 300 and other medicines
Tell your doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Using 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 (β-blockers, tricyclic antidepressants). Increased risk of central nervous system adverse effects of lidocaine has been reported when administered concomitantly with propafenone hydrochloride.

Rytmonorm 300 may enhance the effects of the following medicines:

Medicines metabolized by the CYP2D6 isoenzyme, such as venlafaxine,
β-Blockers, such as propranolol, metoprolol,
Antidepressants, such as desipramine,
Immunosuppressive medicines, such as cyclosporine,
Medicines used in the treatment of asthma, such as theophylline,
Cardiac glycosides, such as digoxin,
Oral anticoagulants, such as phenprocoumon, acenocoumarol, warfarin.

The following medicines may enhance the effect of Rytmonorm 300:

Antifungal medicines (e.g. ketoconazole),
Medicines used in the treatment of peptic ulcer disease (e.g. cimetidine),
Antiarrhythmic medicines (e.g. quinidine),
Antibacterial antibiotics (e.g. erythromycin),
Antidepressants belonging to the selective serotonin reuptake inhibitors (SSRIs), such as paroxetine, fluoxetine.

If these medicines are used concomitantly with Rytmonorm 300, the 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, dose adjustments of both medicines may be necessary, based on the treatment response.
Children and adolescents
Studies on the interactions between medicines have been conducted exclusively in adults. It is not known whether the range of the above 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 is planning 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 benefits to the mother outweigh the potential risks 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 operating machinery
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, driving and operating machinery should be avoided.
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 used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The doctor will determine the individual dose.
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 treatment, for patients weighing approximately 70 kg,
the recommended daily dose of propafenone hydrochloride 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
reduce the daily dose accordingly. 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
monitoring of ECG recordings and repeated blood pressure measurements (dose-adjustment 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
particular 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 impaired liver and/or kidney function
In patients with hepatic and/or renal impairment, 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 recordings and plasma drug concentration.
Use of a higher than recommended dose of Rytmonorm 300
In case of overdose, disturbances in heart function, cardiac arrest, and hypotension may occur,
and in severe cases, cardiogenic shock.
Other symptoms may 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).
Death has also been reported.
In severe cases of poisoning, tonic-clonic seizures (seizures with loss of consciousness and
contraction of all body muscles), paresthesia (tingling sensation), somnolence, coma, and
respiratory arrest may additionally occur.
In case of overdose, seek immediate medical attention at the nearest hospital.
Missed dose of Rytmonorm 300
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 disturbances, and palpitations.
The adverse reactions listed below have been reported in clinical trials and following the marketing of propafenone hydrochloride.

Very common (affects at least 1 in 10 people)

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

Common (affects 1 to 10 in 100 people)

Anxiety, sleep disorders.
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.
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 (affects 1 to 10 in 1,000 people)

Thrombocytopenia (low platelet count).
Decreased appetite, nightmares.
Syncope (fainting), ataxia (movement coordination disorder), paraesthesia (numbness, tingling).
Dizziness.
Ventricular tachycardia.
Cardiac arrhythmia.
Hypotension (low blood pressure).
Increased abdominal girth, flatulence.
Urticaria, pruritus (itching), rash, erythema.
Erectile dysfunction.

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

Agranulocytosis (complete or near-complete absence of granulocytes in blood), leukopenia (reduced white blood cell count), granulocytopenia (reduced granulocyte count).
Hypersensitivity (may manifest as cholestasis, blood dyscrasias, and rash).
Confusional state.
Seizures, extrapyramidal symptoms, akathisia (motor restlessness).
Ventricular fibrillation, heart failure (may exacerbate pre-existing heart failure), decreased heart rate.
Orthostatic hypotension (sudden drop in blood pressure upon changing from lying to standing position).
Retching, gastrointestinal disturbance.
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, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rytmonorm 300

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
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 in use. 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, corn starch, hypromellose, magnesium stearate, purified water. The film-coat contains: polyethylene glycol 400, polyethylene glycol 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.
Pack sizes of 20 or 50 film-coated tablets.
PVC/Al blisters in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, country of export:
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturer:
FAMAR LYON
Avenue du General De Gaulle
69230 Saint-Genis Laval
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, country of export: 986257.2
Parallel import authorisation number: 46/22