Ritmonorm 300

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Rytmonorm 300 (Rytmonorm 300 mg)

300 mg, coated tablets

Propafenone hydrochloride
Rytmonorm 300 and Rytmonorm 300 mg are different trade names for the same drug.

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Rytmonorm 300 and what is it used for
• 2. Important information before taking Rytmonorm 300
• 3. How to take Rytmonorm 300
• 4. Possible side effects
• 5. How to store Rytmonorm 300
• 6. Package contents and other information

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

Propafenone hydrochloride, the active substance of Rytmonorm 300, has antiarrhythmic properties, i.e., it restores or maintains a normal heart rhythm. The mechanism of action of the drug is complex and involves, among other things, stabilizing the cell membrane and blocking sodium channels. Propafenone hydrochloride also has a weak beta-adrenergic blocking effect. Rytmonorm 300 is indicated:

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

2. Important information before taking Rytmonorm 300

When not to take Rytmonorm 300

• If the patient is allergic to the active substance 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 congestive heart failure, with a left ventricular ejection fraction below 35%
• cardiogenic shock, except for shock caused by arrhythmia

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• symptomatic severe bradycardia (bradycardia)
• disturbances of sinoatrial node function, atrioventricular conduction disturbances, second- or third-degree atrioventricular block, bundle branch block, or distal block in patients without a pacemaker
• severe hypotension
• If the patient has symptoms of water-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 drug used to treat HIV infections) concomitantly.

Warnings and precautions

Before starting to take Rytmonorm 300, the patient should discuss it with their doctor. Propafenone, like other antiarrhythmic drugs, may cause proarrhythmic effects, i.e., it may induce new or exacerbate existing arrhythmias (see section 4). Before starting treatment with Rytmonorm 300 and during treatment, the doctor will order ECG tests and assess the patient's clinical condition to determine whether the response to the drug justifies its use and to rule out Brugada syndrome (a genetically determined heart disease). Particular caution should be exercised:

• in patients with an implanted pacemaker, the doctor will check the pacemaker's function and, if necessary, reprogram it, as 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

Some patients may experience a transition from paroxysmal atrial fibrillation to atrial flutter with a 2:1 or 1:1 conduction block.

Rytmonorm 300 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Concomitant use of Rytmonorm 300 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 contractility (beta-adrenergic blockers, tricyclic antidepressants) There have been reports of increased risk of lidocaine's central nervous system side effects when used with propafenone hydrochloride.

Rytmonorm 300 may increase the effects of the following medicines:

• drugs metabolized by the CYP2D6 isoenzyme, such as venlafaxine
• beta-adrenergic blockers, such as propranolol, metoprolol
• antidepressants, such as desipramine
• immunosuppressants, such as cyclosporine
• asthma medications, such as theophylline
• cardiac glycosides, such as digoxin
• oral anticoagulants, such as phenprocoumon, acenocoumarol, warfarin

The following medicines may increase the effects of Rytmonorm 300:

• antifungal agents (e.g., ketoconazole)

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• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine)
• antiarrhythmic agents (e.g., quinidine)
• antibiotics (e.g., erythromycin)
• selective serotonin reuptake inhibitors, such as paroxetine, fluoxetine

If these medicines are used concomitantly with Rytmonorm 300, the doctor will monitor the patient's cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride. The following medicines may decrease the effectiveness of Rytmonorm 300:

• phenobarbital
• rifampicin

In the case of combined treatment with amiodarone and Rytmonorm 300, it may be necessary to adjust the doses of both medicines, taking into account the response to treatment.

Children and adolescents

Studies on the effects of one medicine on the results of another medicine have been conducted only in adults. It is not known whether the range of these interactions in children and adolescents is similar to that in adults.

Rytmonorm 300 and grapefruit juice

Grapefruit juice may increase the concentration of propafenone hydrochloride in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Rytmonorm 300 can be used during pregnancy only if the benefits to the mother outweigh the potential risk to the fetus. There is limited data on the passage of propafenone into breast milk. Propafenone may pass into breast milk. Caution should be exercised when using Rytmonorm 300 in breastfeeding women.

Driving and using machines

Certain 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 time and impair the ability to drive vehicles and operate machinery. If these symptoms occur, the patient should not drive or operate machinery.

Rytmonorm 300 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Rytmonorm 300

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine the dose individually. Due to the bitter taste of propafenone and its surface anesthetic effect, the coated tablets should be swallowed whole (without chewing), with a liquid. Page 3 7
Adults
In the dose titration period and in 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 two or three divided doses. Sometimes it may be necessary to increase the daily dose of propafenone hydrochloride to 900 mg. In patients with a lower body weight, the doctor will reduce the daily dose accordingly. The dose can be increased only after 3 to 4 days of treatment. If significant QRS complex widening or second- or third-degree atrioventricular block occurs, 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).
Use in children
Rytmonorm 300, due to its strength, cannot be used in children.
Elderly patients
In elderly patients or 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, gradually increasing doses. The same applies to maintenance treatment. If a dose increase is necessary, it can be done only after 5 to 8 days of treatment.
Patients with liver and/or kidney function disorders
In patients with liver and/or kidney failure, accumulation of the medicine may occur after administration of the usual therapeutic doses. In these patients, the doctor will individually adjust the dosage, monitoring the ECG and serum concentration of the medicine.

Overdose of Rytmonorm 300

In case of overdose, cardiac arrhythmias, cardiac arrest, and hypotension may occur, as well as metabolic acidosis (a condition of acid-base imbalance in the body), headaches, dizziness, blurred vision, sensory disturbances (burning, tingling, numbness) of the hands or feet, tremors, 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 muscle contractions throughout the body), paresthesia (tingling), drowsiness, coma, and respiratory arrest may also occur. In case of overdose, the patient should immediately go to the nearest hospital.

Missed dose of Rytmonorm 300

A double dose should not be taken to make up for a missed dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rytmonorm 300 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. Page 4 7
The following side effects have been reported in clinical trials and after the marketing of propafenone hydrochloride.
Very common(in at least 1 in 10 patients)

• dizziness (except for peripheral dizziness)
• conduction disturbances in the heart
• palpitations

Common(in 1 to 10 patients out of 100 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, asthenia (weakness), fatigue, fever

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

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (coordination disorders), paresthesia (tingling)
• dizziness
• ventricular tachycardia
• arrhythmias
• hypotension
• increased abdominal circumference, bloating with gas
• hives, itching, rash, flushing
• erectile dysfunction

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

• agranulocytosis (complete or almost complete absence of granulocytes in the blood), leukopenia (decreased white blood cell count), granulocytopenia (decreased granulocyte count)
• hypersensitivity (may manifest as cholestasis, abnormal blood composition, and rash)
• confusional state
• seizures, extrapyramidal symptoms, 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)
• retching, gastrointestinal disorders
• liver cell damage, cholestasis, hepatitis, jaundice
• lupus-like syndrome
• pustular skin eruptions
• decreased sperm count (reversible after discontinuation of propafenone)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rytmonorm 300

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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. Package contents and other information

What Rytmonorm 300 contains

• The active substance of the medicine is propafenone hydrochloride. One coated tablet contains 300 mg of the active substance.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, cornstarch, hypromellose, magnesium stearate, purified water. The coating contains: macrogol 400, macrogol 6000, hypromellose, titanium dioxide (E171).

What Rytmonorm 300 looks like and what the package contains

Rytmonorm 300 is available in the form of coated tablets. The coated tablet is white, biconvex, with the inscription "300" on one side. The package contains 20 or 50 coated tablets. Blisters of PVC/Al in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Manufacturer:

FAMAR LYON, Avenue du General De Gaulle, 69230 Saint-Genis Laval, France
ITC Farma s.r.l., Via Pontina km 29, 00071 Pomezia (RM), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export authorization number: 986257.2

Parallel import authorization number: 411/21

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Date of leaflet approval: 18.01.2022
[Information about the trademark]
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