Ritmonorm 300

Leaflet attached to the packaging: patient information

Rytmonorm 300, 300 mg, coated tablets

Propafenone hydrochloride

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 inform their doctor or pharmacist. 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 anti-arrhythmic properties, i.e., it restores or maintains a normal heart rhythm. The mechanism of action of the medicine 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 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 to take Rytmonorm 300, the patient should discuss it with their doctor.
Propafenone, like other anti-arrhythmic medicines, may cause pro-arrhythmic effects, i.e., it may induce new or exacerbate existing heart rhythm disturbances (see section 4).

• 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 medicine 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 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 paroxysmal atrial fibrillation to transition 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.
Taking 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:

• medicines metabolized by the CYP2D6 isoenzyme, such as venlafaxine,
• beta-adrenergic blockers, such as propranolol, metoprolol,
• antidepressants, such as desipramine,
• immunosuppressants, 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 effects of Rytmonorm 300:

• antifungal medicines (e.g., ketoconazole),
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine),
• anti-arrhythmic medicines (e.g., quinidine),
• antibacterial medicines (e.g., erythromycin),
• antidepressants from the selective serotonin reuptake inhibitor group, such as paroxetine, fluoxetine.

If these medicines are taken at the same time as Rytmonorm 300, the doctor will monitor the patient's cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when taken with Rytmonorm 300, may reduce its effectiveness:

• 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 scope 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, 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.
It has not been studied whether propafenone passes into breast milk. Limited data suggest that propafenone may pass into breast milk. Caution should be exercised when taking Rytmonorm 300 in breastfeeding women.

Driving and operating machinery

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 time and impair the ability to drive and operate machinery. If these occur, the patient should not drive or operate any 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 of the medicine 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.
Adults
During 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.
In case of significant QRS complex widening or 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).
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, after administration of the usual therapeutic doses, the medicine may accumulate. In these patients, the doctor will individually select the dosage of the medicine, monitoring the ECG and serum concentration of the medicine.

Using a higher than recommended dose of Rytmonorm 300

In case of overdose, heart rhythm disturbances, cardiac arrest, and hypotension may occur, as well as, in severe cases, cardiogenic shock.
The following may also occur: metabolic acidosis (a state of acid-base imbalance in the body), headache, dizziness, blurred vision, sensory disturbances (tingling, prickling, numbness) of the hands or feet, tremor, nausea, constipation, dry mouth, and seizures (convulsions).
Death has also been reported.
In severe cases of poisoning, the following may also occur: tonic-clonic seizures (seizures with loss of consciousness and muscle contraction throughout the body), paresthesia (tingling sensation), drowsiness, coma, and respiratory arrest.
In case of overdose, the patient should immediately go to the nearest hospital.

Missing a dose of Rytmonorm 300

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

4. Possible side effects

Like all medicines, this medicine 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.
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 sensation).
• Dizziness.
• Ventricular tachycardia.
• Heart rhythm disturbances.
• 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 (decrease in the number of white blood cells), granulocytopenia (decrease in the number of granulocytes).
• Hypersensitivity (may manifest as cholestasis, abnormal blood count, 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, associated with a change in position from lying to standing).
• Vomiting reflex, gastrointestinal disturbance.
• Liver cell damage, cholestasis, hepatitis, jaundice.
• Lupus-like syndrome.
• Pustular skin eruptions.
• Decreased sperm count (reversible after discontinuation of propafenone).

Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Rytmonorm 300

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging after the words "Expiry date" or "EXP". The expiry date refers to the last day of the month.
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, pregelatinized starch, 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.

Available packages:

20 tablets – 2 blisters of 10 tablets each.
50 tablets – 5 blisters of 10 tablets each.
Blisters made of PVC/Aluminum foil, in a cardboard box .

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information, the patient should contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Tel: 22 546 64 00
Date of last revision of the leaflet:02/2024