Ritmonorm

Package Leaflet: Information for the Patient

Rytmonorm, 3.5 mg/ml, Solution for Injection

Propafenone Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication 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 package leaflet, they should inform their doctor or nurse. See section 4.

Package Leaflet Contents

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

1. What is Rytmonorm and what is it used for

Propafenone hydrochloride, the active substance of Rytmonorm, has antiarrhythmic properties, i.e., it restores or maintains a normal heart rhythm. The mechanism of action of the medication 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 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.

Warning.Rytmonorm solution for injection is intended for use only in a hospital setting.

2. Important information before using Rytmonorm

When not to use Rytmonorm

• If the patient is allergic to the active substance or any of the other ingredients of this medication (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 medication used to treat HIV infections) concomitantly.

Warnings and precautions

Before starting treatment with Rytmonorm, the patient should discuss it with their doctor. Propafenone, like other antiarrhythmic medications, may cause proarrhythmic effects, i.e., may induce new or exacerbate existing arrhythmias (see section 4).

• 4)

Before starting treatment with Rytmonorm and during treatment, the doctor will order ECG tests and assess the patient's clinical condition to determine whether the response to the medication justifies its use and to rule out Brugada syndrome (a genetically determined heart disease).

Particular caution is required:

• in patients with an implanted pacemaker, the doctor will check the pacemaker's function and, if necessary, reprogram it, as the medication may affect the stimulation threshold and sensitivity of the implanted pacemaker;
• in patients with clinically significant structural heart disease, the medication is contraindicated;
• in patients with asthma.

In some patients, the medication may cause paroxysmal atrial fibrillation to transition to atrial flutter with a 2:1 or 1:1 conduction block.

Rytmonorm and other medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Concomitant use of Rytmonorm with the following medications may enhance side effects:

• local anesthetics (e.g., during pacemaker implantation, surgery, or dental procedures),
• other medications that slow the heart rate and/or contractility (beta-adrenergic blockers, tricyclic antidepressants). There have been reports of increased risk of lidocaine's adverse effects on the central nervous system when used with propafenone hydrochloride.

Rytmonorm may enhance the effects of the following medications:

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

The following medications may enhance the effects of Rytmonorm:

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

If these medications are used concomitantly with Rytmonorm, the doctor will monitor the patient's cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride.

The following medications may reduce the effectiveness of Rytmonorm:

• phenobarbital,
• rifampicin.

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

Children and adolescents

Studies on the effects of one medication on the results of another medication 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 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 using this medication.

Rytmonorm 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 using Rytmonorm in breastfeeding women.

Driving and operating machinery

This does not apply, as the medication is used only in a hospital setting.

3. How to use Rytmonorm

This medication should always be used as directed by the doctor. In case of doubts, consult a doctor or nurse.

The dose of Rytmonorm is determined individually by the doctor for each patient to achieve optimal therapeutic effects. The patient's cardiovascular system should be monitored by ECG and blood pressure measurement.

During infusion, the ECG recording (QRS complex, PR interval, and QTc interval) and blood flow parameters should be closely monitored.

The recommended single dose is 1 mg/kg body weight. The desired therapeutic effect often occurs after administration of a dose of 0.5 mg/kg body weight. If necessary, the doctor may increase the single dose to 2 mg/kg body weight.

Treatment should be started with the smallest possible dose, carefully observing the patient and monitoring the ECG and blood pressure.

Intravenous injection should be performed slowly over 3 to 5 minutes. The interval between consecutive injections should not be less than 90 to 120 minutes.

If the QRS complex widens or the QT interval lengthens by more than 20% in a frequency-dependent manner, the injection should be stopped immediately.

Short-term infusion

If propafenone hydrochloride is administered as a short-term infusion lasting from 1 to 3 hours, the recommended infusion rate is 0.5 to 1 mg/min.

Slow infusion

If propafenone hydrochloride is administered as a slow infusion, the maximum recommended daily dose is 560 mg.

To prepare the infusion solution, a glucose or fructose solution (5%) should be used.

Isotonic sodium chloride solution should not be used for this purpose, as it may cause the medication to precipitate out of the solution.

Using a higher dose of Rytmonorm than recommended

In case of administration of too high a dose of Rytmonorm, the patient should be under constant clinical observation. Appropriate symptomatic treatment should be applied.

In case of overdose, arrhythmias, cardiac arrest, and hypotension may occur, as well as metabolic acidosis (a state of acid-base imbalance in the body), headaches, dizziness, blurred vision, sensory disturbances (tingling, numbness, prickling) of the hands or feet, tremors, nausea, constipation, dry mouth, and seizures (convulsions).

Death has also been reported.

In severe cases of poisoning, additional symptoms may include tonic-clonic seizures (seizures with loss of consciousness and muscle contractions throughout the body), paresthesia (tingling sensation), somnolence, coma, and respiratory arrest.

Treatment

Besides the general measures used in emergency situations, the patient's vital signs should be monitored in an intensive care unit and, if necessary, normalized.

Defibrillation and administration of dopamine and isoproterenol by infusion have been shown to be effective in controlling heart rhythm and blood pressure.

Seizures can be controlled by administering diazepam intravenously.

It may be necessary to use general supportive measures to maintain vital functions, such as mechanical ventilation and external cardiac massage.

Attempts to eliminate the medication by hemoperfusion have limited effectiveness.

Due to the high degree of binding to proteins (95%) and large volume of distribution, hemodialysis is ineffective.

Missing a dose of Rytmonorm

A double dose should not be used to make up for a missed dose.

Stopping treatment with Rytmonorm

The doctor will decide when to stop using Rytmonorm in the form of a solution for injection.

4. Possible side effects

Like all medications, Rytmonorm 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 medications containing propafenone hydrochloride.

Very common(in at least 1 in 10 patients)

• Dizziness (excluding peripheral vertigo).
• 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.
• Dyspnea.
• 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.
• Arrhythmias.
• Hypotension.
• Increased abdominal circumference, bloating with gas passage.
• 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 (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.
• Atrial fibrillation, heart failure (may worsen existing heart failure), decreased heart rate.
• Orthostatic hypotension (sudden drop in blood pressure, related to changing position from lying to standing).
• Vomiting, gastrointestinal disorders.
• Liver cell damage, cholestasis, hepatitis, jaundice.
• Systemic lupus erythematosus-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 package 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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 medication.

5. How to store Rytmonorm

The medication should be stored out of sight and reach of children.

Do not store in the refrigerator or freeze.

Do not use this medication 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 specified month.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rytmonorm contains

The active substance of Rytmonorm is propafenone hydrochloride. 1 ml of the solution contains 3.5 mg of the active substance.

The other ingredients are: glucose monohydrate, water for injections.

What Rytmonorm looks like and what the package contains

Rytmonorm is packaged in colorless glass ampoules.

The package (cardboard box) contains 5 ampoules of 20 ml each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Sp. z o.o.

ul. Postępu 21B

02-676 Warsaw

Manufacturer

Famar Health Care Services Madrid S.A.U.

Avda. de Leganés, 62

28923 Alcorcón-Madrid

Spain

To obtain more detailed information, please 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 package leaflet:02/2024