Ritmonorm 150

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Rytmonorm 150 (Rytmonorm 150 mg)

150 mg, Coated Tablets

Propafenone Hydrochloride
Rytmonorm 150 and Rytmonorm 150 mg are different trade names for the same drug.

You Should Carefully Read the Contents of the Leaflet Before Using the Drug, as it Contains Important Information for the Patient.

• You should 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 drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rytmonorm 150 and what is it used for
• 2. Important information before taking Rytmonorm 150
• 3. How to take Rytmonorm 150
• 4. Possible side effects
• 5. How to store Rytmonorm 150
• 6. Contents of the packaging and other information

1. What is Rytmonorm 150 and what is it used for

Propafenone hydrochloride, the active substance of Rytmonorm 150, has antiarrhythmic properties, meaning 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 150 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 150

When not to take Rytmonorm 150

• If the patient is allergic to the active substance or any of the other ingredients of this drug (listed in section 6).
• If the patient has:
• Brugada syndrome
• a 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
• symptomatic severe bradycardia (bradycardia)
• disturbances of sinoatrial node function, 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 drug used to treat HIV infections) at the same time.

Warnings and precautions

Before starting to take Rytmonorm 150, you should discuss it with your doctor. Propafenone, like other antiarrhythmic drugs, may cause proarrhythmic effects, i.e., it may induce new or exacerbate existing heart rhythm disturbances (see section 4). Before starting treatment with Rytmonorm 150 and during treatment, the doctor will order an ECG 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

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

Rytmonorm 150 and other drugs

You should tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take. Taking Rytmonorm 150 with the following drugs may increase the risk of side effects:

• local anesthetics (e.g., during pacemaker implantation, surgery, or dental procedures)
• other drugs that slow the heart rate and/or contractility of the heart muscle (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 150 may increase the effect of the following drugs:

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

The following drugs may increase the effect of Rytmonorm 150:

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

If these drugs are taken at the same time as Rytmonorm 150, the doctor will monitor the cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride. The following drugs, when used with Rytmonorm 150, may reduce its effectiveness:

• phenobarbital
• rifampicin

In the case of combined treatment with amiodarone and Rytmonorm 150, it may be necessary to adjust the doses of both drugs, taking into account the response to treatment.

Children and adolescents

Studies on the effect of one drug on the results of another drug 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 150 and drinking

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this drug. Rytmonorm 150 can be used during pregnancy only if the benefits to the mother outweigh the potential risk to the fetus. There have been no studies on the passage of propafenone into breast milk. Limited data indicate that propafenone may pass into breast milk. Caution should be exercised when using Rytmonorm 150 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 speed and impair the ability to drive vehicles and operate machinery. If they occur, you should not drive vehicles or operate any machinery.

Rytmonorm 150 contains sodium

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

3. How to take Rytmonorm 150

This drug should always be taken according to the doctor's instructions. In case of doubts, you should consult a 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. AdultsDuring the dose adjustment period and in maintenance treatment, 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 there is a significant widening of the QRS complex or a second- or third-degree atrioventricular block, the doctor will consider reducing the dose. The individual maintenance dose should be determined under cardiac control, including ECG monitoring and repeated measurement of blood pressure (dose adjustment phase). Use in childrenRytmonorm 150, due to its strength, cannot be used in children. Elderly patientsIn 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 disordersIn patients with liver and/or kidney failure, accumulation of the drug may occur after administration of the usual therapeutic doses. In these patients, the doctor will individually adjust the dosage, monitoring the ECG and the concentration of the drug in the blood.

Using a higher than recommended dose of Rytmonorm 150

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). Additionally, death has 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, you should immediately go to the nearest hospital.

Missing a dose of Rytmonorm 150

You should not take a double dose to make up for a missed dose of the drug. In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug may 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 introduction of propafenone hydrochloride to the market. 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 (numbness, 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 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, related to a change in position from lying to standing)
• nausea, 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Rytmonorm 150

The drug should be stored in a place that is out of sight and reach of children. There are no special recommendations for storing the drug. Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rytmonorm 150 contains

• The active substance of the drug is propafenone hydrochloride. One coated tablet contains 150 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 (E 171).

What Rytmonorm 150 looks like and what the packaging contains

Rytmonorm 150 is available in the form of coated tablets. The coated tablet is white, biconvex, with the inscription "150" on one side. The packaging contains 20 or 90 coated tablets. PVC/Aluminum blisters, in a cardboard box. Not all pack sizes may be marketed. For more detailed information, you 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

ITC Farma S.R.L., Via Pontina Km 29, 00071 Pomezia (RM), Italy

Parallel importer:

Aga Kommerz spol. s r.o. Frydecka 2006, 737 01 Czeski Cieszyn, Czech Republic

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY ul. Wł. Żeleńskiego 45 31-353 Kraków Spanish marketing authorization number:986240.4

Parallel import authorization number: 262/24

Date of leaflet approval: 28.06.2024

[Information about the trademark]