Rytmonorm 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
Propafenoni hydrochloridum
Rytmonorm 150 and Rytmonorm 150 mg are different trade names of the same medicinal product.
Please read carefully the entire leaflet before using the medicinal product, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicinal product has been prescribed for a specific individual. Do not pass it on to others. The medicinal product may harm another person, 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.

Table of contents of the leaflet

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

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

Propafenone hydrochloride – the active substance in Rytmonorm 150 – has antiarrhythmic properties, meaning it restores or maintains normal heart rhythm. The mechanism of action is complex and includes, among others, cell membrane stabilization and blockade of sodium channels. Propafenone hydrochloride also exhibits weak β-adrenolytic activity.
Rytmonorm 150 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, if the physician considers it life-threatening.

2. Information before using Rytmonorm 150

When not to use Rytmonorm 150

• 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 water-electrolyte imbalance (e.g. disorders of potassium metabolism).
  • In case of severe obstructive lung disease.
  • In patients with myasthenia gravis (a disease characterized by muscle weakness).
  • If the patient is concurrently using ritonavir (a medicine used in the treatment of HIV infections).

Warnings and precautions
Before starting treatment with Rytmonorm 150, discuss this with your doctor.
Propafenone, like other antiarrhythmic medicines, may cause proarrhythmic effects,
i.e. it may induce new or worsen previously existing cardiac arrhythmias (see section 4).
Before starting treatment with Rytmonorm 150 and during treatment, your doctor will order
ECG examinations and assess your clinical condition to determine whether the response to
the medicine justifies its continued use and to exclude Brugada syndrome (a genetically
determined heart disease).
Special caution is required:

• In patients with an implanted pacemaker, the doctor will check pacemaker 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 conversion of paroxysmal atrial fibrillation into
atrial flutter with 2:1 or 1:1 conduction block.

Rytmonorm 150 and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Using Rytmonorm 150 together with the following medicines may increase the risk of adverse effects:

• Local anesthetics (e.g. during pacemaker implantation, surgical or dental procedures)
• Other medicines that reduce heart rate and/or myocardial contractility (beta-blockers, tricyclic antidepressants). Increased risk of central nervous system adverse effects of lidocaine has been reported when administered concomitantly with propafenone hydrochloride.

Rytmonorm 150 may increase the effects of the following medicines:

• Medicines metabolized by the CYP2D6 isoenzyme, such as venlafaxine
• Beta-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 increase the effect of Rytmonorm 150:

• 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 from the group of selective serotonin reuptake inhibitors, such as paroxetine, fluoxetine.

If these medicines are used concomitantly with Rytmonorm 150, the doctor will monitor
cardiovascular function and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when used concomitantly with Rytmonorm 150, may reduce its efficacy:

• Phenobarbital
• Rifampicin

When treating concomitantly with amiodarone and Rytmonorm 150, it may be necessary
to adjust the doses of both medicines according to the treatment response.

Children and adolescents
Studies on the influence of one medicine on the effects of another 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 150 and grapefruit juice
Grapefruit juice may increase blood levels 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 150 may be used during pregnancy only if the benefits to the mother outweigh the
potential risks to the fetus.
Excretion of propafenone into human breast milk has not been studied. Limited data suggest that propafenone may pass into breast milk. Caution should be exercised when administering Rytmonorm 150 to breastfeeding women.

Driving and operating machinery
Some adverse effects, such as blurred vision, dizziness, fatigue, and orthostatic hypotension (a sudden drop in blood pressure upon changing from lying to standing position) may affect reaction speed and impair the ability to drive and operate machinery. If such symptoms occur, do not drive or operate any machinery.

Rytmonorm 150 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Rytmonorm 150

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The doctor will determine the dosage individually.
Due to the bitter taste of propafenone and its local anaesthetic effect, the coated tablets
should be swallowed whole (without chewing) with liquid.
Adults
During the dose-finding period and in maintenance treatment, the recommended daily dose of propafenone hydrochloride in patients weighing approximately 70 kg 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 ECG monitoring and repeated blood pressure measurements (dose-finding phase).
Use in children
Due to its strength, Rytmonorm 150 cannot 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 and with particular caution, using small, incrementally increased doses. The same applies to maintenance treatment. If dose escalation is necessary, it may be performed only after five to eight days of treatment.
Patients with impaired liver and/or kidney function
In patients with hepatic and/or renal impairment, drug accumulation may occur after administration of normally recommended therapeutic doses. In these patients, the doctor will individually adjust the dosage, monitoring the ECG and plasma drug concentration.
Use of a higher than recommended dose of Rytmonorm 150
In case of overdose, disturbances in heart function, cardiac arrest, hypotension, and in severe cases, cardiogenic shock may occur.
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).
Fatal outcomes have also been reported.
In severe cases of poisoning, tonic-clonic seizures (seizures with loss of consciousness and muscle contractions throughout the body), paraesthesia (tingling sensation), drowsiness, coma, and respiratory arrest may additionally occur.
In case of overdose, seek immediate medical attention at the nearest hospital.
Missed dose of Rytmonorm 150
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, 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 disturbances
• headache, taste disturbance
• blurred vision
• sinus bradycardia (slow heart rate), bradycardia, tachycardia (fast heart rate), atrial flutter
• shortness of breath
• abdominal pain, vomiting, nausea, diarrhoea, constipation, dry mouth
• liver function abnormalities (abnormal liver function tests such as increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased gamma-glutamyl transferase 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
• fainting, ataxia (impaired coordination), paraesthesia (numbness, tingling)
• dizziness
• ventricular tachycardia
• cardiac arrhythmia
• hypotension (low blood pressure)
• increased abdominal girth, flatulence
• urticaria, itching, rash, erythema
• erectile dysfunction

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

• agranulocytosis (complete or near-complete absence of granulocytes in the blood), leukopenia (reduced white blood cell count), granulocytopenia (reduced granulocyte count)
• hypersensitivity (may manifest as cholestasis, blood abnormalities, and rash)
• confusion
• seizures, extrapyramidal symptoms, motor restlessness
• ventricular fibrillation, heart failure (may exacerbate pre-existing heart failure), decreased heart rate
• orthostatic hypotension (sudden drop in blood pressure associated with changing position from lying to standing)
• vomiting reflex, gastrointestinal disturbances
• liver cell damage, 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 be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rytmonorm 150

Keep this medicine out of sight and reach of children.
No special storage conditions are required.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Rytmonorm 150 contains

• The active substance is propafenone hydrochloride. One coated tablet contains 150 mg of the active substance.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, pregelatinized starch, hypromellose, magnesium stearate, purified water. The film-coating contains: polyethylene glycol 400, polyethylene glycol 6000, hypromellose, titanium dioxide (E 171).

What Rytmonorm 150 looks like and contents of the pack
Rytmonorm 150 is available as coated tablets. The coated tablet is white,
biconvex, with the imprint "150" on one side.
Pack sizes contain 20, 50 or 90 coated tablets.
Blister packs made of PVC/Aluminium, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, country of export:
Viatris SIA
Mūkusalas 101
LV 1004 Riga
Latvia
Manufacturer:
Mylan Hungary Kft.
Mylan utca 1
Komárom 2900
Hungary
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
Poland
Marketing authorisation number in Lithuania, country of export: LT/1/94/1020/001
Parallel import authorisation number: 60/26