Rytmonorm 150

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Rytmonorm 150 (Rytmonorm 150 mg)
150 mg, film-coated tablets
Propafenoni hydrochloridum
Rytmonorm 150 and Rytmonorm 150 mg are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Rytmonorm 150 is and what it is 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 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 of the drug is complex and includes, among others, stabilization of the cell membrane 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 syndrome (WPW), or paroxysmal atrial fibrillation
• for severe symptomatic ventricular tachyarrhythmia, if the physician considers it life-threatening.

2. Important 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:
• 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 shock caused by arrhythmia
• Symptomatic severe bradycardia (bradycardia)

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• Sinus node dysfunction, atrial conduction disturbances, second- or higher-degree atrioventricular (AV) block, bundle branch block or distal block in patients without a cardiac pacemaker
• Severe hypotension
• If the patient has symptoms of water-electrolyte imbalance (e.g. disturbances in 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 drugs, may cause proarrhythmic effects, i.e. it may induce new or worsen pre-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 cardiac pacemaker, the doctor will check the pacemaker function and, if necessary, reprogram it, because 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 associated 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.
Taking Rytmonorm 150 together with the following medicines may increase the risk of adverse effects:

• Local anaesthetics (e.g. during pacemaker implantation, surgical or dental procedures)
• Other medicines that reduce heart rate and/or myocardial contractility (beta-blockers, tricyclic antidepressants)
  There have been reports of increased risk of lidocaine's central nervous system side effects when used concomitantly with propafenone hydrochloride.

Rytmonorm 150 may enhance 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 enhance the effect of Rytmonorm 150:

• Antifungal medicines (e.g. ketoconazole)
• Medicines used in the treatment of gastric and duodenal ulcer (e.g. cimetidine)
• Antiarrhythmic medicines (e.g. quinidine)

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• Antibacterial antibiotics (e.g. erythromycin)
• Antidepressants which are selective serotonin reuptake inhibitors (SSRIs), such as paroxetine, fluoxetine

If these medicines are used concomitantly with Rytmonorm 150, your 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 effectiveness:

• Phenobarbital
• Rifampicin

In case of combined treatment with amiodarone and Rytmonorm 150, dose adjustments of both medicines may be necessary, based on the treatment response.
Children and adolescents
Studies on the interactions between medicines have been conducted exclusively 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 benefit to the mother outweighs the potential risk 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 position from lying to standing), may affect reaction speed and impair the ability to drive or operate machinery. If such effects occur, do not drive or operate any machinery.
Rytmonorm 150 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning that the medicine is considered "sodium-free".

3. How to use Rytmonorm 150

This medicine should always be taken exactly as recommended by your doctor. If you have any doubts,
please consult your doctor or pharmacist.
Your doctor will determine the dose individually.
Due to the bitter taste of propafenone and its local anaesthetic effect, the coated tablets should be
swallowed whole (without chewing) with a drink.
Adults
During the dose-finding period and for maintenance treatment in patients weighing approximately 70 kg,
the recommended daily dose of propafenone hydrochloride 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
continuous ECG monitoring and repeated blood pressure measurements (the dose-finding phase).
Use in children
Due to its strength, Rytmonorm 150 must not 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 muscle disease, treatment should be initiated gradually and
with particular caution, using low, incrementally increased doses. The same applies to maintenance
therapy. If an increase in dose is necessary, it may only be done after five to eight days of treatment.
Patients with impaired liver and/or kidney function
In patients with liver and/or kidney impairment, accumulation of the drug may occur after administration
of normally recommended therapeutic doses. In these patients, the doctor will individually adjust the
dose, monitoring ECG recordings and plasma drug concentrations.
Use of a higher than recommended dose of Rytmonorm 150
In case of overdose, disturbances in heart function, cardiac arrest, and hypotension may occur, and
in severe cases, cardiogenic shock.
Other possible symptoms include: metabolic acidosis (a condition involving disturbance of the body's
acid-base balance), 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
generalized muscle contractions), paresthesia (tingling sensations), somnolence, 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly reported adverse effects associated with propafenone hydrochloride treatment
are dizziness, conduction disturbances, and palpitations.
The adverse effects listed below have been reported in clinical trials and following the marketing of
propafenone hydrochloride.

Very common (affects at least 1 in 10 patients)

• dizziness (except peripheral vertigo)
• disturbances in cardiac conduction
• palpitations

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Common (affects 1 to 10 patients in 100 patients)

• anxiety, sleep disorders
• headache, taste disturbance
• blurred vision
• sinus bradycardia, bradycardia, tachycardia, atrial flutter
• dyspnoea
• 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-glutamyltransferase activity, and increased alkaline phosphatase activity in blood)
• chest pain, asthenia (weakness), fatigue, fever

Uncommon (affects 1 to 10 patients in 1,000 patients)

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (movement coordination disorders), paraesthesia (numbness, tingling)
• dizziness
• ventricular tachycardia
• cardiac arrhythmia
• hypotension
• increased abdominal circumference, flatulence
• urticaria, pruritus, 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 number of white blood cells), granulocytopenia (reduced number of granulocytes)
• hypersensitivity (may manifest as cholestasis, blood abnormalities, and rash)
• confusion
• seizures, extrapyramidal symptoms, motor restlessness
• ventricular fibrillation, heart failure (worsening of pre-existing heart failure may occur), decreased heart rate
• orthostatic hypotension (sudden drop in blood pressure related to 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

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5. How to store Rytmonorm 150

Keep this medicine out of sight and reach of children.
No special storage instructions 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack 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 coating contains: macrogol 400, macrogol 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: 20, 50 or 90 coated tablets.
Blister packs made of PVC/Aluminium in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Mylan EOOD, Office building „Serdika Offices”, Sitnyakovo Blvd., No.48, fl. 7, 1505 Sofia, Bulgaria
Manufacturer:
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, the country of export: 20020603
Parallel import authorisation number: 14/23
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