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, 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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 medicine 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 (WPW) syndrome, 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,
    • Decompensated congestive heart failure with left ventricular ejection fraction below 35%,
    • Cardiogenic shock, excluding shock caused by arrhythmia,
    • Symptomatic severe bradycardia (slow heart rate),
    • Sinus node dysfunction, atrial conduction disorders,
    • Second- or higher-degree atrioventricular (AV) block, bundle branch block, or distal block in patients without a cardiac pacemaker,
  • Severe hypotension (low blood pressure);
• If the patient has symptoms of fluid and 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 taking 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 tests and assess your clinical condition to confirm the appropriateness of treatment 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, 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 a transition from paroxysmal atrial fibrillation to atrial flutter with associated 2:1 conduction block or 1:1 conduction.

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 anesthetics (e.g. during pacemaker implantation, surgical or dental procedures),
• Other medicines that depress heart rate and/or myocardial contractility (β-blockers, tricyclic antidepressants). Increased risk of central nervous system adverse effects of lidocaine has been reported 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,
• β-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 fenprocoumon, acenocoumarol, warfarin.

The following medicines may enhance 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),
• 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.

When treating concomitantly with amiodarone and Rytmonorm 150, dose adjustments of both medicines may be necessary, based on the treatment response.

Children and adolescents
Studies on drug interactions have been conducted exclusively in adults. It is not known whether the range of such 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 her 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.
It is not known whether propafenone passes into human breast milk. 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 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 it is considered "sodium-free".

3. How to use Rytmonorm 150

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The doctor will determine the individual dose.
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 in maintenance therapy, the recommended daily dose of
propafenone hydrochloride in patients with a body weight of 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 muscle disease, treatment should be initiated
gradually with particular caution, using small, incrementally increased doses. The same applies
to maintenance therapy. If dose escalation is necessary, it may only be performed after five to
eight days of treatment.
Patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, accumulation of the drug may occur
after administration of normally recommended therapeutic doses. In such patients, the doctor
will individually adjust the dosage, monitoring the ECG trace and drug plasma 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 possible symptoms 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).
Death has 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 experiences 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 (except peripheral vertigo),
• disturbances in cardiac conduction,
• palpitations.

Common (affects 1 to 10 in 100 people)

• anxiety, sleep disturbances,
• headache, taste disturbance,
• blurred vision,
• sinus bradycardia, bradycardia, tachycardia, atrial flutter,
• dyspnoea (shortness of breath),
• abdominal pain, vomiting, nausea, diarrhoea, 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 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), paresthesia (numbness, tingling),
• dizziness,
• ventricular tachycardia,
• cardiac arrhythmias,
• hypotension (low blood pressure),
• increased abdominal girth, flatulence,
• urticaria (hives), pruritus (itching), rash, erythema (redness),
• erectile dysfunction.

Frequency not known (frequency cannot be estimated from 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 dyscrasias, and rash),
• confusion,
• seizures, extrapyramidal symptoms, akathisia (restlessness),
• ventricular fibrillation, heart failure (may exacerbate pre-existing heart failure), decreased heart rate,
• orthostatic hypotension (sudden drop in blood pressure upon changing from lying to standing position),
• 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 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, Tel.: +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 this medicine.

5. How to store Rytmonorm 150

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine 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. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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, maize starch, hypromellose, magnesium stearate, purified water. The film-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 in the form of coated tablets. The coated tablet is white,
biconvex on both sides, with the imprint "150" on one side.
Pack sizes: 20, 50 or 90 coated tablets.
PVC/Aluminum blisters in cardboard packaging.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, the country of export:
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer:
ITC Farma s.r.l.
Via Pontina km 29
00071 Pomezia (RM)
Italy

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

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
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation number in Spain, the country of export: 986240.4
Parallel Import Licence number: 440/22