Rytmonorm 150

Package leaflet: Information for the patient

Warning! Keep this 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 for the same medicinal product.
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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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. 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 (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 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, except 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 cardiac pacemaker
• Severe hypotension
• If the patient shows symptoms of water-electrolyte imbalance (e.g. disorders of potassium metabolism).
• In case of severe obstructive lung disease.
• In patients with myasthenia (a disease characterized by muscle weakness).
• If the patient is concurrently 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 arrhythmias or worsen pre-existing rhythm disorders (see section 4).
Before starting treatment with Rytmonorm 150 and during therapy, your doctor will order
ECG examinations and assess the patient's clinical status 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, 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 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 inhibit heart rate and/or myocardial contractility (beta-blockers, tricyclic antidepressants)
  Increased risk of lidocaine's central nervous system adverse effects has been reported when lidocaine was administered concomitantly with propafenone hydrochloride.

Rytmonorm 150 may enhance the effects of the following medicines:
medicines metabolized by CYP2D6 isoenzyme, such as venlafaxine

• Beta-blocking agents, such as propranolol, metoprolol
• Antidepressants, such as desipramine
• Immunosuppressive medicines, such as cyclosporine
• Medicines used in asthma treatment, such as theophylline
• Cardiac glycosides, such as digoxin
• Oral anticoagulants, such as fenoprocoumon, 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 ulcers (e.g. cimetidine)
• Antiarrhythmic medicines (e.g. quinidine)
• Antibacterial antibiotics (e.g. erythromycin)
• Antidepressants from the selective serotonin reuptake inhibitors group, 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 effectiveness:

• Phenobarbital
• Rifampicin

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

Children and adolescents
Studies on the influence of one medicine on the effects of another have been conducted exclusively in adults. It is not known whether the range of the above interactions in children and adolescents is similar to that in adults.

Rytmonorm 150 and grapefruit juice
Grapefruit juice may increase blood concentrations 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 (sudden drop in blood pressure upon changing position from lying to standing) may affect reaction speed and impair the ability to drive vehicles or operate machinery. If such effects occur, the patient should not drive or operate any machinery.

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

3. How to use Rytmonorm 150

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The physician will determine the dose individually.
Due to the bitter taste of propafenone and its local anesthetic effect, the coated tablets should be
swallowed whole (without chewing) with liquid.
Adults
During the dose-adjustment period and in maintenance therapy, 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 physician will
appropriately reduce the daily dose. 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 physician will consider reducing the dose.
The individual maintenance dose should be established under cardiological supervision, including
continuous ECG monitoring and repeated blood pressure measurements (dose-adjustment phase).
Use in children
Due to its potency, 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 disease, treatment should be initiated gradually and with
particular caution, starting with low doses that are progressively increased. The same applies to
maintenance therapy. If dose escalation is necessary, it may be done only after five to eight days
of treatment.
Patients with impaired liver and/or kidney function
In patients with hepatic and/or renal impairment, accumulation of the drug may occur after
administration of normally recommended therapeutic doses. In these patients, the physician will
individually adjust the dosage, monitoring ECG tracings 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 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, additional symptoms may include tonic-clonic seizures (seizures with
loss of consciousness and generalized muscle contractions), paresthesia (tingling sensation),
drowsiness, coma, and respiratory arrest.
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 doubts concerning 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 observed adverse reactions associated with propafenone hydrochloride treatment are dizziness, conduction disturbances, and palpitations.
The adverse reactions listed below were reported in clinical trials and following the marketing of propafenone hydrochloride.

Very common (affects at least 1 in 10 people)

• dizziness (excluding peripheral vertigo)
• disturbances in cardiac impulse conduction
• palpitations

Common (affects 1 to 10 people in 100 people)

• anxiety, sleep disorders
• 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
• abnormal liver function (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 people in 1,000 people)

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (impaired coordination of movements), paraesthesia (numbness, tingling sensations)
• dizziness
• ventricular tachycardia
• cardiac arrhythmia
• hypotension (low blood pressure)
• increased abdominal girth, flatulence
• urticaria, itching, rash, erythema
• erectile dysfunction

Frequency not known (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 dyscrasias, and rash)
• confusion
• seizures, extrapyramidal symptoms, motor restlessness
• ventricular fibrillation, heart failure (existing heart failure may worsen), 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 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 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 requirements for storage conditions.
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 measures help protect the environment.

6. Contents of the packaging and other information

What Rytmonorm 150 contains

• The active substance is propafenone hydrochloride. Each 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 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 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 or 90 coated tablets.
Blister packs made of PVC/Aluminum, in a cardboard carton.
Not all pack sizes may be marketed.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, 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:
Aga Kommerz spol. s r.o.
Frydecka 2006, 737 01 Czesky Tesin, Czech Republic

Repackaged in:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Manufactured by Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków

Marketing Authorisation Number in Spain, country of export: 986240.4
Parallel Import Licence Number: 262/24