Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Rytmonorm 300 (Rytmonorm 300 mg)
300 mg, film-coated tablets
Propafenoni hydrochloridum
Rytmonorm 300 and Rytmonorm 300 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. This 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Rytmonorm 300 is and what it is used for
Important information before taking Rytmonorm 300
How to take Rytmonorm 300
Possible side effects
How to store Rytmonorm 300
Contents of the pack and other information

1. What Rytmonorm 300 is and what it is used for

Propafenone hydrochloride – the active substance in Rytmonorm 300 – has antiarrhythmic properties, meaning it restores or maintains normal heart rhythm. The mechanism of action 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 300 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
in severe symptomatic ventricular tachyarrhythmia, if the physician considers it life-threatening

2. Important information before using Rytmonorm 300

When not to use Rytmonorm 300

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

Page 1 of 7

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 has symptoms of fluid and 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 taking ritonavir (a medicine used in the treatment of HIV infections).

Warnings and precautions
Before starting treatment with Rytmonorm 300, 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 300 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, 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 associated 2:1 or 1:1 conduction block.
Rytmonorm 300 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 300 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 lidocaine-induced central nervous system adverse effects has been reported when lidocaine was administered concomitantly with propafenone hydrochloride.

Rytmonorm 300 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 medicines, such as digoxin
oral anticoagulants, such as phenprocoumon, acenocoumarol, warfarin

The following medicines may enhance the effect of Rytmonorm 300:

antifungal medicines (e.g. ketoconazole)

Page 2 of 7

medicines used in the treatment of gastric and duodenal ulcers (e.g. cimetidine)
antiarrhythmic medicines (e.g. quinidine)
antibacterial medicines – antibiotics (e.g. erythromycin)
antidepressants from the selective serotonin reuptake inhibitors group, such as paroxetine, fluoxetine

If these medicines are taken simultaneously with Rytmonorm 300, the doctor will monitor cardiovascular function and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when used concomitantly with Rytmonorm 300, may reduce its effectiveness:

phenobarbital
rifampicin

When treating concomitantly with amiodarone and Rytmonorm 300, dose adjustment of both medicines may be necessary, depending 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 such interactions in children and adolescents is similar to that in adults.
Rytmonorm 300 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 300 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 300 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 or operate machinery. If such symptoms occur, do not drive or operate any machinery.
Rytmonorm 300 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Rytmonorm 300

This medicine should always be used as directed by the physician. In case of doubt, consult your
physician or pharmacist.
The dosage will be individually determined by the physician.
Due to the bitter taste of propafenone and its local anaesthetic effect, the coated tablets should be
swallowed whole (without chewing), with a drink.
Page 3 of 7
Adults
During the dose-adjustment 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 physician 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 physician will consider reducing the dose.
The individual maintenance dose should be established under cardiological supervision, including
monitoring of ECG recordings and repeated blood pressure measurements (dose-adjustment phase).
Use in children
Due to its strength, Rytmonorm 300 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, starting with low doses that are progressively increased. 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 hepatic and/or renal impairment
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 recordings and plasma drug concentrations.
Use of a higher than recommended dose of Rytmonorm 300
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).
Fatal outcomes have also been reported.
In severe cases of poisoning, tonic-clonic seizures (seizures with loss of consciousness and muscle
contraction throughout the body), paresthesia (tingling sensation), somnolence, coma, and respiratory
arrest may additionally occur.
In case of overdose, seek immediate medical attention at the nearest hospital.
Missed dose of Rytmonorm 300
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The most commonly reported adverse reactions associated with propafenone hydrochloride therapy
are dizziness, conduction disturbances and palpitations.
Page 4 of 7
Below is a list of adverse reactions reported in clinical trials and following the marketing of
propafenone hydrochloride.

Very common (affects at least 1 in 10 patients)

dizziness (excluding peripheral vertigo)
disturbances in cardiac conduction
palpitations

Common (affects 1 to 10 in 100 patients)

anxiety, sleep disorders
headache, taste disturbances
blurred vision
sinus bradycardia (slow heart rate), bradycardia, tachycardia (fast heart rate), atrial flutter
dyspnea (shortness of breath)
abdominal pain, vomiting, nausea, diarrhea, 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 patients)

thrombocytopenia (low platelet count)
decreased appetite, nightmares
fainting, ataxia (movement coordination disorders), paresthesia (numbness, tingling)
dizziness
ventricular tachycardia
cardiac arrhythmia
hypotension (low blood pressure)
increased abdominal girth, flatulence
urticaria, pruritus (itching), rash, erythema (redness)
erectile dysfunction

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

agranulocytosis (complete or almost complete absence of granulocytes in 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 (may lead to worsening of 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 adverse reactions not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products,
Page 5 of 7
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 provide more information on the safety of this medicine.

5. How to store Rytmonorm 300

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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 must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Rytmonorm 300 contains

The active substance is propafenone hydrochloride. One coated tablet contains 300 mg of the active substance.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, maize starch, hypromellose, magnesium stearate, purified water. The film-coating contains: polyethylene glycol 400, polyethylene glycol 6000, hypromellose, titanium dioxide (E171).

What Rytmonorm 300 looks like and contents of the pack
Rytmonorm 300 is available as film-coated tablets. The film-coated tablet is white,
biconvex, with the imprint "300" on one side.
Pack sizes of 20 or 50 film-coated tablets.
Blister packs made of PVC/Aluminum foil in cardboard cartons.
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:
FAMAR LYON, Avenue du General De Gaulle, 69230 Saint-Genis Laval, France
ITC Farma s.r.l., Via Pontina km 29, 00071 Pomezia (RM), Italy
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 Spain, the country of export: 986257.2
Parallel Import Licence number: 411/21
Page 6 of 7
Page 7 of 7