RYTMONORM 150

Package leaflet: Information for the patient

Warning! Keep this leaflet. The 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 brand names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a 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, 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 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

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• 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 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 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 the patient's 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
You must 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.
Using Rytmonorm 150 together with the following medicines may increase adverse effects:

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

Rytmonorm 150 may increase the effects of the following medicines:

• Medicines metabolized by CYP2D6 isoenzyme, such as venlafaxine
• β-Blockers, 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 phenprocoumon, acenocoumarol, warfarin

The following medicines may increase the effect of Rytmonorm 150:

• Antifungal medicines (e.g. ketoconazole)

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• Medicines used in the treatment of peptic ulcer disease (e.g. cimetidine)
• Antiarrhythmic medicines (e.g. quinidine)
• Antibacterial antibiotics (e.g. erythromycin)
• Antidepressants which are 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 effectiveness:

• Phenobarbital
• Rifampicin

In case of combined treatment with amiodarone and Rytmonorm 150, dose adjustment of both medicines may be required, based on 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 the above 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.
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 (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, the patient should not drive or operate any machinery.
Rytmonorm 150 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 150

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The dosage will be individually determined by the doctor.
Due to the bitter taste of propafenone and its local anaesthetic effect, the coated tablets
should be swallowed whole (without chewing) with liquid.
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Adults
During the dose-adjustment period and in maintenance treatment, the recommended daily dose of
propafenone hydrochloride in patients weighing approximately 70 kg is 450 to 600 mg, given 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
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 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-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 with
particular caution, using small 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 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 such patients, the doctor will
individually adjust the dosage, monitoring the ECG and plasma concentration of the drug.
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 symptoms may include: metabolic acidosis (a condition of disturbed acid-base balance in the
body), headache, dizziness, blurred vision, sensory disturbances (burning, prickling, tingling) in the
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
generalized muscle contractions), 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 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 they do not occur in everyone.
The most commonly reported adverse reactions associated with propafenone hydrochloride treatment are dizziness, conduction disorders, and palpitations.
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Below is a list of adverse reactions reported in clinical trials and following the marketing of propafenone hydrochloride.

Very common (in at least 1 out of 10 patients)

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

Common (in 1 to 10 out of 100 patients)

• 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-glutamyltransferase activity, and increased alkaline phosphatase activity in blood)
• chest pain, asthenia (weakness), feeling of fatigue, fever

Uncommon (in 1 to 10 out of 1,000 patients)

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

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

• agranulocytosis (complete or almost complete absence of granulocytes in blood), leukopenia (reduced number of white blood cells), granulocytopenia (reduced number of granulocytes)
• hypersensitivity (may manifest as cholestasis, abnormal blood composition, 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 related to change in 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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, 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 this medicine.
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5. How to store Rytmonorm 150

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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, corn 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, with the imprint "150" on one side.
Pack sizes: 20, 50 or 90 coated tablets.
Blister packs made of PVC/Al foil in cardboard cartons.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Spain, 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, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Spanish Marketing Authorisation Number (country of export): 986240.4
Parallel Import Licence Number: 412/21
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