Rytmonorm 150

Package leaflet: Information for the patient

Warning! Keep the 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 of 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Rytmonorm 150 and what is it 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 is Rytmonorm 150 and what is it used for

Propafenone hydrochloride – the active substance of 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. 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, excluding 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 pacemaker
• Severe hypotension
  • 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 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 drugs, 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 examinations 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 pacemaker, the doctor will check 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 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.
Using 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 reduce heart rate and/or myocardial contractility (β-blockers, tricyclic antidepressants). Increased risk of lidocaine's adverse effects on the central nervous system has been reported when lidocaine was 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 agents, such as cyclosporine
• Medicines used to treat 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 to treat peptic ulcer disease (e.g. cimetidine)
• Antiarrhythmic medicines (e.g. quinidine)
• Antibacterial agents - 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, 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 efficacy:

• 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 the influence of one medicine on the effects of another 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 you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, you should consult your 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.
It is not known whether propafenone passes into human 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 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 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 doubts, consult a
physician or pharmacist.
The physician will determine the dosage individually.
Due to the bitter taste of propafenone and its local anesthetic effect, the coated tablets should be
swallowed whole (without chewing), with a drink.

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, increasing the daily dose of propafenone hydrochloride up to
900 mg may be necessary. 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 may 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 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 disease, treatment should be initiated gradually
and with special caution, starting with low doses that are progressively increased. The same
applies to maintenance therapy. If dose escalation is necessary, it may be performed only after
five to eight days of treatment.

Patients with hepatic and/or renal impairment
In patients with hepatic and/or renal dysfunction, drug accumulation may occur after usual
therapeutic doses. In these patients, the physician will individually adjust the dosage, monitoring
the ECG and plasma drug concentration.

Use of a higher than recommended dose of Rytmonorm 150
In case of overdose, cardiac disturbances, cardiac arrest, hypotension, and in severe cases,
cardiogenic shock may occur.
Other symptoms may 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
generalized muscle contractions), paresthesias (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 physician 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 disturbances, and palpitations.
The adverse reactions listed below have been 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)
• disturbances in cardiac conduction
• palpitations.

Common (in 1 to 10 out of 100 patients)

• anxiety, sleep disturbances
• headache, taste disturbance
• blurred vision
• sinus bradycardia, bradycardia, tachycardia, 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 (in 1 to 10 out of 1,000 patients)

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (impaired coordination), paresthesia (numbness, tingling)
• dizziness
• ventricular tachycardia
• cardiac arrhythmia
• 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 near-complete absence of granulocytes in the blood), leukopenia (reduced white blood cell count), granulocytopenia (reduced granulocyte count)
• hypersensitivity (may manifest as cholestasis, blood abnormalities, and rash)
• confusion
• seizures, extrapyramidal symptoms, motor restlessness
• ventricular fibrillation, heart failure (may worsen 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 possible 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 enables better assessment of the safety profile of the medicine.

5. How to store Rytmonorm 150

Keep this medicine out of sight and reach of children.
No special storage conditions apply.
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 required. Such measures will help protect the environment.

6. Contents of the pack 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: 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.
Packs containing 20, 50 or 90 coated tablets.
PVC/Al blisters in a cardboard box.
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, the country of export: 986240.4
Parallel import authorisation number: 263/21