Ritmonorm 150

Package Leaflet: Information for the Patient

Rytmonorm 150, 150 mg, Coated Tablets

Propafenone Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell 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, i.e., it restores or maintains a normal heart rhythm. The mechanism of action of the drug is complex and involves, among other things, stabilizing the cell membrane and blocking sodium channels. Propafenone hydrochloride also has a weak beta-adrenergic blocking effect.
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 doctor considers it life-threatening

2. Important information before taking Rytmonorm 150

When not to take Rytmonorm 150

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have:
• Brugada syndrome
• clinically significant structural heart disease, such as:
• myocardial infarction within the last 3 months
• uncontrolled congestive heart failure, with left ventricular ejection fraction below 35%
• cardiogenic shock, except for shock caused by arrhythmia
• symptomatic severe bradycardia (slow heart rate)
• sinus node dysfunction, atrioventricular conduction disturbances, second- or third-degree atrioventricular block, or bundle branch block in patients without a pacemaker
• severe hypotension
• If you have symptoms of water and electrolyte balance disorders (e.g., potassium metabolism disorders).
• In case of severe obstructive pulmonary disease.
• In patients with myasthenia gravis (a disease characterized by muscle weakness).
• If you are taking ritonavir (a medicine used to treat HIV infections) at the same time.

Warnings and precautions

Before starting to take Rytmonorm 150, discuss it with your doctor.
Propafenone, like other antiarrhythmic drugs, may cause proarrhythmic effects, i.e., it may induce new or exacerbate existing heart rhythm disturbances (see section 4).

• 4).

Before starting treatment with Rytmonorm 150 and during treatment, your doctor will order an ECG and assess your clinical condition to determine whether the response to the drug justifies its use and to rule out Brugada syndrome (a genetically determined heart disease).
Particular caution is required:

• in patients with a pacemaker, the doctor will check the pacemaker's function and, if necessary, reprogram it, as the drug may affect the stimulation threshold and sensitivity of the implanted pacemaker
• in patients with clinically significant structural heart disease, the drug is contraindicated
• in patients with asthma

In some patients, the drug may cause paroxysmal atrial fibrillation to transition to atrial flutter with a 2:1 or 1:1 conduction block.

Rytmonorm 150 and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking Rytmonorm 150 with the following medicines may increase the risk of side effects:

• local anesthetics (e.g., during pacemaker implantation, surgery, or dental procedures)
• other medicines that slow the heart rate and/or contractility (beta-adrenergic blockers, tricyclic antidepressants) There have been reports of increased risk of lidocaine's central nervous system side effects when used with propafenone hydrochloride.

Rytmonorm 150 may increase the effect of the following medicines:
drugs metabolized by the CYP2D6 isoenzyme, such as venlafaxine

• beta-adrenergic blockers, such as propranolol, metoprolol
• antidepressants, such as desipramine
• immunosuppressants, such as cyclosporine
• asthma medications, 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 agents (e.g., ketoconazole)
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine)
• antiarrhythmic agents (e.g., quinidine)
• antibacterial agents - antibiotics (e.g., erythromycin)
• antidepressants from the selective serotonin reuptake inhibitor group, such as paroxetine, fluoxetine

If these medicines are taken at the same time as Rytmonorm 150, the doctor will monitor the cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when taken with Rytmonorm 150, may reduce its effectiveness:

• phenobarbital
• rifampicin

In the case of combined treatment with amiodarone and Rytmonorm 150, it may be necessary to adjust the doses of both medicines, taking into account the response to treatment.
Children and adolescents
Studies on the effect of one medicine on the results of another medicine were conducted only 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 the concentration of propafenone hydrochloride in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Rytmonorm 150 can be used during pregnancy only if the benefits to the mother outweigh the potential risk to the fetus.
It has not been studied whether propafenone passes into breast milk. Limited data suggest that propafenone may pass into breast milk. Caution should be exercised when taking Rytmonorm 150 in breastfeeding women.

Driving and using machines

Some side effects, such as blurred vision, dizziness, fatigue, and orthostatic hypotension (a sudden drop in blood pressure caused by a change in position from lying to standing), may affect your reaction speed and impair your ability to drive and use machines. If these occur, do not drive or operate any machinery.

Rytmonorm 150 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Rytmonorm 150

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will determine the dose individually.
Due to the bitter taste of propafenone and its surface anesthetic effect, the coated tablets should be swallowed whole (without chewing), with a liquid.
Adults
During the dose titration period and in maintenance therapy in patients with a body weight of approximately 70 kg, the recommended daily dose of propafenone hydrochloride is 450 to 600 mg, given in two or three divided doses. Sometimes it may be necessary to increase the daily dose of propafenone hydrochloride to 900 mg. In patients with a lower body weight, the doctor will reduce the daily dose accordingly. The dose can be increased only after 3 to 4 days of treatment.
In case of significant QRS complex widening or second- or third-degree atrioventricular block, the doctor will consider reducing the dose.
The individual maintenance dose should be determined under cardiac monitoring, including ECG recording and multiple measurements of arterial blood pressure (dose titration phase).
Use in children
Rytmonorm 150, due to its strength, cannot be used in children.
Elderly patients
In elderly patients or 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, gradually increasing doses. The same applies to maintenance therapy. If a dose increase is necessary, it can be done only after 5 to 8 days of treatment.
Patients with liver and/or kidney impairment
In patients with liver and/or kidney failure, accumulation of the drug may occur after administration of the usual therapeutic doses. In these patients, the doctor will individually select the dosage, monitoring the ECG and serum drug concentration.

Overdose of Rytmonorm 150

In case of overdose, cardiac arrhythmias, cardiac arrest, and hypotension may occur, as well as metabolic acidosis (a condition of acid-base imbalance in the body), headaches, dizziness, blurred vision, sensory disturbances (tingling, numbness, paresthesia) of the hands or feet, tremors, nausea, constipation, dry mouth, and convulsions (seizures).
Death has also been reported.
In severe cases of poisoning, additional symptoms may include tonic-clonic seizures (seizures with loss of consciousness and muscle contractions), paresthesia, drowsiness, coma, and respiratory arrest.
In case of overdose, seek medical attention immediately.

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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects associated with propafenone hydrochloride treatment are dizziness, conduction disturbances, and palpitations.
The following side effects have been reported in clinical trials and after the marketing of propafenone hydrochloride.
Very common(affects at least 1 in 10 people)

• dizziness (except for peripheral dizziness)
• conduction disturbances in the heart
• palpitations

Common(affects 1 to 10 people in 100)

• anxiety, sleep disturbances
• headache, taste disturbance
• blurred vision
• bradycardia (slow heart rate) sinus, bradycardia, tachycardia (fast heart rate), atrial flutter
• shortness of breath
• abdominal pain, vomiting, nausea, diarrhea, 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 the blood)
• chest pain, asthenia (weakness), fatigue, fever

Uncommon(affects 1 to 10 people in 1,000)

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (coordination disorders), paresthesia (tingling, numbness)
• dizziness
• ventricular tachycardia
• arrhythmias
• hypotension
• increased abdominal girth, bloating with gas
• urticaria, itching, rash, flushing
• erectile dysfunction

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

• agranulocytosis (complete or almost complete lack of granulocytes in the blood), leukopenia (decreased white blood cell count), granulocytopenia (decreased granulocyte count).
• hypersensitivity (may manifest as cholestasis, abnormal blood count, and rash)
• confusional state
• seizures, extrapyramidal symptoms, restlessness
• ventricular fibrillation, heart failure (may worsen existing heart failure), decreased heart rate
• orthostatic hypotension (sudden drop in blood pressure, related to a change in position from lying to standing)
• vomiting, gastrointestinal disturbances
• liver cell damage, cholestasis, hepatitis, jaundice
• lupus-like syndrome
• pustular skin eruptions
• decreased sperm count (reversible after discontinuation of propafenone)

Reporting side effects
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging after the words "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help 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, pregelatinized starch, hypromellose, magnesium stearate, purified water.
  The coating contains: macrogol 400, macrogol 6000, hypromellose, titanium dioxide (E171).

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 inscription "150" on one side.
Pack sizes: 20, 50, or 90 coated tablets.
Blister packs of PVC/Aluminum, in a cardboard box .
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information, please contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Tel: 22 546 64 00
Date of last revision of the leaflet:02/2024