Ritmonorm 300

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Rytmonorm 300(Rytmonorm 300 mg)

300 mg, coated tablets

Propafenone hydrochloride
Rytmonorm 300 and Rytmonorm 300 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rytmonorm 300 and what is it used for
• 2. Important information before taking Rytmonorm 300
• 3. How to take Rytmonorm 300
• 4. Possible side effects
• 5. How to store Rytmonorm 300
• 6. Contents of the packaging and other information

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

Propafenone hydrochloride, the active substance of Rytmonorm 300, has anti-arrhythmic properties, meaning it restores or maintains a normal heart rhythm. The mechanism of action of the medicine 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 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,
• for severe symptomatic ventricular tachyarrhythmia, if the doctor considers it life-threatening.

2. Important information before taking Rytmonorm 300

When not to take Rytmonorm 300

• If the patient is allergic to the active substance or 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, uncontrolled congestive heart failure, with left ventricular ejection fraction below 35% cardiogenic shock, excluding shock caused by arrhythmia, symptomatic severe bradycardia (bradycardia),

or conduction disorders, sinoatrial node dysfunction, atrioventricular block II° or higher, bundle branch block or distal block in patients without a pacemaker, or severe hypotension;

• If the patient has 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 the patient is taking ritonavir (a medicine used to treat HIV infections) at the same time.

Warnings and precautions

Before starting to take Rytmonorm 300, you should discuss it with your doctor. Propafenone, like other anti-arrhythmic medicines, may cause pro-arrhythmic effects, i.e., it may cause new or worsen existing heart rhythm disorders (see section 4). Before starting treatment with Rytmonorm 300 and during treatment, the doctor will order an ECG test and assess the patient's clinical condition to determine whether the response to the medicine justifies its use and to rule out Brugada syndrome (a genetically determined heart disease). Particular caution should be exercised:

• in patients with an implanted pacemaker, the doctor will check the pacemaker's 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 paroxysmal atrial fibrillation to transition to atrial flutter with a 2:1 or 1:1 conduction block.

Rytmonorm 300 and other medicines

You should 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 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 of the heart muscle (beta-adrenergic blockers, tricyclic antidepressants). There have been reports of increased risk of lidocaine side effects on the central nervous system when used with propafenone hydrochloride.

Rytmonorm 300 may increase the effect of the following medicines:

• medicines metabolized by the CYP2D6 isoenzyme, such as venlafaxine,
• beta-adrenergic blockers, such as propranolol, metoprolol,
• antidepressants, such as desipramine,
• immunosuppressants, 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 increase the effect of Rytmonorm 300:

• antifungal medicines (e.g., ketoconazole),
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine),
• anti-arrhythmic medicines (e.g., quinidine),
• antibacterial medicines - antibiotics (e.g., erythromycin),
• antidepressants from the group of selective serotonin reuptake inhibitors, such as paroxetine, fluoxetine.

If these medicines are taken at the same time as Rytmonorm 300, the doctor will monitor the cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride. The following medicines, when taken with Rytmonorm 300, may reduce its effectiveness:

• phenobarbital,
• rifampicin.

In the case of combined treatment with amiodarone and Rytmonorm 300, 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 have been 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 300 with alcohol

Grapefruit juice may cause an increase in the concentration of propafenone hydrochloride in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. Rytmonorm 300 can be used during pregnancy only if the benefits to the mother outweigh the potential risk to the fetus. There have been no studies on the passage of propafenone into breast milk. Limited data indicate that propafenone may pass into breast milk. Caution should be exercised when taking Rytmonorm 300 in breastfeeding women.

Driving and using machines

Certain 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 reaction speed and impair the ability to drive vehicles and operate machinery. If these occur, you should not drive vehicles or operate machinery.

Rytmonorm 300 contains sodium

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

3. How to take Rytmonorm 300

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult a doctor or pharmacist. The doctor will determine the dose of the medicine 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 adjustment period and in maintenance treatment 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. If there is a significant widening of the QRS complex or an atrioventricular block II° or III°, the doctor will consider reducing the dose. The individual maintenance dose should be determined under cardiac control, including ECG monitoring and multiple measurements of blood pressure (dose adjustment phase). Use in children

Rytmonorm 300, 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 introduced gradually, with particular caution, using small, gradually increasing doses. The same applies to maintenance treatment. If an increase in dose is necessary, it can be done only after 5 to 8 days of treatment. Patients with liver and/or kidney disorders

In patients with liver and/or kidney failure, after administration of the usual therapeutic doses, the medicine may accumulate. In these patients, the doctor will individually adjust the dosage of the medicine, monitoring the ECG and the concentration of the medicine in the blood.

Using a higher dose of Rytmonorm 300 than recommended

In case of overdose, heart rhythm disorders, 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, prickling) of the hands or feet, tremors, 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 muscle contraction of the whole body), paresthesia (tingling), drowsiness, coma, and respiratory arrest. In case of overdose, you should immediately go to the nearest hospital.

Missing a dose of Rytmonorm 300

You should not take a double dose to make up for a missed dose of the medicine. If you have any further doubts about taking this medicine, you should consult a 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 disorders, and palpitations. The following side effects have been reported in clinical trials and after the introduction of propafenone hydrochloride to the market. Very common(in at least 1 in 10 patients)

• dizziness (excluding peripheral dizziness)
• conduction disorders in the heart
• palpitations

Common(in 1 to 10 patients out of 100 patients)

• anxiety, sleep disorders
• 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(in 1 to 10 patients out of 1,000 patients)

• thrombocytopenia (low platelet count)
• decreased appetite, nightmares
• fainting, ataxia (coordination disorders), paresthesia (tingling)
• dizziness
• ventricular tachycardia
• heart rhythm disorders
• hypotension
• increased abdominal circumference, bloating with gas
• hives, 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 (decrease in the number of white blood cells), granulocytopenia (decrease in the number of granulocytes),
• 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 reflex, gastrointestinal disorder
• liver cell damage, cholestasis, hepatitis, jaundice
• lupus-like syndrome
• pustular skin eruptions
• decreased sperm count (reversible after stopping propafenone)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Rytmonorm 300

The medicine should be stored out of sight and reach of children. There are no special storage instructions. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rytmonorm 300 contains

• The active substance of the medicine is propafenone hydrochloride. One coated tablet contains 300 mg of the active substance.
• The other ingredients are: microcrystalline cellulose, sodium carmellose, corn starch, hypromellose, magnesium stearate, purified water; coating: macrogol 400, macrogol 6000, hypromellose, titanium dioxide (E 171).

What Rytmonorm 300 looks like and what the packaging contains

Rytmonorm 300 is available in the form of coated tablets. The coated tablet is white, biconvex with the inscription "300" on one side. Packaging available: 20 pieces - 2 blisters of 10 pieces each, 50 pieces - 5 blisters of 10 pieces each. Blisters made of PVC/Al foil in a cardboard box. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Manufacturer:

ITC Farma s.r.l., Via Pontina km 29, 00071 Pomezia (RM), Italy

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź. Marketing authorization number in Spain, the country of export: 986257.2

Parallel import authorization number: 432/22 Date of approval of the leaflet: 13.12.2022

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