Ritmonorm 300

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of 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. Package contents and other information

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

Propafenone hydrochloride, the active substance of Rytmonorm 300, has antiarrhythmic properties, i.e., 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,
• uncompensated congestive heart failure, with a left ventricular ejection fraction below 35%,
• cardiogenic shock, except for shock caused by arrhythmia,
• symptomatic severe bradycardia (bradycardia),
• sinus node dysfunction, atrioventricular conduction disturbances, second- or third-degree atrioventricular block, or bundle branch block in patients without a pacemaker,
• 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 antiarrhythmic medicines, may cause proarrhythmic effects, i.e., it may induce new or exacerbate existing heart rhythm disturbances (see section 4).
Before starting treatment with Rytmonorm 300 and during treatment, the doctor will order an ECG 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 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 (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 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),
• antiarrhythmic medicines (e.g., quinidine),
• 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 300, the doctor will monitor the cardiovascular system and, if necessary, adjust the dose of propafenone hydrochloride.
The following medicines, when used 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 grapefruit juice

Grapefruit juice may increase 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.
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 using Rytmonorm 300 in breastfeeding women.

Driving and operating 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 machines. If they occur, you should not drive vehicles or operate any machines.

Rytmonorm 300 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 300

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your 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 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 blood pressure measurements (dose titration 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 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 function 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 select the dosage of the medicine, monitoring the ECG and the concentration of the medicine in the blood.

Using a higher than recommended dose of Rytmonorm 300

In case of overdose, heart rhythm disturbances, 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, prickling, numbness) 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 contractions throughout the 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 the use of this medicine, you should consult 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.
Below are the side effects reported in clinical trials and after the introduction of propafenone hydrochloride to the market.
Very common(in at least 1 in 10 patients)

• Dizziness (except for peripheral dizziness).
• Conduction disturbances in the heart.
• Palpitations.

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

• Anxiety, sleep disturbances.
• Headache, taste disturbance.
• Blurred vision.
• Bradycardia (slow heart rate) sinus, bradycardia, tachycardia (fast heart rate), atrial flutter.
• Dyspnea.
• 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 (numbness, tingling).
• Dizziness.
• Ventricular tachycardia.
• Heart rhythm disturbances.
• Hypotension.
• Increased abdominal circumference, bloating with gas discharge.
• 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 composition, 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 disturbance.
• Liver cell damage, cholestasis, hepatitis, jaundice.
• Systemic lupus erythematosus-like syndrome.
• Pustular skin eruptions.
• Decreased sperm count (reversible after discontinuation of 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 Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help to 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 recommendations for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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. Package contents 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 croscarmellose, cornstarch, hypromellose, magnesium stearate, purified water. The coating contains: macrogol 400, macrogol 6000, hypromellose, titanium dioxide (E 171).

What Rytmonorm 300 looks like and what the package 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 of 20 or 50 coated tablets.
PVC/Al blisters 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:

FAMAR LYON
Avenue du General De Gaulle
69230 Saint-Genis Laval
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish marketing authorization number, country of export:986257.2

Parallel import authorization number: 46/22 Date of leaflet approval: 20.01.2022

[Information about the trademark]