Rytmonorm: detailed information

Patient Information Leaflet

Rytmonorm 150 mg film-coated tablets, 300 mg film-coated tablets, 325 mg prolonged-release hard capsules, 425 mg prolonged-release hard capsules

propafenone hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Rytmonorm is and what it is used for
What you need to know before taking Rytmonorm
How to take Rytmonorm
Possible side effects
How to store Rytmonorm
Contents of the pack and other information

1. What Rytmonorm is and what it is used for

Rytmonorm contains the active substance propafenone hydrochloride, which belongs to a group of medicines called antiarrhythmic agents. These medicines slow down and help regulate the heartbeat.
Rytmonorm is used to treat and prevent disturbances in heart rhythm (ventricular and supraventricular tachycardias and tachyarrhythmias, including Wolff-Parkinson-White (W.P.W.) syndrome), when associated with disabling symptoms.

2. What you need to know before taking Rytmonorm

Do not take Rytmonorm if:

you are allergic to propafenone hydrochloride or to other similar substances, or to any of the other ingredients of this medicine (listed in section 6);
you are pregnant, unless specifically instructed by your doctor (see "Pregnancy and breastfeeding");
you are breastfeeding (see "Pregnancy and breastfeeding");
your heart is not functioning properly (manifest heart failure or congestive heart failure);
you have had a heart attack within the last three months;
you have a serious circulation problem due to reduced heart activity (cardiogenic shock, except when caused by arrhythmia);
you have Brugada syndrome, or a defect or block in the heart's electrical conduction;
you have a very slow heartbeat (severe symptomatic bradycardia) or very low blood pressure (marked hypotension);
you suffer from other heart problems (severe pre-existing conduction disorders at sinoatrial, atrioventricular, and intraventricular levels; sick sinus syndrome (bradycardia-tachycardia syndrome); atrial conduction defects; second- or higher-degree atrioventricular block; bundle branch block or distal block in the absence of an artificial pacemaker);
you have severe respiratory disorders (severe obstructive lung disease);
you have been diagnosed with a serious muscle disease known as myasthenia gravis;
you have an imbalance in your body's electrolyte levels (e.g. potassium);
you are taking a medicine called ritonavir used to treat AIDS (see section “Other medicines and Rytmonorm”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Rytmonorm.
Before and during treatment with Rytmonorm, your doctor must perform regular check-ups (ECG, clinical examinations) to assess your response to this medicine.
Take this medicine with caution and inform your doctor if:

you have previously had a heart attack. In this case, your doctor will prescribe this medicine only when absolutely necessary (life-threatening ventricular arrhythmias);
you have liver or kidney problems (impaired hepatic or renal function). In such cases, your doctor must reduce the dose and monitor you regularly with an electrocardiogram (see section “Use in patients with liver or kidney problems”);
you have respiratory tract problems (obstructive bronchopulmonary disease, asthma);
you have a serious heart condition (significant structural heart disease), as you may be more susceptible to adverse effects of this medicine. During treatment with Rytmonorm, the following conditions may occur (also see section “Possible side effects”):
worsening of symptoms of a muscle disease called myasthenia gravis or worsening of your heart problems (conversion of paroxysmal atrial fibrillation into atrial flutter with resulting 2:1 or 1:1 conduction block);
changes in the function of your pacemaker. In this case, your doctor must carefully monitor and adjust the device settings;
Brugada syndrome (a defect or block in the heart's electrical conduction) or ECG (electrocardiogram) changes resembling Brugada syndrome in previously asymptomatic carriers. In such cases, your doctor must monitor you regularly with an electrocardiogram. If Brugada syndrome develops, treatment with propafenone must be discontinued;
agranulocytosis (reduction in white blood cell count), increasing the risk of infections; if you develop fever or other signs of infection, contact your doctor immediately. In such cases, treatment should be suspended.

If you are scheduled for surgery (including dental procedures), it is important to inform the surgeon or dentist that you are taking Rytmonorm, as this medicine may interact with anaesthetics (such as lidocaine) or other treatments used (see "Other medicines and Rytmonorm").

Other medicines and Rytmonorm
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:

local anaesthetics, medicines used to induce anaesthesia during surgery (e.g. lidocaine);
beta-blockers, medicines used to treat high blood pressure or heart conditions (e.g. propranolol, metoprolol);
tricyclic antidepressants, medicines used to treat depression (e.g. desipramine), or other antidepressants (venlafaxine, fluoxetine, paroxetine);
medicines affecting heart activity, such as amiodarone, digoxin, quinidine;
anticoagulants, medicines used to prevent blood clots (e.g. warfarin, fenprocoumon);
antibiotics (e.g. erythromycin or rifampicin);
cimetidine, a medicine used to treat ulcers;
cyclosporine, an immunosuppressant used after organ transplantation or to treat arthritis or psoriasis;
theophylline, a medicine used to treat asthma;
ketoconazole, a medicine used to treat fungal infections;
phenobarbital, a medicine used to treat epilepsy;
ritonavir, a medicine used to treat HIV infection.

Rytmonorm and beverages
Avoid taking Rytmonorm with grapefruit juice, as this may interact with your treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, this medicine should be used only under strict medical supervision.
Do not take Rytmonorm if you are pregnant (see section “Do not take Rytmonorm”) unless otherwise directed by your doctor.
Do not take Rytmonorm if you are breastfeeding.

Driving and using machines
Rytmonorm may affect your ability to drive or operate machinery. During treatment, blurred vision, dizziness, fatigue, and low blood pressure may occur. If you experience these symptoms, avoid driving, operating machinery, or performing any activity requiring alertness.

Rytmonorm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet/capsule, i.e., essentially "sodium-free".

3. How to take Rytmonorm

Take Rytmonorm exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Adults
Rytmonorm coated tablets
The recommended daily dose is 450–600 mg, i.e. 1 tablet of Rytmonorm 150 mg three times a day or 1 tablet of Rytmonorm 300 mg twice a day.
After 3–4 days of treatment, your doctor may assess whether it is necessary to increase the dose up to the maximum recommended dose of 900 mg, i.e. 2 tablets of Rytmonorm 150 mg three times a day or 1 tablet of Rytmonorm 300 mg coated tablets three times a day.
Rytmonorm prolonged-release hard capsules
The recommended daily dose is 650 mg, i.e. 1 capsule of Rytmonorm 325 mg twice a day.
After 5 days of treatment, your doctor may assess whether it is necessary to increase the dose, advising you to take 1 capsule of Rytmonorm 425 mg twice a day.
Use in elderly patients and patients with severe heart problems
If you are elderly or have severe heart damage, the dose of Rytmonorm must be increased gradually, and your doctor must monitor you closely, especially at the beginning of treatment.
Use in patients with liver or kidney problems
If you have liver or kidney problems (hepatic/renal insufficiency), your doctor must monitor you closely and reduce the dose of this medicine.
Use in children and adolescents
The safety and efficacy of Rytmonorm prolonged-release hard capsules have not yet been established.
Method of administration
This medicine is taken orally.
Rytmonorm coated tablets: swallow the tablets whole with a glass of water, without chewing.
Rytmonorm prolonged-release hard capsules: swallow the capsules whole with a glass of water, without chewing; do not crush or divide the capsule contents.
If you take more Rytmonorm than you should
Contact your doctor IMMEDIATELY or go to the nearest hospital.
High doses of this medicine may cause: changes in heart rhythm or electrocardiogram (ECG), lowering of blood pressure (sometimes sudden), headache, dizziness, blurred vision, sensory disturbances (paraesthesia), tremors, nausea, difficulty evacuating (constipation), dry mouth, seizures, drowsiness, and in severe cases, respiratory arrest, coma, and even death.
If you forget to take Rytmonorm
Do not take a double dose to make up for the missed dose.
If you stop taking Rytmonorm
It is important that you continue taking this medicine for the entire duration prescribed by your doctor. DO NOT STOP TREATMENT just because you feel better, as your symptoms may return or worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Rytmonorm immediately and contact your doctor if you experience any of the following:

allergic reactions manifesting as itching, sudden or gradual appearance of skin lesions, for example discoloured spots or widespread rash, swelling of the face, eyes, lips, tongue or throat, breathing difficulties, blood abnormalities, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
weight loss, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of allergy, liver damage, cholestasis or inflammation of the liver (hepatitis).

Very common side effects (may affect more than 1 in 10 people)

dizziness;
sensation of palpitations, disturbances in heart conduction.

Common side effects (may affect up to 1 in 10 people)

changes in heart rate such as slowing (sinus bradycardia, bradycardia) or increase (tachycardia) or marked increase (flutter);
anxiety, sleep disturbances, headache, taste disturbances;
blurred vision;
chest pain, difficulty breathing;
abdominal pain, vomiting, nausea, diarrhoea, difficulty passing stools (constipation), dry mouth;
abnormal liver function tests (e.g. increased transaminases, gamma-glutamyl transferase, alkaline phosphatase in blood);
feeling of malaise (asthenia), fatigue, fever.

Uncommon side effects (may affect up to 1 in 100 people)

decrease in blood platelets (thrombocytopenia);
loss of appetite;
nightmares, vertigo, fainting (syncope), coordination problems (ataxia), disturbances in sensation (paraesthesiae);
increased heart rate (ventricular tachycardia);
disturbances in heart rhythm (arrhythmia), low blood pressure (hypotension);
skin eruptions such as urticaria, redness (erythema), itching;
abdominal distension, presence of gas in the intestine (flatulence);
erectile dysfunction.

Other side effects with unknown frequency

ventricular fibrillation (a type of heart rhythm disturbance), reduced heart function or rate, changes in electrocardiogram (prolonged QRS complex on electrocardiogram), abnormal cardiac conduction (first-degree atrioventricular block, increased pacing threshold);
reduced levels of white blood cells (leucopenia) or of certain types of white blood cells (agranulocytosis, granulocytopenia) in blood, with increased risk of infections;
sudden drop in blood pressure upon rapidly changing from a lying or sitting position to standing (orthostatic hypotension);
confusion, seizures, absence or reduced movement with muscle rigidity (extrapyramidal disorder), restlessness, amnesia (loss of memory);
nausea, stomach or intestinal disturbances;
lupus-like syndrome manifesting as facial rash, joint pain, muscle problems and fever, subacute cutaneous lupus erythematosus, syndrome manifesting with skin erythemas;
reduced sperm count (which resolves after discontinuation of treatment);
narrowing of the lumen of a main bronchus (bronchostenosis); pathological enlargement of the liver (hepatomegaly).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rytmonorm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Rytmonorm coated tablets
This medicine does not require any special storage conditions.
Rytmonorm prolonged-release hard capsules
Store the medicine at a temperature below 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rytmonorm contains
The active substance is: propafenone hydrochloride.
Rytmonorm coated tablets
One 150 mg or 300 mg coated tablet contains: 150 mg or 300 mg of propafenone hydrochloride.
The other components are: pregelatinized starch, copovidone, crospovidone, hypromellose, macrogol 6000,
magnesium stearate, sodium lauryl sulfate, talc, titanium dioxide.
Rytmonorm prolonged-release hard capsules
One 325 mg or 425 mg prolonged-release hard capsule contains: 325 mg or 425 mg of propafenone
hydrochloride.
The other components are: hypromellose, magnesium stearate, gelatin, red iron oxide (E 172), sodium
lauryl sulfate, titanium dioxide (E 171).
Description of the appearance of Rytmonorm and contents of the pack
Rytmonorm coated tablets are available in packs containing 30 or 60 coated tablets.
Rytmonorm prolonged-release hard capsules are available in packs containing 28 capsules.
Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
Rytmonorm coated tablets
ITC Farma S.r.l., Via Pontina km 29, 00071 Pomezia (Rome)
Rytmonorm prolonged-release hard capsules
ITC Farma S.r.l., Via Pontina km 29, 00071 Pomezia (Rome)
Famar A.V.E. Anthoussa Plant - Anthoussa Avenue 7, 15344 Anthoussa Attiki – Greece

Package leaflet: information for the patient

Rytmonorm 70 mg/20 ml concentrate solution for intravenous infusion

propafenone hydrochloride
Please read this leaflet carefully before using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Rytmonorm is and what it is used for
What you need to know before using Rytmonorm
How to use Rytmonorm
Possible side effects
How to store Rytmonorm
Contents of the pack and other information

1. What Rytmonorm is and what it is used for

Rytmonorm contains the active substance propafenone hydrochloride, which belongs to a group of medicines called antiarrhythmic agents. These medicines slow down and help regulate the heartbeat.
Rytmonorm is used for the rapid treatment and prevention of disturbances in heart rhythm (ventricular and supraventricular tachycardias and tachyarrhythmias, including Wolff-Parkinson-White (W.P.W.) syndrome), when associated with disabling symptoms.

2. What you should know before using Rytmonorm

Do not use Rytmonorm if:

you are allergic to propafenone hydrochloride or to other similar substances or to any of the other ingredients of this medicine (listed in section 6);
you are pregnant, unless specifically instructed by your doctor (see "Pregnancy and breastfeeding");
you are breastfeeding (see "Pregnancy and breastfeeding");
your heart is not functioning properly (heart failure or congestive cardiac failure);
you have had a heart attack within the last three months;
you have a serious circulation problem due to reduced heart activity (cardiogenic shock, except when caused by arrhythmia);
you have Brugada Syndrome, or a defect or block in the heart's electrical conduction;
you have a severely slow heartbeat (severe symptomatic bradycardia) or very low blood pressure (marked hypotension);
you suffer from other heart problems (serious pre-existing conduction disorders at sinoatrial, atrioventricular, or intraventricular levels; sick sinus syndrome (bradycardia-tachycardia syndrome); atrial conduction defects; second- or higher-degree atrioventricular block; bundle branch block or distal block in the absence of an artificial pacemaker);
you have severe respiratory problems (severe obstructive lung disease), or have been diagnosed with the serious muscle disorder known as myasthenia gravis;
you have an imbalance in body electrolyte levels (e.g. potassium);
you are taking a medicine called ritonavir used to treat AIDS (see section "Other medicines and Rytmonorm").

Warnings and precautions
Talk to your doctor or pharmacist before taking Rytmonorm.
Before and during treatment with Rytmonorm, your doctor must perform periodic checks (ECG, clinical examinations) to assess your response to this medicine.
Take this medicine with caution and inform your doctor if:

you have previously had a heart attack. In this case, your doctor will prescribe this medicine only when absolutely necessary (life-threatening ventricular arrhythmias);
you have liver or kidney problems (impaired hepatic or renal function). In such cases, your doctor must reduce the dose and monitor you regularly with electrocardiograms (see section “Use in patients with liver or kidney problems”);
you have respiratory problems (obstructive bronchopulmonary disease, asthma);
you have a serious heart condition (significant structural heart disease), as you may be more susceptible to adverse effects of this medicine. During treatment with Rytmonorm, the following conditions may occur (also see section “Possible side effects”):
worsening of symptoms of the muscle disorder myasthenia gravis or of your heart problems (conversion of paroxysmal atrial fibrillation into atrial flutter with resulting 2:1 or 1:1 conduction block);
disturbances in the functioning of your pacemaker. In such cases, your doctor must carefully monitor and adjust the device settings;
Brugada Syndrome (a defect or block in the heart's electrical conduction) or ECG changes resembling Brugada Syndrome in previously asymptomatic carriers. In these cases, your doctor must monitor you regularly with electrocardiograms. If Brugada Syndrome develops, treatment with propafenone must be discontinued;
agranulocytosis (reduction in white blood cell count), increasing the risk of infections; contact your doctor if you develop fever or other signs of infection. In such cases, treatment should be suspended.

If you are scheduled for surgery (including dental procedures), it is important to inform the surgeon or dentist that you are taking Rytmonorm, as this medicine may affect anaesthetics (such as lidocaine) or other treatments used (see "Other medicines and Rytmonorm").

Other medicines and Rytmonorm
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:

local anaesthetics, medicines used to induce anaesthesia during surgery (e.g. lidocaine);
beta-blockers, medicines used to treat high blood pressure or heart problems (e.g. propranolol, metoprolol);
tricyclic antidepressants, medicines used to treat depression (e.g. desipramine), or other antidepressants (venlafaxine, fluoxetine, and paroxetine);
medicines that affect heart activity, such as amiodarone, digoxin, quinidine;
anticoagulants, medicines used to prevent blood clots (e.g. warfarin, phenprocoumon);
antibiotics (e.g. erythromycin or rifampicin);
cimetidine, a medicine used to treat ulcers;
cyclosporine, an immunosuppressant used after organ transplantation or to treat arthritis or psoriasis;
theophylline, a medicine used to treat asthma;
ketoconazole, a medicine used to treat fungal infections;
phenobarbital, a medicine used to treat epilepsy;
ritonavir, a medicine used to treat HIV.

Rytmonorm and beverages
Avoid taking Rytmonorm with grapefruit juice, as this may interact with the treatment.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, this medicine should be used only under strict medical supervision.
Do not take Rytmonorm during pregnancy (see section “Do not take Rytmonorm”) unless otherwise directed by your doctor.
Do not use Rytmonorm if you are breastfeeding.

Driving and using machines
Rytmonorm may impair your ability to drive or operate machinery, as blurred vision, dizziness, fatigue, and low blood pressure may occur during treatment. If you experience these symptoms, avoid driving or operating machinery or performing any activity requiring alertness.

3. How to use Rytmonorm

This medicine will be administered to you exclusively by medical personnel through an injection into a
vein (intravenous route). Your doctor will determine the correct dose based on your body weight.
Adults
The recommended dose of Rytmonorm is 1 mg per kilogram of body weight (approximately 1 vial for a
person weighing 70 kg).
Depending on your condition (for example, liver or kidney problems) and your response to treatment, your
doctor may consider adjusting the above dose, either by reducing or increasing it.
Additional “Information intended exclusively for doctors or healthcare professionals” is available at the
end of this leaflet.
If you use more Rytmonorm than you should
Since Rytmonorm is administered by medical personnel, overdose is unlikely.
High doses of this medicine may cause: changes in heart rhythm or electrocardiogram (ECG), lowering of
blood pressure, sometimes sudden and severe, headache, dizziness, blurred vision, sensory disturbances
(paresthesias), tremors, nausea, difficulty passing stools (constipation), dry mouth, seizures, drowsiness, and
in severe cases, respiratory arrest, coma, and even death.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Rytmonorm immediately and contact your doctor if you experience any of the following:

allergic reactions manifesting as itching, more or less sudden appearance of skin lesions, for example discoloured spots or widespread rash, swelling of the face, eyes, lips, tongue or throat, breathing difficulties, blood disorders, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
weight loss, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of allergy, liver damage, cholestasis or liver inflammation (hepatitis).

Very common side effects (may affect more than 1 in 10 people)

dizziness;
sensation of heart pounding, disturbances in heart conduction.

Common side effects (may affect up to 1 in 10 people)

changes in heart rate such as slowing (sinus bradycardia, bradycardia) or increase (tachycardia) or marked increase (flutter);
anxiety, sleep disturbances, headache, altered taste;
blurred vision;
chest pain, difficulty breathing;
abdominal pain, vomiting, nausea, diarrhoea, difficulty passing stools (constipation), dry mouth;
abnormal liver function tests (e.g. increased transaminases, gamma-glutamyltransferase, alkaline phosphatase in blood);
feeling unwell (asthenia), fatigue, fever.

Uncommon side effects (may affect up to 1 in 100 people)

decreased platelet count in blood (thrombocytopenia);
decreased appetite;
nightmares, dizziness, fainting (syncope), coordination problems (ataxia), altered sensation (paraesthesiae);
increased heart rate (ventricular tachycardia);
disturbances in heart rhythm (arrhythmia), low blood pressure (hypotension);
skin rashes such as urticaria, redness (erythema), itching;
abdominal distension, presence of gas in the intestine (flatulence);
erectile dysfunction.

Other side effects with unknown frequency

ventricular fibrillation (a type of heart rhythm disturbance), reduced heart function or heart rate, changes in electrocardiogram (prolonged QRS complex on electrocardiogram), abnormal cardiac conduction (first-degree atrioventricular block, increased pacing threshold);
reduced levels of white blood cells (leucopenia) or of certain types of white blood cells (agranulocytosis, granulocytopenia) in blood, increasing the risk of infections;
sudden drop in blood pressure upon rapidly changing from a lying or sitting position to standing (orthostatic hypotension);
confusion, seizures, reduced or absent movement with muscle rigidity (extrapyramidal disorder), restlessness, amnesia (loss of memory);
nausea, stomach or intestinal disturbances;
lupus-like syndrome manifesting as facial rash, joint pain, muscle problems and fever, subacute cutaneous lupus erythematosus, syndrome presenting with skin erythemas;
reduced sperm count (which resolves after discontinuation of treatment);
narrowing of the lumen of a main bronchus (bronchostenosis);
pathological enlargement of the liver (hepatomegaly).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rytmonorm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store the medicine at a temperature between 15°C and 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rytmonorm contains
The active substance is: propafenone hydrochloride.
One 20 ml vial contains: 70 mg of propafenone hydrochloride.
The other components are: water for injections, glucose.
Description of the appearance of Rytmonorm and package contents
This medicinal product is available in packages containing 5 vials of 20 ml each.
Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Famar Health Care Services Madrid S.A.U. – Madrid (Spain)

Information intended exclusively for physicians or healthcare professionals. For further details,
please refer to the Summary of Product Characteristics.
Rytmonorm 70 mg/20 ml solution for injection for intravenous use
Dosage
Dosage must be individualized and determined under ECG monitoring and blood pressure surveillance. When administering infusion solutions, careful monitoring of the ECG (QRS, PR, and QTc intervals) and circulatory parameters is required.
Low doses of propafenone may be sufficient to achieve the desired therapeutic response.
The single intravenous dose is 1 mg/kg body weight (corresponding to one 20 ml vial in patients weighing 70 kg).
Often, the desired therapeutic effect can already be achieved with a dose of 0.5 mg/kg body weight (corresponding to 10 ml of solution). If necessary, the single dose may be increased to 2 mg/kg body weight (corresponding to 40 ml of solution).
Treatment should be initiated with the lowest possible dose, with the patient under close observation and strict electrocardiographic and blood pressure monitoring.
Method of administration
Slow intravenous injection must be administered over a period of 3–5 minutes.
The interval between two injections must not be less than 90–120 minutes. If the QRS interval is prolonged or if a QTc interval prolongation exceeding 20% of the corrected QT interval is observed, administration must be stopped immediately.
Short-term infusion
For short-term infusion (1–3 hours), the infusion rate is 0.5–1 mg/min of Rytmonorm 70 mg/20 ml solution for injection.
Slow intravenous infusion
For slow intravenous infusion, the maximum daily dose is generally 560 mg (corresponding to 160 ml of solution). For the preparation of the infusion, a 5% glucose or fructose solution must be used. Due to the risk of precipitation, physiological saline solution is not suitable for preparing the infusion solution.
Special populations
Renal impairment
Propafenone hydrochloride should be administered with caution in patients with renal impairment.
Hepatic impairment
Dosage must be adjusted in patients with hepatic impairment.