Rytmonorm 3.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rytmonorm 3.5 mg/ml solution for injection

Propafenone hydrochloride

Read all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Rytmonorm is and what it is used for
2. What you need to know before you use Rytmonorm
3. How to use Rytmonorm
4. Possible side effects
5. How to store Rytmonorm
6. Contents of the pack and other information

1. What Rytmonorm is and what it is used for

Rytmonorm is a medicine used to treat cardiac rhythm disorders of various origins. It belongs to a group of medicines known as class 1C antiarrhythmics according to the Vaughan Williams classification.

Rytmonorm is used for the treatment and prevention of paroxysmal supraventricular tachycardia, including paroxysmal atrial fibrillation and flutter, and paroxysmal tachycardia due to re-entry phenomena affecting the atrioventricular node or accessory pathways (Wolff-Parkinson-White Syndrome). It is also used for the treatment and prevention of ventricular arrhythmias, including symptomatic ventricular extrasystoles and/or non-sustained and sustained ventricular tachycardia.

2. What you need to know before using Rytmonorm

Do not use Rytmonorm

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

• If you have a history of Brugada syndrome (a hereditary condition characterized by an abnormality in the electrocardiogram (ECG) and an increased risk of sudden death) (see Warnings and precautions).

• If you have had a myocardial infarction within the previous 3 months before starting treatment.

• If you have or have had significant heart disease such as:

  • congestive heart failure.
  • cardiogenic shock unless caused by an arrhythmia.
  • severely reduced heart rate (bradycardia).
  • sinus node dysfunction, atrial conduction defects, second-degree or higher atrioventricular block, or bundle branch block or distal block in the absence of a pacemaker.

• If you have severely low blood pressure.

  • If you have an electrolyte imbalance in the blood (e.g., disturbances in potassium metabolism).
  • If you have severe obstructive pulmonary disease.
  • If you have myasthenia gravis.
  • If you are taking ritonavir (an antiretroviral used in the treatment of HIV infection, see Use of Rytmonorm with other medicines).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Rytmonorm.

• It is essential that each patient receiving propafenone be clinically and electrocardiographically evaluated before and during treatment with Rytmonorm to determine whether the response to propafenone justifies continued therapy.

• After treatment with this medicine, your doctor must rule out Brugada syndrome, which may have been present without prior symptoms.

• If you have a pacemaker, because treatment may affect it and therefore it must be monitored and, if necessary, reprogrammed.

• If you have atrial fibrillation, because Rytmonorm may lead to the development of a more serious arrhythmia; see Possible side effects.

• If you have severe heart disease, because you may be predisposed to serious adverse reactions, in which case treatment with this medicine is contraindicated.

• If you have asthma or another chronic obstructive respiratory disease.

Children

Interaction studies have only been conducted in adults, so it is unknown whether these interactions are similar in children.

Elderly patients

Rytmonorm must be used with extreme caution in elderly patients.

Use of Rytmonorm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

More adverse effects may occur with Rytmonorm when administered together with local anesthetics (e.g., for pacemaker implantation, surgical or dental procedures), as well as with other drugs that have an inhibitory effect on the heart such as beta-blockers (for hypertension) or certain antidepressants.

Inform your doctor if you are taking any of the following medicines, as they may increase their blood levels:

• venlafaxine (for depression)
• propranolol (for hypertension and angina pectoris)
• metoprolol (for hypertension)
• desipramine (for depression)
• cyclosporine (to suppress the immune system)
• theophylline (for asthma)
• digoxin (for heart problems)

If signs of overdose occur, the doses of these medicines should be reduced as appropriate.

Inform your doctor if you are taking any of the following medicines, as they may increase your blood levels of propafenone hydrochloride, so monitoring and dose adjustment may be required:

• ketoconazole (for fungal infections)
• cimetidine (for stomach ulcers)
• quinidine (for heart arrhythmia or malaria)
• erythromycin (antibiotic)
• fluoxetine (for depression)
• paroxetine (for depression)

An increase in propafenone hydrochloride levels also occurs with grapefruit juice.

Concomitant use of Rytmonorm and amiodarone may cause heart disturbances. Dose adjustment of both medicines may be necessary.

Concomitant use of propafenone and lidocaine increases the risk of lidocaine-related side effects on the central nervous system.

Inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of Rytmonorm:

• rifampicin (antibiotic)
• phenobarbital (sedative and antiepileptic)
• phenytoin (antiepileptic)
• carbamazepine

In cases of chronic treatment with phenobarbital and/or rifampicin and Rytmonorm, the response to Rytmonorm treatment should be monitored.

Inform your doctor if you are taking medicines to prevent blood clotting (e.g., acenocoumarol or warfarin), because Rytmonorm may enhance the effect of these medicines, increasing the risk of bleeding. If signs of overdose occur, the doses of these medicines should be appropriately reduced.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no adequate and well-controlled studies in pregnant women. Rytmonorm should not be used during pregnancy unless the expected benefit justifies the potential risk to the fetus. Propafenone hydrochloride crosses the placental barrier.

Excretion of propafenone hydrochloride in breast milk has not been studied. Limited data suggest that propafenone hydrochloride may pass into breast milk; therefore, it should be used with caution in breastfeeding mothers.

Driving and use of machines

During treatment, blurred vision, dizziness, fatigue, or low blood pressure may occur. If you experience any of these symptoms, you should not drive or operate dangerous machinery.

3. How to use Rytmonorm

Rytmonorm injection is administered intravenously.

Always follow exactly the administration instructions for this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Your doctor will decide which dose of Rytmonorm is most appropriate for you.

Adults:

Treatment must be individually adjusted and monitored by electrocardiogram and blood pressure measurements.

A single dose of 1 mg/kg body weight is usually administered, although the desired effect is often achieved with doses of 0.5 mg/kg. If necessary, the single dose may be increased to 2 mg/kg body weight. However, your doctor will determine the most appropriate dose of Rytmonorm for you.

Treatment should be initiated with the lowest possible dose while maintaining careful patient observation and close monitoring of the ECG and blood pressure.

Intravenous injections must be administered slowly over a period of 3 to 5 minutes, and the interval between injections should not be less than 90 to 120 minutes. If a prolongation of the QRS interval or of the heart rate-corrected QT interval by more than 20% is observed, the injection must be stopped immediately.

Short-term infusion

When Rytmonorm is administered as a short-term infusion lasting one to three hours, the dosage rate is 0.5 to 1 mg/minute.

Slow intravenous infusion

When Rytmonorm is administered by slow intravenous infusion, a maximum daily dose of 560 mg is generally sufficient. Glucose or fructose (5%) should be used to prepare the solution. Physiological sodium chloride solution must not be used due to the risk of precipitation.

Patients with hepatic impairment

Dose adjustment is not recommended in patients with moderate hepatic impairment. These patients should start with the lowest recommended dose and be carefully monitored. Patients with severe hepatic impairment should start with half or less of the recommended dose for patients with normal liver function. These patients must be carefully monitored, and dose adjustments should be based on clinical symptoms.

Patients with renal impairment

Dose adjustment is not required for intravenous dosing in patients with renal impairment, although propafenone should be administered with caution in these patients.

Elderly patients

Rytmonorm should be administered with caution, paying special attention to clinical and electrocardiographic signs of toxicity.

Use in children

There is no experience with use in children.

If you think that the effect of Rytmonorm is too strong or too weak, inform your doctor or pharmacist.

If you use more Rytmonorm than you should

If you receive more Rytmonorm than you should, you may experience effects on the heart and a drop in blood pressure, which in severe cases may lead to cardiovascular shock. Headache, dizziness, blurred vision, tingling or numbness of the skin, tremor, nausea, constipation, and dry mouth are often observed.

In severe intoxications, seizures, tingling or numbness of the skin, somnolence, coma, and respiratory arrest may occur. Fatal cases have been reported.

If this occurs, the patient must be monitored in an intensive care unit.

If you have used more Rytmonorm than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are classified as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), and frequency not known (cannot be estimated from available data).

Very common adverse reactions associated with propafenone treatment are dizziness, cardiac conduction disorders (heart disturbances), and palpitations.

Within each category, adverse reactions are listed in decreasing order of severity, from most severe to least severe, when the severity for the patient could be determined.

The following adverse effects have been reported:

Blood and lymphatic system disorders

• Uncommon: decrease in platelets (blood cells involved in clotting).

• Frequency not known: decrease in white blood cells (blood cells that defend the body against infections or foreign substances; may present as frequent infections with fever, chills, or sore throat), decrease in granulocytes (a type of white blood cell that may increase susceptibility to infections), severe reduction in granulocytes or neutrophils (agranulocytosis, a condition in which the person is more prone to infections).

Immune system disorders

• Frequency not known: hypersensitivity¹.

¹ May manifest as cholestasis (arrested flow of bile into the duodenum), blood abnormalities, and skin rash.

Metabolism and nutrition disorders

• Uncommon: decreased appetite.

Psychiatric disorders

• Common: anxiety, sleep disturbances.

• Uncommon: nightmares.

• Frequency not known: confusion.

Nervous system disorders

• Very common: dizziness².

• Common: headache, altered taste perception.

• Uncommon: brief loss of consciousness (syncope), abnormal coordination, tingling, numbness, or pins-and-needles sensation anywhere in the body, but most commonly in feet, hands, arms, or legs (paresthesia).

• Frequency not known: seizures, extrapyramidal symptoms (involuntary movements), restlessness.² Excluding vertigo.