RYTMONORM TABLET 150 MG [SIN00395P]

Product Info

RYTMONORM TABLET 150 MG

[SIN00395P]

4.1. Therapeutic indications
Symptomatic supraventricular tachyarrhythmias warranting treatment, such as AV junctional tachycardias, supraventricular tachycardias in patients with WPW syndrome or paroxysmal atrial fibrillation. Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment in the judgement of the physician.

4.2. Posology and method of administration
The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (stabilization phase) unless otherwise prescribed by the physician.

For initial and maintenance treatment a daily dose of 450–600 mg divided in two or three doses per day (one 150 mg Rytmonorm coated tablet three times daily) is recommended. Occasionally an increase of the daily dose to 900 mg may be necessary (two 150 mg Rytmonorm coated tablets three times daily).

These data apply to patients with a body weight of about 70 kg. The daily doses should be reduced accordingly for patients with a lower body weight. Dose increases should not be attempted until the patient has been receiving treatment for three to four days.
This daily dose should be exceeded only in exceptional circumstances and under strict cardiological control.

In those patients in whom significant widening of the QRS complex, prolonging of the PR interval or second or third degree AV block occurs, a dose reduction should be considered.

Particularly in the elderly and in patients with marked previous myocardial damage (relevant impairment of left ventricular function or structural myocardial disease), the first dose increase should take place after 5 to 8 days of therapy.

When prescribing propafenone, it should be taken into account that there is no evidence that antiarrhythmic treatment with Class 1 antiarrhythmics improves survival.

Elderly population
No overall differences in safety or effectiveness were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out, therefore, these patients should be carefully monitored. The same applies to maintenance therapy. Any dose increases that may be required should not be undertaken until after five to eight days of therapy.

Liver/Renal Impairment
In patients whose liver and/or kidney function is impaired, there may be drug accumulation after standard therapeutic doses. Nonetheless, patients with these conditions can still be titrated on propafenone hydrochloride under ECG and clinical monitoring.
Propafenone hydrochloride should be administered cautiously in patients with renal disease.

The dosage must be adjusted in patients with liver disease.

Method of administration
Because of the bitter taste and the surface anaesthetic action of propafenone, the coated tablets should be swallowed whole together with some liquid.

4.3. Contraindications

• Known hypersensitivity to propafenone hydrochloride or to any of the excipients

• Known Brugada Syndrome (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Incident of myocardial infarction within the last 3 months

• Significant structural heart disease such as:

  • uncontrolled congestive heart failure where left ventricular output is less than 35%

  • cardiogenic shock (unless this is caused by arrhythmia)

  • severe symptomatic bradycardia

  • presence of sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block or bundle branch block or distal block in the absence of an artificial pacemaker

  • severe hypotension

• Manifest electrolyte imbalance (e.g. potassium metabolism disorders)

• Severe obstructive pulmonary disease

• Myasthenia gravis

• Concomitant treatment with ritonavir