ARYTHMOL Film coated tablet Ref.[7342] Active ingredients: Propafenone

Posology

It is recommended that Arythmol therapy should be initiated under hospital conditions, by a physician experienced in the treatment of arrhythmias. The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and blood pressure control. If the QRS interval is prolonged by more than 20%, the dose should be reduced or discontinued until the ECG returns to normal limits.

Adults

Initially, 150 mg three times daily increasing at a minimum of three-day intervals to 300 mg twice daily and if necessary, to a maximum of 300 mg three times daily.

Dose increases should not be attempted until the patient has been receiving treatment for three to four days.

The tablets should be swallowed whole and taken with a drink. A reduction in the total daily dose is recommended for patients below 70 kg bodyweight.

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. Treatment should be initiated gradually and with particular caution in small incremental doses.

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.

Paediatric population

A suitable dosage form of Arythmol for children is not available.

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 plasma level monitoring.

Method of administration

Owing to the bitter taste and surface anesthetic action of propafenone, the film-coated tablets and sugar-coated tablets should be swallowed whole (without chewing) with liquid.

Symptoms of overdosing

Myocardial symptoms

The effects of propafenone overdose in the myocardium manifest as impulse generation and conduction disorders such as PQ prolongation, QRS widening, suppression of sinus node automaticity, AV block, ventricular tachycardia and ventricular fibrillation. Reduction of contractility (negative inotropic effect) can cause hypotension which, in severe cases, can lead to cardiovascular shock.

Non-cardiac symptoms

Headache, dizziness, blurred vision, paraesthesia, tremor, nausea, constipation and dry mouth may occur frequently. In extremely rare cases, convulsions have been reported on overdose. Death has also been reported.

In severe cases of poisoning, clonic-tonic convulsions, paraesthesia, somnolence, coma and respiratory arrest may occur.

Treatment

In addition to general emergency measures, the patient’s vital parameters should be monitored in an intensive care setting, and rectified, as appropriate.

Defibrillation as well as infusion of dopamine and isoproterenol have been effective in controlling rhythm and blood pressure. Convulsions have been alleviated with intravenous diazepam. General supportive measures such as mechanical respiratory assistance and external cardiac massage may be necessary.

Attempts to achieve elimination via haemoperfusion are of limited efficacy.

Owing to high protein binding (>95%) and the large volume of distribution, haemodialysis is ineffective.

3 years.

Do not store above 30°C.

PVC/aluminium blister strips containing 90 tablets.

None.