Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PROPAFENONE HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
425 Milligram
Prolonged Release Capsules
2006-03-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arythmol SR 425 mg prolonged release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule contains 425 mg, propafenone hydrochloride It contains 5.685µg soya oil per capsule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. White to almost opaque capsule stamped with red Abbott logo and “425” on the cap.and three red stripes on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arythmol SR (sustained/prolonged release) is indicated to prolong the time to recurrence of symptomatic atrial arrhythmias in patients without significant structural heart disease and with a history of symptomatic atrial fibrillation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of Arythmol SR must be individually titrated on the basis of response and tolerance. Titration to the individual maintenance dose should be supervised by a cardiologist (repeated ECG recordings and blood pressure measurements). It is recommended that therapy be initiated with 225 mg propafenone hydrochloride (as prolonged- release capsules) given every twelve hours. The dosage may be increased at a minimum interval of 5 days to 325 mg propafenone hydrochloride (as prolonged-release capsules) given every twelve hours. If additional therapeutic effect is needed, the dose of propafenone hydrochloride (as prolonged-release capsules) may be increased to 425 mg given every twelve hours after a minimum of another 5 day interval. To facilitate dose titration, additional strengths of propafenone SR are available. Direct comparison of propafenone SR capsules with propafenone IR (immediate/instant release) tablets has not been studied in clinical trials. In those patients i Read the complete document