国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
PROPAFENONE HYDROCHLORIDE
LTT Pharma Limited
PROPAFENONE HYDROCHLORIDE
300 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arythmol 300mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg propafenone hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Product imported from the UK White, biconvex, film-coated tablets and embossed "300" on one face 4 CLINICAL PARTICULARS 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 tablets should be swallowed whole and taken with a drink after food. The dosage should be adjusted to the individual patient’s requirements. In those patients in whom significant widening of the QRS complex or second or third AV block occurs, a dose reduction should be considered. Adults: A daily dose of 450 to 600mg of propafenone hydrochloride, divided in two or three doses per day, is recommended in the titrated period and for maintenance therapy in patients weighing around 70 kilograms. Occasionally, it may be necessary to increase the daily dose to 900 mg of propafenone hydrochloride. The daily dose should be reduced accordingly for patients with a lower body weight. Dose increases should not be attempted until the patient is receiving treatment for three to four days. The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (titration phase). Elderly: In elderly patients or patients with rel 完全なドキュメントを読む