Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
G & A Licensing Limited
200 Milligram
Tablets
2010-02-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amiodarone Hydrochloride 200mg. Excipient: Lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Italy:_ Round, white with a breakline on one side and imprinted 200 on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X is indicated for the treatment of severe rhythm disorders only when not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. Atrial flutter and fibrillation when other drugs cannot be used. All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias, ventricular fibrillation: when other drugs cannot be used. Cordarone is indicated for the prevention of ventricular arrhythmias in high-risk patients following myocardial infarction or in patients with clinical signs of congestive cardiac failure and/or LVEF less than 40% who are receiving appropriate cardiac failure treatment which includes ACE-inhibitors. The minimum effective dose must be used and treatment must be initiated and used only under hospital/specialist supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cordarone X 200 Tablets are for oral administration. _ADULTS_ It is particularly important that the minimum effective dose be used. In all cases the patient’s management must be judged on the individual response and well bein Lire le document complet