Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
Profind Wholesale Ltd.
200 Milligram
Tablets
2011-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amiodarone Hydrochloride 200mg. Excipients: Also contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the Netherlands and Hungary:_ Round, white tablet with a scoreline on one side and a logo and ‘200’ engraved on either side of the scoreline. 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 Read the complete document