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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X 200 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg amiodarone hydrochloride.
Excipient: 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 breakline, ‘200’ and a logo on one side, plain on the other side.
The breakline is only to facilitate breaking for ease of swallowing and not to be divided 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 only for the treatment of severe rhythm disorders 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
jud
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