CORDARONE X 200 MG TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
AMIODARONE HYDROCHLORIDE
Available from:
PCO Manufacturing
Dosage:
200 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2004-03-05
Summary of Product characteristics
License
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 patie
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