Cordarone X 200mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Amiodarone hydrochloride

Verfügbar ab:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-Code:

C01BD; C01BD01

INN (Internationale Bezeichnung):

Amiodarone hydrochloride

Dosierung:

200 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Antiarrhythmics, class III; amiodarone

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1984-11-26

Gebrauchsinformation

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CORDARONE® X 100MG TABLETS
CORDARONE® X 200MG TABLETS
Amiodarone hydrochloride
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again

If you have any further questions, please ask your doctor or
pharmacist

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist
IN THIS LEAFLET:
1.
What Cordarone X Tablets are and what they are used for
2.
What you need to know before you take Cordarone X
3.
How to take Cordarone X Tablets
4.
Possible side effects
5.
How to store Cordarone X Tablets
6.
Further information
1. WHAT CORDARONE X TABLETS ARE AND WHAT THEY ARE USED FOR
Cordarone X 100mg or 200mg Tablets (called Cordarone X Tablets in this
leaflet) contain a medicine
called amiodarone hydrochloride. This belongs to a group of medicines
called anti-arrhythmics.
It works by controlling the uneven beating of your heart (called
‘arrhythmias’). Taking the tablets helps
your heartbeat to return to normal.
Cordarone X Tablets can be used to:
- Treat uneven heartbeats where other medicines either have not worked
or cannot be used
- Treat an illness called Wolff-Parkinson- White Syndrome. This is
where your heart beats unusually
fast
- Treat other types of fast or uneven heartbeats known as ‘atrial
flutter’ or ‘atrial fibrillation’.
Cordarone X Tablets are used only when other medicines can not be used
- Treat fast heartbeats which may happen suddenly and may be uneven.
Cordarone X Tablets are
used only when other medicines cannot be used
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORDARONE X
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to:
- iodine
- amiodarone
- any of th

Fachinformation

Health Products Regulatory Authority
10 June 2022
CRN00CZ71
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amiodarone Hydrochloride 200 mg.
Excipients: Each tablet contains 96mg lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Round, white with a breakline on one side 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 being. The following dosage regimen
is generally effective.
_INITIAL STABILISATION_
Treatment should be started with 200mg, three times a day and may be
continued for 1