Cordarone X 100mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

AMIODARONE HYDROCHLORIDE

Disponible des:

Imbat Limited

Codi ATC:

C01BD; C01BD01

Designació comuna internacional (DCI):

AMIODARONE HYDROCHLORIDE

Dosis:

100 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Antiarrhythmics, class III; amiodarone

Estat d'Autorització:

Authorised

Data d'autorització:

2008-10-03

Informació per a l'usuari

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE
® X 100MG TABLETS
(amiodarone hydrochloride)
Your medicine is available using the above name but will be
referred to as ‘Cordarone X Tablets’ throughout this leaflet.
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.
Before you take Cordarone X Tablets
3.
How to take Cordarone X Tablets
4.
Possible side effects
5.
How to store Cordarone X Tablets
6.
Contents of the pack and other information
1.
WHAT CORDARONE X TABLETS ARE AND WHAT
THEY ARE USED FOR
Cordarone X Tablets 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 cannot 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.
BEFORE YOU TAKE CORDARONE X TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to:

iodine

amiodarone

any of the ot

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amiodarone hydrochloride 100mg.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the United Kingdom_
Product imported as Amiodarone Hydrochloride: Round, white tablets
with a breakline on one side and imprinted ‘S75’
and ‘STERWIN’ on the other.
Product imported as Cordarone X: Round, white tablets with a breakline
on one side and marked ‘100’ and a logo on
the other side.
4 CLINICAL PARTICULARS
As per PA0540/142/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/142/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Povidone
Colloidal anhydrous silica
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Re-boxed cardboard outer containing blister strips. Pack size 28.
Overlabelled outer