Cordarone X 200 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

PCO Manufacturing Ltd.

ATC code:

C01BD; C01BD01

INN (International Name):

AMIODARONE HYDROCHLORIDE

Dosage:

200 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiarrhythmics, class III; amiodarone

Authorization status:

Authorised

Authorization date:

2004-03-05

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE X
® 100 MG TABLETS
CORDARONE X
® 200 MG TABLETS
amiodarone hydrochloride
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 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 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 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.
WHAT YOU NEED TO KNOW 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

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2019
CRN00975F
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X 200 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amiodarone hydrochloride 200 mg.
Excipient: Each tablet contains Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from theNetherlands, Czech Republic, and Hungary:_
Round, white tablet with a breakline, '200' and a logo on one side,
plain on the other side.
_Product imported from the UK:_
Round, white tablet with a breakline on one side, '200' and a logo 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
As per PA0540/142/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/142/002
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 of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
17 November 2019
CRN00975F
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisterpacks of 30 in a carton and 28 or 60 tablets in an overlabelled
outer carton.
Not all pack sizes may bemarketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/119/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 05 March