Cordarone X 100 mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

AMIODARONE HYDROCHLORIDE

Disponible des:

Lexon (UK) Ltd

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

Data d'autorització:

2018-08-03

Informació per a l'usuari

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:
What Cordarone X Tablets are and what they are used for
Before you take Cordarone X Tablets
How to take Cordarone X Tablets
Possible side effects
How to store Cordarone X Tablets
Further information
WHAT CORDARONE X TABLETS ARE AND WHAT THEY ARE
USED FOR
Cordarone X 100 mg 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
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 other ingredients of Cordarone X Tablets (listed in
Section 6
below)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
*
You have a slower than usual heartbeat (called ‘sinus
br

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg amiodarone hydrochloride.
Excipient(s) with known effect
Each tablet contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the United Kingdom_
Round, white tablet with a break line on one side imprinted 100 on the
other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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 blister 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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Keep the blister in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets in cardboard cartons.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PA