Cordarone X 200 tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
06-06-2018
Summary of Product characteristics
(SPC)
06-06-2018
Active ingredient:
Amiodarone hydrochloride
Available from:
Zentiva Pharma UK Ltd
ATC code:
C01BD01
INN (International Name):
Amiodarone hydrochloride
Dosage:
200mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02030200; GTIN: 5013417102095
Patient Information leaflet
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25,5mm
25,5mm
25,5mm
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PACKAGE LEAFLET:
INFORMATION FOR THE USER
CORDARONE ® X 100MG AND 200MG
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, 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. 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 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 other ingredients of Cordarone X Tablets
(listed in S
Read the complete document
Summary of Product characteristics
OBJECT 1
CORDARONE X 200MG TABLETS
Summary of Product Characteristics Updated 06-Mar-2017 | Zentiva
1. Name of the medicinal product
Cordarone X 200
2. Qualitative and quantitative composition
Cordarone X 200 contain 200 mg of amiodarone hydrochloride.
For excipients, see 6.1
3. Pharmaceutical form
Tablet.
Round, white tablet with a breakline on one side, imprinted with 200
on the other.
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.
4.2 Posology and method of 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 200 mg, three times a day and may be
continued for 1 week. The dosage
should then be reduced to 200 mg, twice daily for a further week.
_MAINTENANCE_
After the initial period the dosage should be reduced to 200 mg daily,
or less if appropriate. Rarely, the
patient may require a higher maintenance dose. The scored 100 mg
tablet should be used to titrate the
minimum dosage required to maintain control of the arrhythmia. The
maintenance dose should be
regularly reviewed, especially where this exceeds 200 mg daily.
_GENERAL CONSIDERATIONS_
Initial dosing
A high dose is needed in order to achieve adequate tissue levels
rapidly.
Maintenance
Too high a dose during maintenance therapy can cause side effects
which are
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