Amiodarone 100mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Amiodarone hydrochloride

Beschikbaar vanaf:

Mawdsley-Brooks & Company Ltd

ATC-code:

C01BD01

INN (Algemene Internationale Benaming):

Amiodarone hydrochloride

Dosering:

100mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02030200

Bijsluiter

PACKAGE LEAFLET:
INFORMATION FOR THE USER
AMIODARONE 100 MG TABLETS
AMIODARONE 200 MG TABLETS
(Amiodarone Hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor, pharmacist or nurse.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
•
If you get any side effects, talk to you doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Amiodarone Tablets are and what they
are used for
2.
What you need to know before you take
Amiodarone Tablets
3.
How to take Amiodarone Tablets
4.
Possible side effects
5.
How to store Amiodarone Tablets
6.
Contents of the pack and other information 1. WHAT AMIODARONE TABLETS ARE AND
WHAT THEY ARE USED FOR
Amiodarone 100mg or 200mg Tablets (called
Amiodarone 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.
Amiodarone 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”.
Amiodarone Tablets are used only when other
medicines can not be used.
•
Treat fast heartbeats which may happen
suddenly and may be uneven. Amiodarone
Tablets are used only when other medicines
cannot be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMIODARONE TABLETS
DO NOT TAKE AMIODARONE TABLETS IF
•
you are allergic (hypersensiti

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of amiodarone hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White to off white flat round bevelled edge uncoated tablets with
inscription AY on
one side and scoreline on other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
should
be
initiated
and
normally
monitored
only
under
hospital
or
specialist supervision. Oral amiodarone is indicated only for the
treatment of severe
rhythm disorders not responding to other therapies or when other
treatment 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 regiment is generally effective:
Initial stabilisation:
Treatment should be started with 200mg, three times a day and may be
continued for
1 week.
The dosage should then be reduced to 200mg twice daily for a further
week.
Maintenance:
After the initial period the dosage should be reduced to 200mg daily,
or less if
appropriate.
Rarely, the patient may require a higher maintenance dose. The scored
100mg 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 200mg 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 believed