Amiodarone 100mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Amiodarone hydrochloride

Dostupno od:

Almus Pharmaceuticals Ltd

ATC koda:

C01BD01

INN (International ime):

Amiodarone hydrochloride

Doziranje:

100mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 02030200

Uputa o lijeku

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

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone hydrochloride 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Amiodarone Hydrochloride 100mg tablet contains 100mg amiodarone
hydrochloride.
Excipients with known effect:
This medicinal product contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
_AMIODARONE HYDROCHLORIDE 100MG TABLETS: _
Amiodarone Tablets 100mg are white, flat, with a breakline and marked
with "100"
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Amiodarone Tablets are 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 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
Posology
_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 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 dos