Amiodarone 100mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Amiodarone hydrochloride

Dostupné z:

Arrow Generics Ltd

ATC kód:

C01BD01

INN (Medzinárodný Name):

Amiodarone hydrochloride

Dávkovanie:

100mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02030200; GTIN: 5060034831594

Príbalový leták

1
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 b
efore 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 (hypersensitive

Súhrn charakteristických

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