Amiodarone 200mg 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:

200mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02030200; GTIN: 5060034831600

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 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of amiodarone hydrochloride.
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, bevelled edge tablets, embossed with breakline on one
side and
plain on the other side with an approximate diameter of 9.5mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Oral Amiodarone Hydrochloride 200mg 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 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.
Tablets are used for stabilisation and long term treatment.
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
wellbeing.
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 dosage
should be titrated to the minimum 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 h