Amiodarone 200mg tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

AMIODARONE HYDROCHLORIDE

Доступна з:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Код атс:

C01BD01

ІПН (Міжнародна Ім'я):

AMIODARONE HYDROCHLORIDE 200 mg

Фармацевтична форма:

TABLET

Склад:

AMIODARONE HYDROCHLORIDE 200 mg

Тип рецепту:

POM

Терапевтична области:

CARDIAC THERAPY

Статус Авторизація:

Authorised

Дата Авторизація:

2007-04-20

інформаційний буклет

PILAMIOTAB5.1-CY
© MEDOCHEMIE LTD
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE 200MG TABLETS
Amiodarone HCl
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 or your pharmacist.
-
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 your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4..
WHAT IS IN THIS LEAFLET
:
1.
What Amiodarone is and what it is used for
2.
What you need to know before you take Amiodarone
3.
How to take Amiodarone
4.
Possible side effects
5
How to store Amiodarone
6.
Contents of the pack and other information
1.
WHAT AMIODARONE IS AND WHAT IT IS USED FOR
Amiodarone 200mg tablets 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 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 is used only when other medicines cannot be used.
Treat fast heartbeats which may happen suddenly and may be uneven.
Amiodarone is used only when
other medicines cannot be used.
PILAMIOTAB5.1-CY
© MEDOCHEMIE LTD
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE
DO NOT TAKE AMIODARONE
:
_ _
•
You are allergic (hypersensitive) to:
-
iodine,
-
amiodarone,
-
any of the other ingredients of this medicine (listed in Section 6).
Signs of an allergic

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amiodarone 200mg tablets
2.
QUALITATIVE AND QUANTITAVE COMPOSITION
Each tablet contains 200 mg amiodarone HCl
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, flat, scored tablets.
The score line is not intended for breaking the tablet.
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 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
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
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 to be
related to high tissue levels of amiodarone and its metabolites.
Amiodarone is strongly protein bound and has an average plasma half
life of