Cardilor 200 Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

AMIODARONE HYDROCHLORIDE

Dostępny od:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Kod ATC:

C01BD01

INN (International Nazwa):

AMIODARONE HYDROCHLORIDE 200 mg

Forma farmaceutyczna:

TABLET

Skład:

AMIODARONE HYDROCHLORIDE 200 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

CARDIAC THERAPY

Status autoryzacji:

Authorised

Data autoryzacji:

2007-07-30

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARDILOR 200 MG TABLETS
AMIODARONE HYDROCHLORIDE
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE 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 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 Cardilor is and what it is used for
2.
What you need to know before you take Cardilor
3.
How to take Cardilor
4.
Possible side effects
5.
How to store Cardilor
6.
Contents of the pack and other information
1.
WHAT CARDILOR IS AND WHAT IT IS USED FOR
Cardilor 200 mg tablets (called Cardilor in this leaflet) contain a
medicine called amiodarone
hydrochloride. This belongs to a group of medicines called
antiarrhythmics.
It works by controlling the uneven beating of your heart (called
‘arrhythmias’). Taking the
tablets helps your heartbeat to return to normal.
Cardilor 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’. Cardilor tablets are used only when other medicines
cannot be used.
-
treat fast heartbeats which may happen suddenly and may be uneven.
Cardilor tablets are
used only when other medicines cannot be used.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDILOR
DO NOT TAKE CARDILOR:
-
if you are allergic to iodine.
-
if you allergic to amiodarone or any other ingredients of Cardilor
(listed in section 6).
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Signs

Charakterystyka produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cardilor 200 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg amiodarone hydrochloride.
Excipient(s) with known effect
This product contains 69 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or specialist
supervision. Cardilor 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
_ _
_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.
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PAGE 2 OF 15
INITIAL STABILISATION
Treatment should be started with 200 mg, three times a day and may be
continued for 1 week.
The dosage should then be reduced to 200 mg, twice daily for a further
week.
MAINTENANCE
After the initial period the dosage should be reduced to 200 mg 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 200 mg daily.
GENERAL CONSIDERATIONS
Initial dosing: A high dose is needed in order to achieve adequate
tissue levels rapidly.
Maintenance: Too high a dose durin