Amiodarone 200mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Amiodarone hydrochloride

Beszerezhető a:

Sigma Pharmaceuticals Plc

ATC-kód:

C01BD01

INN (nemzetközi neve):

Amiodarone hydrochloride

Adagolás:

200mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02030200

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMIODARONE HYDROCHLORIDE 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 your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in the leaflet. See section 4.
The name of your medicine is Amiodarone Hydrochloride 200 mg tablets;
however for simplicity it
will be referred to as Amiodarone throughout the leaflet.
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
Your tablet contains amiodarone hydrochloride, which belongs to a
class of medicines known as
antiarrhythmics. Amiodarone can help to suppress and prevent an
abnormal or irregular heart rhythm
and so return your heart rhythm 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE
DO NOT TAKE AMIODARONE IF:
•
you are allergic to amiodarone or to any of the other ingredients of
this medicine (liste

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone 200 mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of amiodarone hydrochloride
For list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablet.
Round, white, flat tablet with a score line on one face and embossed
“200” on
the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision.
Oral Amiodarone is indicated 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 is 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 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
100 mg 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 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 during maintenance therapy can cause side effects
which are
believed to be related to high tissue levels of Amiodar