Amiodarone 100mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Amiodarone hydrochloride

Dostupné z:

Waymade Healthcare Plc

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

Príbalový leták

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 before 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 (hypersensiti

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone 100 mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 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
“100” 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 Amioda