Amiodarone 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiodarone hydrochloride

Available from:

Accord-UK Ltd

ATC code:

C01BD01

INN (International Name):

Amiodarone hydrochloride

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 5060149310052

Patient Information leaflet

AMIODARONE 100MG AND 200MG TABLETS
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 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 tablets belong to a group of medicines called
anti-arrhythmics. They work by regulating the
heart rate.
Amiodarone tablets may be used to treat:
•
severe disturbances of normal heart rhythm and irregular heart rhythm
when other drugs cannot be used
•
all types of irregular heartbeats of a sudden nature including a
racing heart and an irregular heart rhythm
when other drugs cannot be used
•
Wolff-Parkinson-White Syndrome
•
or restore a normal heart rhythm and maintain it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE TABLETS
DO NOT TAKE
Amiodarone tablets and
TELL
your doctor if you:
•
are
ALLERGIC
(hypersensitive) to amiodarone hydrochloride, iodine or any of the
other ingredients of this
medicine (see section 6)
•
suffer from
CONDUCTION PROBLEMS OF THE HEART
, such as a slow heartbeat or heart block. Amiodarone
tablets should only be used in such patients who have a pacemaker
fitted
•
have
THYROID DISEASE
or have not yet had your thyroid function tested
•
have
SEVERELY LOW BLOOD PRESSURE
•
have
SEVERE BREATHING DIFFICULTIES
•
are
TAKING THE FOLLOWING
ot

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AMIODARONE TABLETS BP 200mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
200mg of Amiodarone hydrochloride.
3
PHARMACEUTICAL FORM
Tablet.
White, circular, uncoated tablet impressed “C” and the identifying
letters “RE”
on either side of a central division line on one face, with the
reverse plain.
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
treatment 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 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 a