Amiodarone 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiodarone hydrochloride

Available from:

Almus Pharmaceuticals 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

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone Hydrochloride 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of amiodarone hydrochloride.
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, bevelled edge tablets, embossed with breakline on one
side and
plain on the other side with an approximate diameter of 9.5mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Oral Amiodarone Hydrochloride 200mg Tablets
are 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.
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
wellbeing.
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 dosage
should be titrated to the minimum 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 h