Amiodarone 200mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-05-2017
Summary of Product characteristics
(SPC)
24-12-2019
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Amiodarone hydrochloride
Available from:
Teva 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: 5017007028116
Patient Information leaflet
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
Read the complete document
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
Read the complete document
