Amiodarone 200mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Amiodarone hydrochloride

Beszerezhető a:

DE Pharmaceuticals

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

SPACE FOR
PC NO.
FRONT
BACK
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE 100 MG TABLETS
AMIODARONE 200 MG TABLETS
amiodarone hydrochloride
Your medicine is called Amiodarone 100 mg and 200 mg Tablets, but it
will
be referred to as Amiodarone Tablets throughout this leaflet.
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 or pharmacist
•
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 or pharmacist. 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 contain a medicine called amiodarone hydrochloride.
This belongs to a group of medicines called antiarrhythmics.
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 cannot 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 AMIODA

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amiodarone 200 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of amiodarone hydrochloride.
Excipients with known effect:
Each tablet contains 50mg lactose monohydrate
For the full list of the excipients: see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Diameter: 9.5mm.
Amiodarone 200mg Tablets are round, white, flat tablets with a central
division line
on one face and embossed “200” on the reverse.
The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Oral Amiodarone hydrochloride is 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.
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 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 scored
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 wher