BIO-AMIODARONE TABLET

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Biotech Laboratories (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200,0 mg

Estado de Autorización:

Registered

Fecha de autorización:

2004-12-01

Información para el usuario

Biotech Laboratories (Pty) Ltd
Bio-Amiodarone
(Amiodarone hydrochloride)
200 mg tablets
1.5.5.4
Page 1 of 13
PATIENT INFORMATION LEAFLET FOR BIO-AMIODARONE
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
BIO-AMIODARONE 200 MG TABLETS
AMIODARONE HYDROCHLORIDE
CONTAINS SUGAR (LACTOSE MONOHYDRATE): 50 MG PER TABLET.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
BIO-AMIODARONE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
BIO-AMIODARONE has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET:
1.
What BIO-AMIODARONE is and what it is used for
2.
What you need to know before BIO-AMIODARONE is taken
3.
How to take BIO-AMIODARONE
4.
Possible side effects
5.
How to store BIO-AMIODARONE
6.
Contents of the pack and other information
Biotech Laboratories (Pty) Ltd
Bio-Amiodarone
(Amiodarone hydrochloride)
200 mg tablets
1.5.5.4
Page 2 of 13
1.
WHAT BIO-AMIODARONE IS AND WHAT IT IS USED FOR
BIO-AMIODARONE belongs to a group of medicines called
anti-dysrhythmics.
It works by controlling the uneven beating of your heart (called
‘dysrhythmias’). BIO-AMIODARONE
is used to:
•
Treat uneven heartbeats where other medicines either have not worked
or cannot be used.
•
Treat t 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’.
•
Treat fast heartbeats which may happen suddenly and may be uneven.
BIO-AMIODARONE is
used only when other medicines cannot be used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIO-AMIODARONE
DO NOT TAKE BIO-AMIODARONE IF YOU:
•
Are hypersensitive (allergic) to amiodarone, iodine or any of the
other ingredients of BIO-
AMIODARONE (listed in section 6).
•
Have a slower than usual heartbeat (

Ficha técnica

Biotech Laboratories (Pty) Ltd
Bio-Amiodarone
(Amiodarone hydrochloride)
200 mg tablets
1.5.5.3
Page 1 of 22
PROFESSIONAL INFORMATION FOR BIO-AMIODARONE
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
BIO-AMIODARONE 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg amiodarone hydrochloride.
_Excipient with known effect:_
Contains sugar (lactose monohydrate): 50 mg per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Scored, flat, white tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of tachydysrhythmias associated with Wolff-Parkinson-White
syndrome and other types
of
tachydysrhythmias
of
paroxysmal
nature
including
supraventricular,
nodal
and
ventricular
tachycardia, atrial flutter, atrial fibrillation, and ventricular
fibrillation when other medicines cannot be
used.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Biotech Laboratories (Pty) Ltd
Bio-Amiodarone
(Amiodarone hydrochloride)
200 mg tablets
1.5.5.3
Page 2 of 22
POSOLOGY
It is particularly important that the minimum effective dose be used.
In all cases the patient
management must be judged on the individual response and wellbeing.
_Initial treatment:_
The usual dosage is 200 mg, 3 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 treatment:_
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 dosage should be titrated to the minimum dosage required to
maintain control of the
dysrhythmia. The maintenance dose should be regularly reviewed,
especially where this exceeds
200 mg daily.
_Changeover from intravenous to oral therapy: _
Oral therapy should be initiated concomitantly at the usual loading
dose i.e., 200 mg three times a
day, as soon as possible after an adequate response has been obtained
using amiodarone
intravenous, which should then be phased out gradually.
_General