AMIODARONE SANDOZ amiodarone hydrochloride 200mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

amiodarone hydrochloride, Quantity: 200 mg

Dostupno od:

Sandoz Pty Ltd

Farmaceutski oblik:

Tablet, uncoated

Sastav:

Excipient Ingredients: lactose monohydrate; magnesium stearate; colloidal anhydrous silica; povidone; maize starch

Administracija rute:

Oral

Jedinice u paketu:

30 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Severe cases of tachyarrhythmias (e.g Wolf-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (eg thyroid function, chest X-ray, ophthalmological examination, hepatic function) during the entire course of therapy and for several months after discontinuation.

Proizvod sažetak:

Visual Identification: White, round tablets, biconvex with score on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2001-03-02

Uputa o lijeku

AMIODARONE SANDOZ
®
1
AMIODARONE
SANDOZ
®
_amiodarone hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amiodarone Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking Amiodarone
Sandoz against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AMIODARONE
SANDOZ IS USED FOR
Amiodarone Sandoz is used to
control a fast or irregular heart beat.
It contains the active ingredient
amiodarone hydrochloride.
Amiodarone hydrochloride belongs
to a group of medicines called
antiarrhythmics.
It works by lengthening the gap
between one heart beat and the next,
thus helping to bring the heart rate to
a slower and more regular pace.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Amiodarone Sandoz is not
recommended for children.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE
AMIODARONE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMIODARONE SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
amiodarone hydrochloride, the
active ingredient, or iodine, or
any of the inactive ingredients
mentioned at the end of this
leaflet under Product Description
•
any other similar medicines.
Symptoms of an allergic reaction
include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
thyroid problems
•
heart problems that may cause
you to faint. If you have a
pacemaker, your doctor may
allow the use of it.
•
severe breathing problems
�

Svojstava lijeka

190827-Amiodarone Sandoz-pi
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
AMIODARONE SANDOZ (AMIODARONE HYDROCHLORIDE) TABLETS
1.
NAME OF THE MEDICINE
Amiodarone hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Amiodarone Sandoz 100 mg tablets contains 100 mg amiodarone
hydrochloride.
Each Amiodarone Sandoz 200 mg tablets contains 200 mg amiodarone
hydrochloride.
_Excipients with known effect:_
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AMIODARONE SANDOZ 100 mg tablets: white, round tablets, one side
convex, the other
side scored
AMIODARONE SANDOZ 200 mg tablets: white, round tablets, biconvex with
one-sided
score notch
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome;
supraventricular,
nodal and ventricular tachycardias; atrial flutter and fibrillation;
ventricular fibrillation) not
responding to other therapy. Treatment should be initiated in
hospital. It is recommended that
the patient should be regularly monitored for possible toxicity (e.g.
thyroid function, chest X-
ray, ophthalmological examination, hepatic function) during the entire
course of therapy and
for several months after discontinuation.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Due to poor absorption and wide interpatient variability of
absorption, the initial loading and
subsequent maintenance, dosage schedules in clinical use of the drug
have to be individually
titrated. 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 usually effective.
_ADULTS _
_Initial stabilisation _
Treatment should be started with 200 mg three times daily and may be
continued for one 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 appro