CAPTOPRIL SANDOZ Captopril 12.5mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

captopril

Saatavilla:

Sandoz Pty Ltd

Valtuutuksen tilan:

Registered

Pakkausseloste

CAPTOPRIL SANDOZ
®
_captopril dihydrate tablets_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Captopril 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 risks of you taking this medicine
against the benefits they expect it
will 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 CAPTOPRIL
SANDOZ IS USED
FOR
This medicine is used to treat:
•
high blood pressure
(hypertension)
•
certain heart conditions
•
certain kidney conditions
associated with diabetes.
It contains the active ingredient
captopril.
Captopril belongs to a group of
medicines called angiotensin
converting enzymes (ACE)
inhibitors.
It works by widening your blood
vessels, which reduces pressure in
the vessels. This makes it easier for
your heart to pump blood around
your body, and helps your kidneys
work better.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CAPTOPRIL SANDOZ
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
captopril, the active ingredient, or
to any of the other ingredients
listed at the end of this leaflet
under Product Description.
•
any other similar medicines such
as ACE inhibitors. Examples
include perindopril (Coversyl
®
),
ramipril (Tritace
®
) and enalapril
(Renitec
®
).
Some of the symptoms of an allergic
reaction may 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 A HISTO

Valmisteyhteenveto

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Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
CAPTOPRIL SANDOZ
®
(CAPTOPRIL)
1
NAME OF THE MEDICINE
Captopril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Captopril Sandoz
®
12.5 mg film coated tablet contains 12.5 mg captopril.
Each Captopril Sandoz
®
25 mg film coated tablet contains 25 mg captopril.
Each Captopril Sandoz
®
50 mg film coated tablet contains 50 mg captopril.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect: _
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Captopril Sandoz
®
12.5 mg film coated tablets are round tablets with a “snap tab”
break mark
on one side, convex on the other side, uniform white surface –
diameter 6.0 - 6.2 mm.
Captopril Sandoz
®
25 mg film coated tablets are round tablets of a “cloverleaf”
shape with
facet and a crossed break mark on both sides, uniform white surface
– diameter 8.0 - 8.2 mm.
Captopril Sandoz
®
50 mg film coated tablets are round tablets of a “cloverleaf”
shape with
facet and a crossed break mark on both sides, uniform white surface
– diameter 10.0 - 10.2
mm.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_HYPERTENSION _
Captopril Sandoz is indicated for the treatment of hypertension.
In
using
Captopril
Sandoz,
consideration
should
be
given
to
the
risk
of
neutropenia/agranulocytosis (see Section 4.4 Special warnings and
precautions for use).
Captopril Sandoz is effective alone and in combination with other
antihypertensive agents,
especially thiazide-type diuretics. The blood pressure lowering
effects of captopril and
thiazides are approximately additive.
_MYOCARDIAL INFARCTION _
Captopril Sandoz is indicated to improve survival following myocardial
infarction in clinically
stable patients with left ventricular dysfunction, manifested as an
ejection fraction ≤ 40%, and
to reduce the incidence of overt heart failure and subsequent
hospitalisations for congestive
heart failure in these patients. The efficacy