Capoten 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

captopril, Quantity: 25 mg

Available from:

Arrow Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; stearic acid; microcrystalline cellulose; maize starch

Administration route:

Oral

Units in package:

90 Tablets (and sample packs 15's), 30 tablets (export only), 150 tablets (export only), 60 tablets (export only), 100 tablets (

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

1.HYPERTENSION: Capoten (captopril) is indicated for the treatment of hypertension. In using Capoten, consideration should be given to the risk of neutropenia/agranulocytosis (see PRECAUTIONS). Capoten 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. 2. MYOCARDIAL INFARCTION: Capoten is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less than or equal to 40%, and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. 3. HEART FAILURE: Capoten (captopril) is indicated for the treatment of heart failure. In symptomatic patients it is recom

Product summary:

Visual Identification: A square, bi-convex, slightly mottled white tablet with quadrisect score lines on one side and plain the other. Dimensions 6.4 mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

CAPOTEN- Consumer Medicine Information
Page 1 of 4
CAPOTEN

_captopril _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking
Capoten.
This
leaflet
answers
some
common
questions
about
Capoten.
It
does
not
contain
all
the
available information. Some of
the information it contains may
not apply to you. It does not
take the place of talking to your
doctor or pharmacist.
ALWAYS
FOLLOW
THE
INSTRUCTIONS THAT YOUR DOCTOR
AND
PHARMACIST
GIVE
YOU
ABOUT CAPOTEN.
ASK
YOUR
DOCTOR
OR
PHARMACIST IF YOU HAVE ANY
CONCERNS
ABOUT
TAKING
CAPOTEN.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. You may need to
read it again
WHAT
CAPOTEN
IS
USED FOR
Capoten
is
used
for
treating
high
blood
pressure
(hypertension),
certain
heart
conditions, and certain kidney
conditions
associated
with
diabetes. These are long term
(chronic
diseases)
so
it
is
important that you continue to
take your Capoten every day.
Capoten
contains
captopril.
Captopril belongs to a class of
medicines
known
as
ACE
inhibitors. ACE inhibitors work
to lower your blood pressure to
normal levels if it is too high.
Capoten also acts to help your
heart or kidneys to work better.
Your doctor will tell you why you
need to take Capoten. Never let
anyone else take your medicine.
There is no evidence that it is
addictive or habit forming.
This medicine is only_ _available
only with a doctor’s prescription.
Capoten is not recommended
for use in children as there have
been not enough studies of its
effects in children. However it
may be necessary for a child
with hypertension and kidney
problems to take this medicine,
if this is the case your doctor will
discuss all the possible risks
and benefits to the child before
starting therapy.
BEFORE
YOU
TAKE
CAPOTEN
_ _
_WHEN YOU MUST NOT TAKE _
_IT _
•
YOU
MUST
NOT
TAKE
CAPOTEN
IF
YOU
ARE
PREGNANT OR MAY BECOME
PREGNANT
•
MEDICAL CONDITIONS KNOW
AS IDIOPATHIC ANGIOEDEMA
OR HEREDITARY ANGIOEDEMA
•
YOU
MUST
NOT
TAKE
CAPOTEN IF YOU HAVE EVER
HAD AN ALLERGY TO CAPOTEN
OR ANY OF THE INGREDIENTS

Summary of Product characteristics

1
AUSTRALIAN PI – CAPOTEN (CAPTOPRIL)
1
NAME OF THE MEDICINE
Captopril.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPOTEN tablets come in three strengths and contain either 12.5 mg, 25
mg or 50 mg of
captopril.
CAPOTEN oral solution comes in one strength and contains 5 mg of
captopril per mL of
solution.
Excipients with known effect: sodium benzoate and lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CAPOTEN 12.5 MG TABLET contains captopril 12.5mg, white, scored,
capsule-shaped tablet
marked SQUIBB 450.
CAPOTEN 25 MG TABLET contains captopril 25mg, white, square, double
scored.
CAPOTEN 50 MG TABLET contains captopril 50mg, white, oval, scored.
CAPOTEN ORAL SOLUTION contains captopril 5 mg/mL, clear, colourless,
unsweetened, flavour
free.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPERTENSION: CAPOTEN (captopril) is indicated for the treatment of
hypertension.
2
In using CAPOTEN, consideration should be given to the risk of
neutropenia/agranulocytosis
(see section 4.4 Special warnings and precautions for use).
CAPOTEN 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: CAPOTEN is indicated to improve survival
following myocardial
infarction in clinically stable patients with left ventricular
dysfunction, manifested as an
ejection fraction less than or equal to 40% and to reduce the
incidence of overt heart
failure, and subsequent hospitalisations for congestive heart failure
in these patients. The
efficacy data for the use of CAPOTEN following myocardial infarction
are strongest for
initiation of therapy beyond 3 days post-infarct.
HEART FAILURE: CAPOTEN (captopril) is indicated for the treatment of
heart failure. In
symptomatic patients it is recommended that CAPOTEN be administered
together with a
diuretic.
DIABETIC NEPHROPATHY: CAPOTEN is indicated for the treatment of
diabetic