DP-Captopril

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Captopril 5 mg/mL

זמין מ:

Douglas Pharmaceuticals Limited

כמות:

5 mg/mL

טופס פרצבטיות:

Oral solution

הרכב:

Active: Captopril 5 mg/mL Excipient: Citric acid monohydrate Disodium edetate Purified water Sodium benzoate Sodium citrate

סוג מרשם:

Prescription

סממני תרפויטית:

DP-Captopril is indicated for the treatment of hypertension. In using DP-Captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see Section 4.4 Special Warnings and Precautions for Use). DP-Captopril 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.

leaflet_short:

Package - Contents - Shelf Life: Bottle, glass, Type III Amber with CR cap, 3mL dosing syringe, 30mL measuring cup - 95 mL - 24 months from date of manufacture stored at or below 30°C 21 days opened stored at or below 30°C - Bottle, glass, Type III Amber with CR cap, 3mL dosing syringe, 30mL measuring cup - 100 mL - 24 months from date of manufacture stored at or below 30°C 21 days opened stored at or below 30°C

תאריך אישור:

2021-01-11

עלון מידע

CONSUMER MEDICINE INFORMATION
1
DP-CAPTOPRIL
_Captopril _
5 mg/mL Oral Solution
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING DP-CAPTOPRIL
This
leaflet
answers
some
common
questions
about DP-Captopril. 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 DP-Captopril
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 DP-CAPTOPRIL IS USED FOR
DP-Captopril is used for the treatment of 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 DP-Captopril every day.
DP-Captopril
belongs
to
a
group
of
medicines
called
Angiotensin
Converting
Enzyme
(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 heart or kidneys
to work better.
Your doctor may have prescribed DP-Captopril for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY DP-CAPTOPRIL HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU USE DP-CAPTOPRIL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DP-CAPTOPRIL IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing captopril, or a class of
medicines called ACE inhibitors.
•
any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or
•
other parts of the body
•
hives on the skin, rash, or itching.
DO NOT TAKE DP-CAPTOPRIL IF YOU HAVE A HISTORY OF
BLOOD VESSEL SWELLING WITH

מאפייני מוצר

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DP-Captopril (captopril 5 mg/mL oral solution)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DP-Captopril oral solution contains 5 mg of captopril.
EXCIPIENT(S) WITH KNOWN EFFECT
DP-Captopril contains sodium benzoate as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DP-Captopril contains captopril 5 mg/mL and is a clear, colourless
oral solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
HYPERTENSION
DP-Captopril is indicated for the treatment of hypertension.
In using DP-Captopril, consideration should be given to the risk of
neutropenia/agranulocytosis
see section 4.4
DP-Captopril 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
DP-Captopril is indicated to improve survival following myocardial
infarction in clinically stable
patients with left ventricular dysfunction, manifested as an ejection
fraction less than or overall
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.
2 | P a g e
HEART FAILURE
DP-Captopril is indicated for the treatment of heart failure. In
symptomatic patients it is
recommended that DP-Captopril be administered together with a
diuretic.
TYPE I DIABETIC NEPHROPATHY
DP-Captopril is indicated for the treatment of diabetic nephropathy in
patients with Type 1 insulin-
dependent diabetes mellitus.
4.2.
DOSE AND METHOD OF ADMINISTRATION
A first dose hypotensive effect, severe in some patients may occur. To
minimise this effect, the
dosage should be individualised and titrated from a low starting dose
to the maintenance dose.
DP-Captopril should be taken one hour before meals.
HYPER