IMDUR 60MG TABLET

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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资料单张 资料单张 (PIL)
03-11-2017
产品特点 产品特点 (SPC)
05-09-2017

有效成分:

ISOSORBIDE-5-MONONITRATE

可用日期:

ZUELLIG PHARMA SDN BHD

INN(国际名称):

ISOSORBIDE-5-MONONITRATE

每包单位数:

28Tablet Tablets; 30 Tablet Tablets; 105 Tablet Tablets

厂商:

AstraZeneca Pharmaceutical Co. Ltd.

资料单张

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IMDUR
®
Isosorbide-5-mononitrate 30mg, 60mg
1
WHAT IS IN THIS LEAFLET
1.
What Imdur ® is used for
2.
How Imdur ® works
3.
Before you use Imdur ®
4.
How to use Imdur ®
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of
Imdur ®
8.
Product Description
9.
Manufacturer and
Product
Registration
Holder
10.
Date of revision
WHAT IMDUR ® IS USED FOR
Imdur
is
used
as
preventive
treatment of vascular spasm in the
heart (angina pectoris).
HOW IMDUR ® WORKS
Imdur
works
by
widening
the
blood vessels and so making the
work of the heart easier in the case
of vascular spasm in the heart.
BEFORE YOU TAKE IMDUR ®
-
_When you must not take it_
You must not use Imdur in the
following cases :
• in shock
• in low blood pressure
• in disease of the heart muscles
(constrictive cardiomyopathy)
• in certain diseases of the
pericardium (constrictive
pericarditis, pericardial
tamponade)
• at the same time as
phosphodiesterase type 5
inhibitors, such as Viagra
(sildenafil), Cialis (tadalafil) and
Levitra (vardenafil)
• if you are hypersensitive to any
of the ingredients
-
_Before you start use it_
Talk
to
your
doctor
before
you
start
using
Imdur
if
you
suffer
from any of the following:
• brain damage
• heart disease
•
reduced
oxygen
level
in
the
blood (hypoxaemia)
• blood deficiency (anaemia)
•
reduced thyroid gland function
(hypothyroidism)
-
_Taking other medicines_
Inform
your
doctor
if
you
are
taking any other medication at the
same
time
as
Imdur.
Certain
medicines
may
affect
or
be
affected by treatment with Imdur.
When you are treated with Imdur
you
must
not
use
phosphodiesterase
type
5
inhibitors,
such
as
Viagra
(sildenafil),
Cialis
(tadalafil)
and
Levitra
(vardenafil),
which
are
used
for
impotence
(erectile
dysfunction).
HOW TO TAKE
IMDUR ®
-
_How much to take_
Your doctor will determine the dose
that is suitable for you. The usual
dose
is
60
mg
once
daily.
-
_When to take it_
The tablets for the lower strengths,
30 mg and 60 mg, are di
                                
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产品特点

                                Imdur	
Isosorbide-5-mononitrate
Tablets 30 mg & 60 mg
Qualitative and Quantitative Composition
One prolonged release tablet contains: isosorbide mononitrate 30 mg or 60 mg.
For excipients see List of excipients.
Pharmaceutical Form
Prolonged release tablet
30 mg: Pink, oval with score, marked A/II, 7x13 mm.
60 mg: Pale yellow, oval with score, marked A/ID, 7 x 13 mm.
Therapeutic indications
Prophylactic treatment of angina pectoris.
Posology and method of administration
Imdur is intended for prophylactic treatment. The dosage is individual and must be titrated
according to clinical response. Imdur prolonged release tablets are taken once daily, in the
morning.
When initiating treatment, in order to avoid headache, 30 mg may be given for the first 2-4
days.
Normal dosage: 60 mg daily. If necessary the dose may be increased to 120 mg daily.
There is a risk of tolerance development with nitrate therapy. It is therefore important that
Imdur is taken once daily in order to obtain intervals with low nitrate concentrations and thus
reduce the risk of tolerance development.
If necessary, Imdur may be combined with beta-adrenoreceptor blockers and calcium
antagonists.
Administration
The tablets for the lower strengths, 30 and 60 mg, are dividable. The whole or divided tablet
should not be chewed or crushed and should be swallowed together with ½ glass of fluid.
Contraindications
Shock, hypotension, constrictive cardiomyopathy, constrictive pericarditis and pericardial
tamponade.
Hypersensitivity to the active ingredient or any excipients. Concomitant treatment with
Phospodiesterase type 5 Inhibitors (e.g. sildenafil).
                                
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资料单张 资料单张 马来文 03-11-2017

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