IMDEX 60MG CR TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Isosorbide-5-mononitrate 70%

Boleh didapati daripada:

Duopharma Marketing Sdn. Bhd.

INN (Nama Antarabangsa):

Isosorbide-5-mononitrate 70%

Unit dalam pakej:

28Tablet Tablets; 28 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP) _
IMDEX CR TABLET
Isosorbide mononitrate 60mg
WHAT IS IN THE LEAFLET?
1.
What Imdex is used for
2.
How Imdex works
3.
Before you use Imdex
4.
How to use Imdex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Imdex
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IMDEX IS USED FOR
Imdex is used to prevent
angina. Angina is a pain or
uncomfortable feeling in the
chest, often spreading to the
arms or the neck and
sometimes to the shoulders and
back. This is caused by too
little blood and oxygen getting
to the heart. The pain of angina
is usually brought on by
exercise or stress.
HOW IMDEX WORKS
Imdex belongs to a group of
medicines
called
nitrates.
It
works
by
relaxing
the
blood
vessels, letting more blood and
oxygen reach the heart.
BEFORE YOU USE IMDEX
-
_When you must not take it _
Do not use Imdex if you are
allergic to it or medicine
containing nitrates or nitrites or
any ingredients listed at the end
of the leaflet.
Do not use Imdex if you have
the following medical
conditions:
•
Low blood pressure
•
Shock including those
caused
by low blood
pressure or
failing heart
•
Pericarditis
(swelling
around the heart)
•
Weakened muscle of the
heart
You must not use Imdex whilst
taking
sildenafil
(Viagra),
vardenafil (Levitra) or tadalafil
(Cialis).
Do not use Imdex if you are
pregnant
or
breast
feeding
unless
your doctor
says
it
is
safe. Ask your doctor about the
risks and benefits involved.
Do not give Imdex to children.
There
is
no
specific
information
about
use
in
children.
Always
ask
your
doctor before giving medicines
to children.
Do
not
use
after
the
use
by
(expiry)
date
printed
on
the
pack or if the packaging is torn
or shows signs of tampering.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should take this medicine, talk
to your doctor.
-
_Before you start to use it_
_You must tell your doctor if: _
1.
you have any allergies to

Ciri produk

IMDEX
TM
Isosorbide-5-mononitrate
60 mg CR Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION
One controlled release tablet contains:
Isosorbide mononitrate 60 mg
PHARMACEUTICAL FORM
Controlled release tablet
60 mg: Yellow, oval, biconvex, film coated, scored on one side and
marked with IM on the other side.
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
POSOLOGY AND METHOD OF ADMINISTRATION
is intended for prophylactic treatment. The dosage is individual and
must be titrated according to
clinical response. prolonged release tablets are taken once daily, in
the morning.
_When _
_initiating _
_treatment, _
_in _
_order _
_to _
_avoid _
_headache, _
_30 _
_mg _
_be _
_given _
_for _
_the _
_first _
_2-4 _
_days._
Normal dosage: 60 mg daily. If necessary the dose may be increased to
120mg daily. There is a risk of
tolerance development with nitrate therapy. It is therefore important
that is taken once daily in order to
obtain
intervals
with
low
nitrate
concentrations
and
thus
reduce
the
risk
of
tolerance
development.
If
necessary,
may
be
combined
with
beta-adrenoreceptor
blockers
and
calcium
antagonists.
_Administration_
The tablet is dividable. The whole or divided tablet of 60mg 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
ingredients
of
any
excipients.
Concomitant
treatment
with
Phosphodiesterase type 5 Inhibitors (eg sildenafil).
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Caution should be exercised in the treatment of patients with serious
cerebrovascular disease, increased
intracranial pressure, aortic stenosis, mitral stenosis and
hypertrophic obstructive cardiomyopathy, anaemia,
hypoxaemia and hypothyroidism.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
_The following combination with must be avoided:_
Phosphodiesterase type 5 Inhibitors (eg sildenafil): Administrati