PROART TABLETS 62.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BOSENTAN MONOHYDRATE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BOSENTAN MONOHYDRATE

Unit dalam pakej:

1x15tablet Tablets; 15tablet Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

PROART TABLETS 62.5/125 MG
Page 1
PROART TABLETS 62.5 MG AND PROART TABLETS 125 MG
(Bosentan Monohydrate Tablets 62.5 mg and 125 mg)
_ _
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1. What
PROART TABLETS
are used
for
2. How
PROART TABLETS
work
3. Before you use
PROART TABLETS
4. How to use
PROART TABLETS
5. While you are using it
6. Side effects
7. Storage and Disposal of
PROART
TABLETS
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
This leaflet answers some common
questions about
PROART TABLETS.
It does not contain all of 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
PROART TABLETS
against
the benefits it is expected to 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 PROART TABLETS ARE USED FOR
PROART TABLETS
contain the active
ingredient bosentan. It is used for the
treatment of high blood pressure in the
blood vessels between the heart and the
lungs.
This
condition
is
called
pulmonary arterial hypertension.
HOW PROART TABLETS WORK
PROART
TABLETS
contain
bosentan
which
belongs
to
the
class
of
medicines called “endothelin receptor
antagonists”.
Bosentan blocks a naturally occurring
hormone
called
endothelin-1
(ET-1),
which causes blood vessels to narrow.
Thus, it acts to reduce abnormally high
blood
pressure
by
widening
these
blood vessels.
Your
doctor
however,
may
have
prescribed
this
medicine
for
another
purpose.
Ask
your
doctor
if
you
have
any
questions why it has been prescribed
for you.
This medicine is only available with a
doctor’s prescription.
BEFORE YOU USE PROART TABLETS
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE PROART TABLETS:

If you are allergic to bosentan or
any of the other ingredients of this
medicine (see product description
at
the
end
of
this
leaflet).

Ciri produk

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
PROART TABLETS 62.5 MG AND PROART TABLETS 125 MG
(Bosentan Monohydrate Tablets)
COMPOSITION
PROART 62.5 MG
Each film coated tablet contains:
Bosentan Monohydrate equivalent to
Bosentan …………. 62.5 mg
PROART 125 MG
Each film coated tablet contains:
Bosentan Monohydrate equivalent to
Bosentan …………. 125 mg
Excipients: Maize starch, Pregelatinized starc., Sodium starch
glycolate, Povidone, Purified water,
Glyceryl
behenate,
Magnesium
stearate,
Isopropyl
alcohol
and
Opadry
21K520019
(Yellow)
containing Hypromellose, Titanium Dioxide, Triacetin, Talc,
Ethylcellulose, Iron Oxide Yellow,
Hpmc /Hypromellose and Iron Oxide Red.
DESCRIPTION
For 62.5 mg
Light peach to peach colored film coated round shaped biconvex tablet
debossed with '62.5' on
one side and plain the other side.
For 125 mg
Light peach to peach colored film coated Oval shaped biconvex tablet
debossed with ‘125' on one
side and plain the other side.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
1
_Mechanism of action _
Bosentan is a dual endothelin receptor antagonist (ERA) with affinity
for both endothelin A and B
(ET
A
and ET
B
) receptors. Bosentan decreases both pulmonary and systemic vascular
resistance
resulting in increased cardiac output without increasing heart rate.
The neurohormone endothelin-1 (ET-1) is one of the most potent
vasoconstrictors known and can
also
promote
fibrosis,
cell
proliferation,
cardiac
hypertrophy
and
remodelling,
and
is
pro-
inflammatory. These effects are mediated by endothelin binding to ET
A
and ET
B
receptors located
in the endothelium and vascular smooth muscle cells. ET-1
concentrations in tissues and plasma
are increased in several cardiovascular disorders and connective
tissue diseases, including PAH,
scleroderma, acute and chronic heart failure, myocardial ischaemia,
systemic hypertension and
atherosclerosis, suggesting a pathogen