Etrobax 60 (Etoricoxib Tablets 60 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ETORICOXIB

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ETORICOXIB

Unit dalam pakej:

7 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

ETROBAX
Page 1
ETROBAX
(Etoricoxib Tablets 60/90/120 mg)
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1. What
ETROBAX
is used for
2. How
ETROBAX
works
3. Before you use
ETROBAX
4. How to use
ETROBAX
5. While you are using it
6. Side effects
7. Storage and Disposal of
ETROBAX
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
This leaflet answers some common
questions about
ETROBAX
.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking
ETROBAX
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.
WHAT ETROBAX IS USED FOR
ETROBAX
helps to reduce the pain
and
swelling
(inflammation)
in
the
joints
and
muscles
of
patients
with
osteoarthritis,
rheumatoid
arthritis,
ankylosing spondylitis and gout.
ETROBAX
is
also
used
to
relieve
short term pain, including cramp-like
pain or discomfort before or during a
menstrual period, and pain associated
with minor dental procedures.
OSTEOARTHRITIS
Osteoarthritis is a disease of the joints.
It results from the gradual breakdown
of cartilage that cushions the ends of
the
bones.
This
causes
swelling
(inflammation),
pain,
tenderness,
stiffness and disability.
RHEUMATOID ARTHRITIS
Rheumatoid
arthritis
is
a
long
term
inflammatory disease of the joints. It
causes
pain,
stiffness,
swelling,
and
increasing
loss
of
movement
in
the
joints
it
affects.
It
may
also
cause
inflammation
in
other
areas
of
the
body.
GOUT
Gout is a disease of sudden, recurring
attacks
of
very
painful
inflammation
and redness in the joints. It is caused by
deposits of mineral crystals in the joint.
ANKYLOSING SPONDYLITIS
Ankylosing
spondylitis
is
an
inflammatory disease of the spine and
large joints.
HOW ETROBAX WORKS
ETROBAX
contains
the
active
substances etoricoxib which belongs to
a group of medicines called selective
COX-2
inhibitor.
These
belong
to
a
family
of
medicines
known
as
non-
steroidal

Ciri produk

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
ETROBAX
(Etoricoxib Tablets 60/90/120 mg)
ETROBAX 60 MG:
Each film coated tablet contains
Etoricoxib……………….60 mg
ACTIVE INGREDIENT: Etoricoxib
INACTIVE
INGREDIENTS: Cellulose
microcrystalline,
calcium
hydrogen
phosphate
anhydrous,
croscarmellose
sodium,
magnesium
stearate,
opadry
II
green
35K510000
OPADRY COMPOSITION: Lactose monohydrate, HPMC 2910/hypromellose,
titanium dioxide, triacetin,
FD&C Blue #2/indigo carmine aluminum lake, iron oxide yellow
ETROBAX 90 MG:
Each film coated tablet contains
Etoricoxib……………….90 mg
ACTIVE INGREDIENT: Etoricoxib
INACTIVE
INGREDIENTS: Cellulose
microcrystalline,
calcium
hydrogen
phosphate
anhydrous,
croscarmellose
sodium,
magnesium
stearate,
opadry
II
white
35K580003
OPADRY COMPOSITION: Lactose monohydrate, HPMC 2910/hypromellose,
titanium dioxide, triacetin,
ETROBAX 120 MG:
Each film coated tablet contains
Etoricoxib……………….120 mg
ACTIVE INGREDIENT: Etoricoxib
INACTIVE
INGREDIENTS: Cellulose
microcrystalline,
calcium
hydrogen
phosphate
anhydrous,
croscarmellose
sodium,
magnesium
stearate,
opadry
II
green
32K510018
OPADRY COMPOSITION: Lactose monohydrate, HPMC 2910/hypromellose,
titanium dioxide, triacetin,
FD&C Blue #2/indigo carmine aluminum lake, iron oxide yellow
PRODUCT DESCRIPTION
ETROBAX 60 MG:
Green to dark green, film coated, round biconvex tablets, E60 debossed
on one side and plain on other
side
ETROBAX 90 MG:
White to off white, film coated, round biconvex tablets, E90 debossed
on one side and plain on other
side
ETROBAX 120 MG:
Light green to pale green, film coated round biconvex tablets, E120
debossed on one side and plain on
other side
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
MECHANISM OF ACTION
Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic
and antipyretic activities. Etoricoxib is a potent, orally active,
highly selective cyclooxygenase-2 (COX-
2) inhibitor withi