EBERIL 60mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
05-11-2020
Ciri produk Ciri produk (SPC)
25-01-2021

Bahan aktif:

ETORICOXIB

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

ETORICOXIB

Unit dalam pakej:

3x10 Tablets; 10x10 Tablets

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EBERIL 60MG/90MG/120MG TABLET
Etoricoxib (60 mg, 90 mg and 120 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Eberil is used for
2.
How Eberil works
3.
Before you take Eberil
4.
How to take Eberil
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Eberil
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EBERIL IS USED FOR
YOUR
DOCTOR
HAS
PRESCRIBED
EBERIL
TABLET FOR:
•
Treatment of osteoarthritis
•
Treatment of rheumatoid arthritis
•
Treatment of ankylosing spondylitis
•
Treatment of acute pain after minor
dental procedures
•
Treatment of menstrual pain
•
Treatment of gout attacks
Osteoarthritis is a joint disease. It results
from
the
gradual
breakdown
of
the
cartilage that cushions the ends of the
bones, resulting in pain, inflammation,
tenderness,
stiffness,
and
physical
disability.
Rheumatoid arthritis is a chronic disease
that causes pain, stiffness, swelling and
loss
of
function
in
the
joints
and
inflammation in other body organs.
Ankylosing
spondylitis
is
an
inflammatory disease of the spine and
large joints.
Gout
is
a
disorder
characterized
by
sudden, recurring attacks of pain and
inflammation in one or more joints.
HOW EBERIL WORKS
Eberil tablet is a member of a group of
medicines
called
selective
COX-2
inhibitors that are used to reduce pain
and inflammation. Eberil tablet is not a
narcotic.
BEFORE YOU TAKE EBERIL
_- When you must not use it _
Do not take Eberil if you:
•
are allergic to any of its ingredients
•
have heart failure, a heart attack,
bypass surgery, chest pain, narrow
or
blocked
arteries
of
the
extremities, a stroke or mini stroke
•
have high blood pressure that has
not been controlled by treatment
_- Before you start to use it _
Tell
your
doctor
about
any
medical
problems or allergies you have now or
have had, including:
•
History of angina, heart attack or a
blocked artery in your heart
•
Narrow
or
blocked
arteries
of
the
extr
                                
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Ciri produk

                                1 of 7
EBERIL 60
EBERIL 90
EBERIL 120
Each film coated tablet contains:
ETORICOXIB 60 MG
ETORICOXIB 90 MG
ETORICOXIB 120 MG

PRODUCT DESCRIPTION:
_60 MG: _
Green, apple-shaped, biconvex, film coated tablet with engraved 60 on
one side and plain on the other side
_90 MG: _
White, apple-shaped, biconvex, film coated tablet with engraved 90 on
one side and scored on the other side
_120 MG: _
Pale-green, apple-shaped, biconvex, film coated tablet with engraved
120 on one side and scored on the other
side

MECHANISM OF ACTION:
_PHARMACOLOGY _
Etoricoxib
is
a
non-steroidal
anti-inflammatory
drug
(NSAID)
that
exhibits
anti-inflammatory,
analgesic,
and
antipyretic activities in animal models. Etoricoxib is a potent,
orally active, highly selective cyclooxygenase-2 (COX-
2) inhibitor within and above the clinical dose range. Two isoforms of
cyclo-oxygenase have been identified:
cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is
responsible for prostaglandin-mediated normal
physiologic functions such as gastric cytoprotection and platelet
aggregation. Inhibition of COX-1 by nonselective
NSAIDs has been associated with gastric damage and platelet
inhibition. COX-2 has been shown to be primarily
responsible for the synthesis of prostanoid mediators of pain,
inflammation, and fever. Selective inhibition of COX-2
by Etoricoxib decreases these clinical signs and symptoms with
decreased GI toxicity and without effects on platelet
function.
Etoricoxib produces dose-dependent inhibition of COX-2 without
inhibition of COX-1 at doses up to 150 mg daily.
Platelet Function
Multiple doses of Etoricoxib up to 150 mg administered daily up to
nine days have no effect on bleeding time. There is
no inhibition of
_ex vivo_
arachidonic acid- or collagen-induced platelet aggregation at steady
state with doses of
Etoricoxib up to 150 mg. These findings are consistent with the COX-2
selectivity of Etoricoxib.
_ _
_PHARMACOKINETICS _
Absorption
Orally
administered
Etoricoxib
is
well
absorbed.
The
absolute
bioavailability
is
app
                                
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