Coxeta FC tablets 120mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Etoricoxib

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Etoricoxib

Unit dalam pakej:

10x10 Tablets; 3x10 Tablets

Dikeluarkan oleh:

TEVA Gyogyszergyar Zrt.

Risalah maklumat

_ Consumer Medication Information Leaflet (RiMUP)_
COXETA FC TABLETS _ _
Etoricoxib (60mg, 90mg, 120mg)
1
WHAT IS IN THIS LEAFLET
1.
What Coxeta is used for
2.
How Coxeta work
3.
Before you use Coxeta
4.
How to take Coxeta
5.
While you are using Coxeta
6.
Side Effects
7.
Storage
and
Disposal
of
Coxeta
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT
COXETA IS USED FOR
Coxeta helps to reduce the pain
and swelling (inflammation) in
the joints and muscles of people
with
osteoarthritis,
rheumatoid
arthritis, ankylosing spondylitis
and gout.
Coxeta is also used for the short
term treatment of moderate pain
including that related to dental
surgery and menstrual pain.
HOW
COXETA WORK
Coxeta is a member of a group of
medicines called selective COX-
2
inhibitors
that
are
used
to
reduce pain and inflammation.
BEFORE YOU USE COXETA
_-When you must not take it _
Do not take Coxeta if you:
• are allergic to etoricoxib and
any of its ingredients
• have had heart failure, a heart
attack,
bypass
surgery,
peripheral arterial disease (poor
circulation in legs or feet due to
narrow or blocked arteries)
• have increased risk of heart
disease
such
as
a
stroke.
Etoricoxib may slightly increase
your
risk
of
heart
attack
and
stroke and this is why it should
not be used in those who have
already had heart problems or
stroke.
• have high blood pressure that
has
not
been
controlled
by
treatment.
•
are
allergic
to
non-steroidal
anti-inflammatory
drugs
(NSAIDs), including aspirin and
COX-2 inhibitors
• have a current stomach ulcer or
bleeding
in
your
stomach
or
intestines
• have serious kidney disease
• are or could be pregnant or are
breast-feeding
•
have
inflammatory
bowel
disease
If you think any of these are
relevant to you, do not take the
tablets until you have consulted
your doctor.
_ _
PREGNANCY AND BREAST-FEEDING
Pregnancy
Coxeta must not be taken during
pregnancy. If you are pregnant
or think you may be pregnant, or
if you are planning to have a
bab

Ciri produk

COXETA FC TABLETS
PRODUCT NAME
Coxeta FC tablets 60mg
Coxeta FC tablets 90mg
Coxeta FC tablets 120mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Etoricoxib 60mg
Etoricoxib 90mg
Etoricoxib 120mg
PRODUCT DESCRIPTION
60 mg: Dark green, round, biconvex film-coated tablet,
debossed “60” on one side and plain on the other.
Dimension: Approx. 8 mm diameter.
90 mg: White, round, biconvex film-coated tablet, debossed
“90” on one side and plain on the other.
Dimension: Approx. 9 mm diameter.
120 mg: Pale-green, round, biconvex film-coated tablet,
debossed “120” on one side and plain on the other.
Dimension: Approx. 10 mm diameter.
PHARMACODYNAMICS
Pharmacotherapeutic group: Anti-inflammatory and
antirheumatic products, non-steroids, coxibs, ATC code:
M01AH05
_Mechanism of Action_
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2)
inhibitor within the clinical dose range.
Etoricoxib produce dose-dependent inhibition of COX-2 without
inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did
not inhibit gastric prostaglandin synthesis and had no effect on
platelet function.
Cyclooxygenase is responsible for generation of prostaglandins.
Two isoforms, COX-1 and COX-2, have been identified. COX-2 is
the isoform of the enzyme that has been shown to be induced
by pro-inflammatory stimuli and has been postulated to be
primarily responsible for the synthesis of prostanoid mediators
of pain, inflammation, and fever. COX-2 is also involved in
ovulation, implantation and closure of the ductus arteriosus,
regulation of renal function, and central nervous system
functions (fever induction, pain perception and cognitive
function). It may also play a role in ulcer healing. COX-2 has
been identified in tissue around gastric ulcers in man but its
relevance to ulcer healing has not been established.
PHARMACOKINETICS
_Absorption_
Etoricoxib is well absorbed from the gastrointestinal tract after
oral doses.
The mean oral bioavailability is approximately 100%.
Peak plasma concentrations occur in about 1 hour in fasted
adu