ARCOXIA 90MG TABLET

国家: 马来西亚

语言: 英文

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

有效成分:

ETORICOXIB

可用日期:

ORGANON MALAYSIA SDN. BHD.

INN（国际名称）:

ETORICOXIB

每包单位数:

30tablet Tablets; 100tablet Tablets

厂商:

Rovi Pharma Industrial Services S.A

资料单张

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Copyright 2023 Organon group of companies. All rights reserved.
ARCOXIA
® TABLET
Etoricoxib (30 mg, 60 mg, 90 mg, 120 mg)
WHAT IS IN THIS LEAFLET
1.
What Arcoxia tablet is used for
2.
How Arcoxia tablet works
3.
Before you take Arcoxia tablet
4.
How to take Arcoxia tablet
5.
While you are taking Arcoxia
tablet
6.
Side effects
7.
Storage and Disposal of Arcoxia
tablet
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ARCOXIA TABLET IS USED FOR
Your doctor has prescribed
Arcoxia tablet for:
•
treatment of osteoarthritis
•
treatment of rheumatoid
arthritis
•
treatment of ankylosing
spondylitis
•
chronic low back pain (30
mg and 60 mg only)
•
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.
You may obtain further
information from your doctor or
pharmacist, who have more
detailed information.
HOW ARCOXIA TABLET WORKS
Arcoxia tablet is a member of a
group of medicines called
selective COX-2 inhibitors that
are used to reduce pain and
inflammation. Arcoxia tablet is
not a narcotic.
BEFORE YOU TAKE ARCOXIA TABLET
_-_
_ _
_When you must not take it _
Do not take Arcoxia tablet if you:
•
are allergic to any of its
ingredients
•
have had 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

产品特点

LPC-OG0663-T-022021-Malaysia
LOCAL PRODUCT CIRCULAR
TABLETS
ARCOXIA®
(ETORICOXIB)
I. THERAPEUTIC CLASS
ARCOXIA
®
(etoricoxib) is a member of a class of arthritis/analgesia medications
called Coxibs.
ARCOXIA is a highly selective inhibitor of cyclooxygenase-2 (COX-2).
II. COMPOSITION
IIa. Active Ingredients
Each tablet of ARCOXIA for oral administration contains either 30, 60,
90 or 120 mg
of etoricoxib.
IIb. Inactive Ingredients
Each
tablet
contains
calcium
hydrogen
phosphate
(anhydrous),
carnauba
wax,
croscarmellose
sodium,
hypromellose,
lactose
monohydrate,
magnesium
stearate,
microcrystalline cellulose, titanium dioxide, and glycerol triacetate.
The 30 mg, 60 mg and
120 mg tablets also contain yellow ferric oxide and FD&C Blue #2
(indigo carmine lake).
III. INDICATIONS
ARCOXIA is indicated for:
•
Acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA) and
rheumatoid arthritis (RA)
•
Treatment of ankylosing spondylitis (AS)
•
Treatment of acute gouty arthritis
•
Chronic low back pain (30 mg and 60 mg only)
•
Treatment of acute pain, including that related to primary
dysmenorrhoea and minor
dental procedures.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of
the individual patient's overall risks (see PRECAUTIONS).
IV. DOSAGE AND ADMINISTRATION
ARCOXIA is administered orally. ARCOXIA may be taken with or without
food. ARCOXIA
should be administered for the shortest duration possible and the
lowest effective daily
dose should be used.
Osteoarthritis
The recommended dose is 30 mg or 60 mg once daily.
Rheumatoid Arthritis
The recommended dose is 60 mg or 90 mg once daily. The minimum
effective daily dose is
60 mg once daily. In some patients, 90 mg once daily may provide
increased therapeutic
benefit.
Ankylosing Spondylitis
The recommended dose is 60 mg or 90 mg once daily. The minimum
effective daily dose
is 60 mg once daily. In some patients, 90 mg once daily may provide
increased
therapeutic benefit.
Chronic low back pain
_ _
The recommende