Revcox 200mg Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

100capsule Capsules; 30capsule Capsules

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
REVCOX 100MG & 200MG CAPSULE
Celecoxib 100mg & 200mg
1
WHAT IS IN THIS LEAFLET:
1.
What Revcox is used for
2.
How Revcox works
3.
Before you use Revcox
4.
How to use Revcox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Revcox
8.
Product Description
9.
Manufacturer and
Product
Registration
Holder
10.
Date of Revision
WHAT REVCOX IS USED FOR
Celecoxib
is
used
for
pain
relief
and
to
alleviate swelling of tissue in the degenerative
joint
disease
(osteoarthritis),
inflammatory
rheumatic joint disease (rheumatoid arthritis)
and
in
certain
types
of
inflammation
of
intervertebral joints (ankylosing spondylitis).
HOW REVCOX WORKS
Revcox belongs to a group of medicines called
cyclo-oxygenase-2 (COX-2) inhibitors. These
work
by
lowering
the
amount
of
prostaglandins. Prostaglandins are substances
made
by
your
body.
Some
prostaglandins
cause
pain
and
swelling,
but
others
help
protect the stomach lining. Revcox reduces the
production of prostaglandins that cause pain
and swelling and not the ones that protect the
stomach.
BEFORE YOU USE REVCOX
_When you must not use it_
•
are allergic to celecoxib or any of the other
ingredients of this medicine
•
have had an allergic reaction to a group of
medicines
called
“su
lphonamides”
(e.g.
some antibiotics used to treat infections)
•
have currently stomach or duodenal ulcer
or bleeding in the stomach or intestine
•
have had asthma, nose polyps, severe nose
congestion, or an allergic reaction such as
an itchy skin rash, swelling of the face, lips,
tongue or throat, breathing difficulties or
wheezing
as
a
result
of
taking
acetylsalicylic
acid
or
any
other
anti-
inflammatory and pain relieving medicine
(NSAID, e.g. ibuprofen, including cyclo-
oxygenase-2 (COX-2) inhibitors)
•
have severe liver disease
•
have severe kidney disease
•
are breast-feeding
•
have
an
inflammatory
disease
of
the
intestines,
such
as
ulcerative
colitis
or
Crohn’s disease
•
are pregnant or are in your fertile period (if
i

Ciri produk

Page 1 of 8
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Revcox 100 mg Capsule
Revcox 200 mg Capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REVCOX 100 MG CAPSULE
Each capsule contains 100 mg celecoxib.
Excipient(s) with known effect: lactose monohydrate.
REVCOX 200 MG CAPSULE
Each capsule contains 200 mg celecoxib.
Excipient(s) with known effect: lactose monohydrate.
3.
PHARMACEUTICAL FORM
Capsule, hard.
REVCOX 100 MG CAPSULE
Capsule: white body and blue cap, containing white to slightly yellow
coloured pellets.
REVCOX 200 MG CAPSULE
Capsule: white body and orange cap, containing white to slightly
yellow coloured pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of acute pain in adults and for the treatment of primary
dysmenorrhoea.
Relief of the acute and chronic pain and inflammation of rheumatoid
arthritis and osteoarthritis.
Relief of signs and symptoms of ankylosing spondylitis.
For the management of low back pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Celecoxib capsules can be taken with or without food.
Given the association between cardiovascular risk and exposure to
COX-2 inhibitors, doctors are advised to use the
lowest effective dose for the shortest possible duration of treatment.
ADULTS
Symptomatic Treatment of Osteoarthritis (OA): The recommended dose of
celecoxib is 200 mg administered as a
single dose or as 100 mg twice per day.
Symptomatic Treatment of Rheumatoid Arthritis (RA): The recommended
dose of celecoxib is 100 mg or 200 mg
twice per day.
Ankylosing Spondylitis (AS): The recommended dose of celecoxib is 200
mg administered as a single dose or 100
mg twice per day. Some patients may benefit from a total daily dose of
400 mg.
Management of Acute Pain: The recommended dose of celecoxib is 400 mg,
initially, followed by an additional 200
mg dose, if needed on the first day. On subsequent days, the
recommended dose is 200 mg twice daily, as needed.
Treatment of Primary Dysmenorrhea: The recommended dose of celecoxib
is 400 mg, initially, followed by an
additio