CELEBIB 200 (CELECOXIB CAPSULES 200MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

3 x 10 Capsules; 10 x 10 Capsules

Dikeluarkan oleh:

Macleods Pharmaceuticals Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
CELEBIB 100/200
CELECOXIB CAPSULES 100 MG / 200 MG
Page 1 of 3
WHAT IS IN THIS LEAFLET?
1)
What Celebib 100 / 200 is used for
2)
How Celebib 100 / 200 works
3)
Before you use Celebib 100 / 200
4)
How to use Celebib 100 / 200
5)
While you are using Celebib 100 /
200
6)
Side effects
7)
Storage and Disposal of Celebib
100 / 200
8)
Product Description
9)
Manufacturer
10)
Product Registration Holder
1.
WHAT CELEBIB 100 / 200 IS USED
FOR:
Celebib 100 / 200 is used in acute pain
in
adults
and
for
the
treatment
of
primary dysmenorrhoea. Relief of acute
and chronic pain and inflammation of
rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis.
2.
HOW CELEBIB 100 / 200 WORKS:
Celecoxib belongs to a group of
medicinal products called nonsteroidal
anti-inflammatory drugs (NSAID), and
specifically a sub-group known as
(COX-2) inhibitors. Your body makes
prostaglandins that may cause pain and
inflammation.
In
conditions
such
as
rheumatoid
arthritis
and
osteoarthritis
your
body
makes more of these. Celecoxib acts by
reducing
the
production
of
prostaglandins,
thereby
reducing
the
pain and inflammation.
You
should
expect
your
medicine
to
start working within hours of taking the
first dose, but you may not experience a
full effect for several days.
3.
BEFORE YOU USE CELEBIB 100 / 200 :
-
_When you must not use it _
Tell your doctor if any of the following
are true for you as patients with these
conditions should not take Celecoxib:
•
if you are allergic to celecoxib or any
of the other ingredients of this medicine
•
if you have had an allergic reaction to
a
group
of
medicines
called
“sulphonamides” (e.g. some antibiotics
used to treat infections)
•
if you currently have an ulcer in your
stomach or intestines, or bleeding in
your stomach or intestines
•
if as a result of taking acetylsalicylic
acid or any other anti-inflammatory and
pain-relieving medicine (NSAID) you
have had asthma, nose polyps, severe
nose congestion, or an allergic reaction
such as an itch

Ciri produk

HEPATIC IMPAIRMENT: No dosage adjustment is necessary in patients with
mild hepatic
impairment (Child-Pugh Class A). Introduce celecoxib at half the
recommended dose in
arthritis or pain patients with moderate hepatic impairment
(Child-Pugh Class B).
SYMPTOMATIC TREATMENT OF RHEUMATOID ARTHRITIS (RA): The recommended
dose of
celecoxib is 100 mg or 200 mg twice per day.
CYP2C9 POOR METABOLIZERS: Patients who are known, or suspected to be
CYP2C9 poor
metabolizers based on genotyping or previous history/experience with
other CYP2C9
substrates should be administered celecoxib with caution as the risk
of dose-dependent
adverse effects is increased. Consider reducing the dose to half the
lowest recommended
dose.
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.
Adults
TREATMENT OF PRIMARY DYSMENORRHEA: 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.
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.
RENAL IMPAIRMENT: No dosage adjustment is necessary in patients with
mild or moderate
renal impairment. There is no clinical experience in patients with
severe renal impairment (see
Special Warnings and Special Precautions for Use – Renal Effects).
CHILDREN: Celecoxib is not indicated for use in children.
Patients with severe hepatic impairment (Child-Pugh Class C) have not
been studied (see
Special Warnings and Special Precautions for Use - Hepatic Effects).
LOW BACK PAIN (LBP): Usual dosage for adults is 100 mg of celecoxib
orally twice daily,
morning and evening after meal, or 200 mg once daily (100 mg and 200
mg only).
SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA):