Zobrex Capsule 200mg

Country: Malaysia

Language: English

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

Active ingredient:

CELECOXIB

Available from:

STADPHARM SDN. BHD.

INN (International Name):

CELECOXIB

Units in package:

100 Capsules; 10 Capsules

Manufactured by:

Macrophar Co.,Ltd

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ZOBREX CAPSULE 200 MG
Celecoxib 200 mg
WHAT IS IN THE LEAFLET
1.
What Zobrex capsule 200 mg is used for
2.
How Zobrex capsule 200 mg works
3.
Before you take Zobrex capsule 200 mg
4.
How to use Zobrex capsule 200 mg
5.
While you are using Zobrex capsule 200
mg
6.
Side Effects
7.
Storage and Disposal of Zobrex capsule
200 mg
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
WHAT ZOBREX CAPSULE 200 MG IS USED FOR
Zobrex capsule 200 mg are used for the
management of acute pain, chronic pain and
inflammation in adults. It is indicated in
menstrual pain, arthritic pain, ankylosing
spondylitis (spinal arthritis) and low back
pain.
HOW ZOBREX CAPSULE 200 MG WORKS
The active ingredient in Zobrex capsule 200
mg which is Celecoxib, selectively inhibits
an enzyme called cyclooxygenase-2 (COX-
2) which is involved in the process of
inflammation in the body.
BEFORE YOU TAKE ZOBREX CAPSULE 200 MG
_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 (hypersensitive) to
celecoxib or any of the other ingredients
of this medicine (listed in section Product
Description)
•
if you have had an allergic reaction to a
group of medicines called
“sulphonamides”
•
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 (non
-
cancerous,
soft and painless growths inside the nose
or sinuses), 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
•
if you are pregnant. If you can become
pregnant during ongoing treatment you
should discuss methods of contraception
with your doctor
•
if you are breast-feeding
•
if you have

Summary of Product characteristics

PACKAGE INSERT
ZOBREX
BRAND OR PRODUCT NAME
Zobrex Capsule 200 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Celecoxib 200 mg
PRODUCT DESCRIPTION
White, No.2 hard gelatin capsule, with “ MacroPhar ” overprinted
in black colour on capsule containing white
granular powder.
PHARMACODYNAMICS/ PHARMACOKINETICS
PHARMACODYNAMICS
Pharmacotherapeutic group: Non-steroidal anti-inflammatory and
antirheumatic drugs, NSAIDs, Coxibs.
ATC code: M01AH01.
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor
within the clinical dose range (200-400 mg
daily).
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.
The difference in antiplatelet activity between some COX-1 inhibiting
NSAIDs and COX-2 selective inhibitors
may be of clinical significance in patients at risk of thrombo-embolic
reactions. COX-2 selective inhibitors
reduce the formation of systemic (and therefore possibly endothelial)
prostacyclin without affecting platelet
thromboxane.
Celecoxib is a diaryl-substituted pyrazole, chemically similar to
other non-arylamine sulfonamides (e.g.
thiazides, furosemide) but differs from arylamine sulfonamides (e.g.
sulfamethoxizole and other sulfonamide
antibiotics).
PHARMACOKINETICS
Celecoxib is well absorbed reaching peak plasma concentrations after
approximately 2-3 hours. Dosing
with food (high fat meal) delays absorption by about 1 hour.
Celecoxib is main