Geloxib-200 (Celecoxib 200mg Capsules)

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

CELECOXIB

থেকে পাওয়া:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

CELECOXIB

প্যাকেজ ইউনিট:

3 x 10capsule Capsules; 10x10 Capsules

Manufactured by:

GRACURE PHARMACEUTICALS LTD.

তথ্য লিফলেট

_Consumer Medication Information Leaflet (RiMUP) _
GELOXIB-200 (CELECOXIB 200MG CAPSULES)
Celecoxib (200mg)
1
WHAT IS IN THIS LEAFLET
1.
What GELOXIB-200 is used for
2.
How GELOXIB-200 works
3.
Before you use GELOXIB-200
4.
How to use GELOXIB-200
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GELOXIB-200
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS GELOXIB-200 USED FOR
GELOXIB-200 is used for the
management of acute pain, chronic
pain and inflammation in adults. It is
indicated in menstrual pain, arthritic
pain, ankylosing spondylitis and
lower back pain.
HOW GELOXIB-200 WORKS
The active ingredient in GELOXIB-
200 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 USE GELOXIB-200
-When you must not use it
Do not take GELOXIB-200 if you
are pregnant, trying to get pregnant
or think you may be pregnant.
Breastfeeding mothers should not
take this medication too. Please ask
your doctor or pharmacist for advice
before taking this medicine.
You must not use GELOXIB-200 if
you are at known risk of heart
disease such as a stroke or ischemic
heart disease.
Do not use GELOXIB-200 if you
have experienced asthma, itching of
skin or other allergic type reactions
after taking other painkillers such as
aspirin or medicines in the group of
Non-Steroidal Anti Inflammatory
Drugs (NSAIDs).
-Before you start to use it
Tell your doctor if any of the
following are true for you, as patients
with these conditions should not take
GELOXIB-200
•
If you are allergic to
Celecoxib or any other
ingredients in this medicine.
•
If you are allergic to a group
of medicines called
‘sulphonamides’
•
If you currently have an
ulcer in your digestive tract
or bleeding in your
digestive tract
•
If you are allergic to a group
of drugs called NSAIDs
(Non-Steroidal Anti-
Inflammatory Drugs)
•
If you have severe liver
disease
•
If you have sever

পণ্য বৈশিষ্ট্য

WARNING
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can
occur at any time, with or without warning
symptoms. in patients treated with NSAID therapy. Although minor upper
GI problems (e.g. dyspepsia) are
common, usually developing early in therapy, prescribers should remain
alert for ulceration and bleeding in
patients treated with NSAIDs even in the absence of previous GI tract
symptoms.
Studies to date have not identified any subset of puberty not at risk
of developing peptic ulceration and bleeding.
Patients with prior history of serious GI events and other risk
factors associated with peptic ulcer disease
(e.g. alcoholism, smoking, and corticosteroid therapy) are at
increased risk. Elderly or debilitated patients seem
to tolerate ulceration or bleeding less than other individuals and
account for most spontaneous reports for fatal
GI events.
For the use only of a registered Medical Practitioner or a Hospital or
a Laboratory
GELOXIB-200
(Celecoxib Capsules 200 mg)
COMPOSITION:
Each capsule contains:
Celecoxib BP 200 mg
DESCRIPTION:
Geloxib-200 is Dark Green/Dark Green coloured hard gelatin capsule
shell of size “2”, containing white
granular powder.
PHARMACODYNAMICS / PHARMACOKINETICS:
_PHARMACODYNAMIC EFFECTS:_
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
ductusarteriosus, 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 dif