TORCOXIB 200mg CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

10 Capsules; 30 Capsules; 100 Capsules

Dikeluarkan oleh:

TORRENT PHARMACEUTICAL LIMITED

Risalah maklumat

TORCOXIB CAPSULES
_ _
Celecoxib 200 mg
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is TORCOXIB used for
2.
How TORCOXIB works
3.
Before you use TORCOXIB
4.
How to use TORCOXIB
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
TORCOXIB
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TORCOXIB IS USED FOR
•
For the management of acute pain
in
adult
for
the
treatment
of
menstrual pain.
•
Relief of 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.
HOW TORCOXIB WORKS
TORCOXIB
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.
TORCOXIB
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.
BEFORE YOU USE TORCOXIB
-
_When you must not use it _
Do not take TORCOXIB unless you
have been prescribed TORCOXIB by
your doctor.
The
following
information
will
help
you
get
the
best
results
with
TORCOXIB. If you have any further
questions,
please
ask
your
doctor
or
pharmacist.
Do not take TORCOXIB:
•
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
(

Ciri produk

For the use of a Registered Medical Practitioner or Hospital or a
Laboratory only
xxxxxxxxx-5253
TORCOXIB 200 MG CAPSULES
(Celecoxib Capsules 200 mg)
PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
COUNTRY : Malaysia
NO. OF COLOURS : 1
PANTONE SHADE NOS :
LOCATION : INDRAD
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
Reviewed By
PKG. DEV
Approved By
QUALITY
PKG. DEV
ACTIVITIES
Black
Torcoxib
Insert
Front_Back
8076145-5253
150 x 510
S/S
23-09-2021
SUPERSEDES A/W NO.:
REMARK :
SUBSTRATE :
PAEDIATRIC POPULATION
Interaction studies have only been performed in adults.
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
Inhibition of prostaglandin synthesis might adversely affect
pregnancy. Data from epidemiological studies suggest an increased risk
of
spontaneous abortion after use of prostaglandin synthesis inhibitors
in early pregnancy. The potential for human risk in pregnancy is
unknown,
but cannot be excluded. Celecoxib, as with other drugs inhibiting
prostaglandin synthesis, may cause uterine inertia and premature
closure of
the ductus arteriosus during the last trimester. Celecoxib is
contraindicated in pregnancy and in women who can become pregnant. If
a woman
becomes pregnant during treatment, celecoxib should be discontinued.
BREAST-FEEDING
Administration of celecoxib to a limited number of lactating women has
shown a very low transfer of celecoxib into breast milk. Women who
take celecoxib should not breastfeed.
FERTILITY
Based on the mechanism of action, the use of NSAIDs, including
celecoxib, may delay or prevent rupture of ovarian follicles, which
has been
associated with reversible infertility in some women.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Patients who experience dizziness, vertigo or somnolence while taking
celecoxib should refrain from driving or operating machinery.
UNDESIRABLE EFFECTS
Adverse reactions are listed by system organ class and ranked by
frequency in Table 1, reflecting data from the following sources:
ADVERSE DRUG REACTION FREQUENCY SYSTEM