Coxitor 120mg Film-coated Tablets

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

ETORICOXIB

থেকে পাওয়া:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Name):

ETORICOXIB

প্যাকেজ ইউনিট:

30tablet Tablets; 100tablet Tablets

Manufactured by:

CADILA PHARMACEUTICALS LIMITED

তথ্য লিফলেট

_Consumer Medication Information Leaflet (RiMUP)_
COXITOR 90MG & 120MG FILM-COATED TABLET
Etoricoxib 90mg & 120mg
1
WHAT IS IN THIS LEAFLET:
1.
What COXITOR is used for
2.
How COXITOR works
3.
Before you use
COXITOR
4.
How to use COXITOR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
COXITOR
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT COXITOR IS USED FOR
Coxitor helps to reduce the pain and swelling
(inflammation) in the joints and muscles of
people
with
osteoarthritis,
rheumatoid
arthritis, ankylosing spondylitis and gout.
Coxitor
is
also
used
for
the
short-term
treatment
of
moderate
pain
after
dental
surgery.
HOW COXITOR WORKS
Coxitor is one of a group of medicines called
selective COX-2 inhibitors. These belong to
a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
BEFORE YOU USE COXITOR
_When you must not use it _
DO NOT TAKE COXITOR:
-
if you are allergic to etoricoxib or any of
the other ingredients of this medicine (see
section on ingredients)
-
if you are allergic to non-steroidal anti-
inflammatory drugs (NSAIDs), including
acetylsalicylic acid and COX-2 inhibitors
(see section on side effects)
-
if you have a current stomach ulcer or
bleeding in your stomach or intestines
-
if you have serious liver disease
-
if you have serious kidney disease
-
if you are pregnant or breast-feeding
-
if you are under 16 years of age
-
if you have inflammatory bowel disease,
such
as
Crohn’s
Disease,
Ulcerative
Colitis, or Colitis
-
if
your
doctor
has
diagnosed
heart
problems including heart failure (moderate
or severe types), angina (chest pain) or if
you
have
had
a
heart
attack,
bypass
surgery, peripheral arterial disease (poor
circulation in legs or feet due to narrow or
blocked arteries), or any kind of stroke
(including mini-stroke, transient ischaemic
attack or TIA). Etoricoxib may slightly
increase your risk of heart attack and stroke
and this is why it should not be used in
those who have already had heart proble

পণ্য বৈশিষ্ট্য

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Coxitor 90 mg film-coated tablets
Coxitor 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg of etoricoxib.
Each film-coated tablet contains 120 mg of etoricoxib.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
90 mg tablets:
White round, biconvex, film-coated tablets
120 mg tablets:
Pale green, round, biconvex, film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for:
•
Acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA), rheumatoid arthritis (RA)
•
Treatment of ankylosing spondylitis (AS)
•
Treatment of acute gouty arthritis
•
Treatment of acute pain, including that related to primary
dysmenorrhoea and minor dental procedures.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual
patient's overall risks (see Precautions).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used.
The patient's need for symptomatic
relief and response to therapy should be re-evaluated periodically,
especially in patients with osteoarthritis
(see sections 4.3, 4.4, 4.8 and 5.1).
_Osteoarthritis _
The recommended dose is 30 mg once daily. In some patients with
insufficient relief from symptoms, an
increased dose of 60 mg once daily may increase efficacy. In the
absence of an increase in therapeutic
benefit, other therapeutic options should be considered.
_Rheumatoid arthritis _
The recommended dose is 60 mg once daily. In some patients with
insufficient relief from symptoms, an
increased dose of 90 mg once daily may increase efficacy. Once the
patient is clinically stabilised, down-
titration to a 60 mg once daily dose may be appropriate. In the
absence of an increase in therapeutic
benefit, other therapeutic options should be considered.
_Ankylosing spondy