Melocam Tablet 7.5mg

Country: Malaysia

Language: English

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

Active ingredient:

MELOXICAM

Available from:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (International Name):

MELOXICAM

Units in package:

500Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets; 1000 Tablets; 500 Tablets

Manufactured by:

Y.S.P. INDUSTRIES (M) SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1 |
MELOCAM TABLET
Meloxicam (7.5mg)
WHAT IS IN THIS LEAFLET
1.
What MELOCAM TABLET is used
for
2.
How MELOCAM TABLET works
3.
Before
you
use
MELOCAM
TABLET
4.
How to use MELOCAM TABLET
5.
While
you
are
using
MELOCAM
TABLET
6.
Side effects
7.
Storage and disposal of MELOCAM
TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MELOCAM TABLET IS USED FOR
MELOCAM TABLET is used for relief of
pain
and
inflammation
in
rheumatic
disease;
exacerbation
of
osteoarthritis
(arthrosis, degenerative joint disease) and
ankylosing
spondylitis
(chronic
inflammatory diseases of the skeleton).
HOW MELOCAM TABLET WORKS
Meloxicam
is
in
a
class
of
medications
called NSAIDs. It works by stopping the
body's production of a substance that causes
pain, fever, and inflammation.
BEFORE YOU USE MELOCAM TABLET
_-When you must not use it _
Do not use MELOCAM TABLET:
-
if
you
have
had
asthma,
angioedema
(swelling of your skin), urticarial (itching
or hives), nasal polyps and the symptoms
become
worsen
caused
by
Aspirin
or
NSAIDs.
- if you have active stomach ulceration.
-
if
you
have
severe
liver
or
kidney
problem.
- if you are hypersensitivity to NSAIDs.
- if you are under 15 years old.
- if you are pregnant or breastfeeding.
_-Before you start to use it _
Please consult with your doctor:
-
if
you
have
ulceration,
bleeding
or
perforation of your stomach or intestinal
- if you are elderly
- if you have kidney or liver diseases
- if you are dehydrated
- if you have heart failure or heart disease
-
if
you
need
to
undergo
major
surgical
procedures
which
lead
to
hypovolaemia
(decreased volume of circulating blood in
the body)
-
if
you
are
suffering
from
dyspepsia
(discomfort at the epigastric region due to
digestion problem).
Meloxicam may cause severe skin reactions,
e.g. exfoliative dermatitis, toxic epidermal
necrolysis,
Steven-Johnson
Syndrome.
Symptoms may include skin rash, blisters
and
peel
off.
These
could be
signs of
a
serious condition. I

Summary of Product characteristics

ATTACHMENT 1
204406-03 260X110
MELOCAM
TABLET 7.5MG
INGREDIENT(S):
Each tablet contains:
Meloxicam
…………...........................................................………........…..
7.5mg
PHARMACOLOGY:
PHARMACODYNAMICS:
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the
enolic acid
class that has shown anti-inflammatory, analgesic and antipyretic
properties in
animals. Meloxicam inhibits biosynthesis of prostaglandins, the known
mediators
of inflammation. Comparison of the ulcerogenic dose and the
anti-inflammatory
effective dose in the rat adjuvant arthritis confirmed a superior
therapeutic margin
in animals over standard NSAIDs. The selective inhibition of COX-2
relative to
COX-1 by Meloxicam has been demonstrated _ in vitro_ on various cell
systems.
Clinical studies demonstrated a lower incidence of gastrointestinal
adverse events
with the recommended doses of Meloxicam than standard doses of other
NSAIDs.
PHARMACOKINETICS:
Meloxicam is well absorbed following oral administration (89%). The
absorption is
not affected by concomitant food intake. Steady-state conditions are
achieved in 3-
5 days. In plasma, >99% is bound to plasma proteins. Once-daily dosing
leads to
drug plasma concentrations with a relatively small peak-trough
fluctuation in the
range
of
0.4-1
mcg/mL
for
7.5mg
doses
(C
min
and
C
max
at
steady
state,
respectively).
Meloxicam penetrates well into synovial fluid to give concentrations
approximately
1/2 those in plasma.
Meloxicam is extensively metabolized and <5% of the daily dose is
excreted
unchanged in faeces, while only traces of the unchanged compound are
excreted
in the urine. The mean elimination half-life of Meloxicam is 20 hours.
Neither
hepatic,
mild
or
moderate
renal
insufficiency
do
substantially
affect
meloxicam pharmacokinetics.
Plasma clearance is on average 8mL/min. Clearance is decreased in the
elderly.
Volume of distribution is low, on average 11L.
INDICATION(S):
Pain
and
inflammation
in
rheumatic
disease;
exacerbation
of
osteoarthritis
(arthrosis, dege