Avegesic Tablet 7.5mg

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
16-12-2022
Ciri produk Ciri produk (SPC)
01-12-2022

Bahan aktif:

MELOXICAM

Boleh didapati daripada:

APEX PHARMACY MARKETING SDN. BHD.

INN (Nama Antarabangsa):

MELOXICAM

Unit dalam pakej:

50Tablet Tablets

Dikeluarkan oleh:

DELORBIS PHARMACEUTICALS LTD.

Risalah maklumat

                                AVEGESIC TABLET Meloxicam (7.5mg, 15mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Avegesic Tablet is used for
2.
How Avegesic Tablet works
3.
Before you use Avegesic Table
4.
How to use Avegesic Tablet
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Avegesic
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT AVEGESIC TABLET IS USED FOR
Avegesic Tablet is used for:

Symptomatic
treatment
of
painful
osteoarthritis
(degenerative
joint
disease).

Symptomatic treatment of rheumatoid
arthritis
(systemic
inflammatory
disorder that affects joints).

Symptomatic treatment of ankylosing
spondylitis
(chronic
inflammatory
disease of the skeleton).
HOW AVEGESIC TABLET WORKS
Avegesic
Tablet
contains
a
substance
called meloxicam. It belongs to a group
of
medicines
called
nonsteroidal
anti-
inflammatory drugs (NSAIDs) which are
used to reduce inflammation, pain and
fever.
BEFORE YOU USE AVEGESIC TABLET
-
_When you must not use it _

You
are
pregnant,
planning
to
become
pregnant
or
if
you
are
breast feeding.

You are allergic to meloxicam or to
any of the other ingredients listed.

You are allergic to aspirin or other
anti-inflammatory medicines.

You
have
ever
suffered
from
wheezing,
nasal
polyps
(nasal
obstruction due to swellings in the
lining in your nose) along with a
runny nose, swelling of the skin,
urticaria (nettle rash) when taking
aspirin or other anti-inflammatory
medicines.

You
have
or
have
ever
had
a
gastrointestinal
ulcer
or
perforation (ulcer of the stomach
or intestines).

You have any
kind of bleeding
disorder or have ever suffered from
gastrointestinal bleeding (bleeding
in the stomach or intestines) or
cerebrovascular
bleeding
(bleeding in the brain).

You have serious liver disease.

You have serious kidney disease
and are not undergoing dialysis.

You have severe heart failure.
-
_Before you start to take it _
Inform your doctor if:

You
                                
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Ciri produk

                                COMPOSITION
:
AVEGESIC TABLET 7.5MG
: Meloxicam 7.5 mg/ tablet
AVEGESIC TABLET 15MG
: Meloxicam 15 mg/ tablet
PRODUCT DESCRIPTION
AVEGESIC TABLET 7.5MG
: Light
yellow, round, flat tablet,
8mm diameter, cross- scored on one side.
AVEGESIC TABLET 15MG
: Light yellow, round,
concave
tablet, 10mm
diameter, scored on one side.
PHARMACODYNAMICS
Non- steroidal anti- inflammatory agent (M; locomotor
system).
Meloxicam is a non- steroidal anti- inflammatory drug
(NSAID)
of
the
oxicam
family,
with
anti-
inflammatory, analgesic and antipyretic properties.
The anti- inflammatory
activity of meloxicam has been
proven in classical models of inflammation. As with
other NSAIDs, its precise mechanism of action
remains unknown. However there is at least one
common mode of action shared by all NSAIDs
(including meloxicam):
inhibition of the
biosynthesis
of prostaglandins, known inflammation mediators.
PHARMACOKINETICS
The bioavailability of meloxicam
following oral
administration is on the average 89%.
With
the
doses
of
7.5
and
15
mg,
plasma
concentrations are proportional to dose: 0.4 to 1.0 mg/lt
for 7.5 mg and 0.8 to 2.0 mg/lt for 15 mg, on
average
(Cmin and Cmax at steady state).
Meloxicam is very
strongly bound to plasma
proteins,
essentially albumin (99%).
Meloxicam is extensively metabolized, chiefly by
oxidation of the methyl radical attached to the thiazolyl
ring. Elimination is
unchanged form accounts for 3%
of the dose. Half of the
substance is
eliminated in urine
and the other half in faeces.
The mean elimination half-life of the order of 20 hours.
Steady state is reached in 5 days.
In terminal renal failure, the
volume of distribution is
increased and a daily dose of 7.5 mg must not be
exceeded.
Plasma clearance is on average 8 ml/min. Clearance is
decreased in the
elderly. Volume of distribution is low,
on average 11
litres. Inter
individual variation is the
order of 30 – 40%.
INDICATION
- symptomatic treatment of painful
osteoarthritis (
-
arthrosis, degenerative joint disease).
- symptomatic treatment of rheumatoi
                                
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