Avonac SR 100mg Tablet

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

Abio Marketing Sdn Bhd

INN (Nama Internasional):

DICLOFENAC SODIUM

Unit dalam paket:

100Tablet Tablets

Diproduksi oleh:

SYNMOSA BIOPHARMA CORPORATION

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AVONAC SR TABLET
Diclofenac Sodium (100mg)
1
WHAT IS IN THIS LEAFLET
1.
What Avonac is used
for
2.
How Avonac Works
3.
Before
you
use
Avonac
4.
How to use Avonac
5.
While
you
are
using
Avonac Tablets
6.
Side Effects
7.
Storage
and
disposal
of Avonac
8.
Product description
9.
Manufacturer
and
Product
registration
Holder
10.
Date of revision
WHAT AVONAC IS USED FOR
Avonac Tablets contain
diclofenac and belong to a
group of medicines called
non-steroid anti-
inflammatory drugs
(NSAIDs).
Avonac Tablets are used to
treat rheumatoid Arthritis
(
systemic inflammatory
disorder that affects joints)
&
ankylosing
spondylitis
(chronic
inflammatory
disease
of
the
skeleton)
;
osteoarthrosis
(degenerative
joint
disease)
&
spondylarthritis
(inflammation
of
the
joint)
;
non-articular
rheumatism
(musculoskeletal
aches
and
pains which do not arise from
joints)
;
painful,
post-
operative
&
post-traumatic
inflammation
&
swelling;
painful
inflammatory
conditions
in
gynecology
(medical science that deals
with the health maintenance
and
diseases
of
women,
especially
of
the
reproductive organs).
HOW AVONAC WORKS
Diclofenac
Sodium
slow
release
works
by
reducing
hormones
that
cause
inflammation
and
pain
in
the body.
BEFORE YOU USE AVONAC
_- When you must not use it _
•
You
know
that
you
are
allergic
to
Diclofenac
Sodium
or
any
of
the
ingredients in this medicine.
•
You
have
or
previously
have
had
a
peptic
ulcer
bleeding or ruptured bowel
(hole) in your stomach, or
intestines.
•
You
show
any
signs
of
allergy (such as asthma, hay
fever or skin rash) to aspirin,
ibuprofen or other NSAIDs
(anti-inflammatory medicine)
•
You
have
heart
disease,
kidney
or
liver
failure
or
bleeding in your brain
• You have had stomach or
bowel problems after taking
other NSAIDs
• You are in your last three
months of pregnancy.
_- Before you start to use it _
Be careful and check with
doctor or pharmacist if:
• You have had an ulcer or
some
other
problem
affecting your stomach, or
intestines (ulcerati

Karakteristik produk

COMPOSITION
Each film-coated tablet contains:
Diclofenac sodium
………………
100mg
DESCRIPTION
Pink to pink-orange, round, biconvex, film-coated
tablets
INDICATIONS
For rheumatoid arthritis & ankylosing spondylitis;
osteoarthrosis & spondylarthritis; non-articular
rheumatism; painful, post-operative & post-traumatic
inflammation & swelling; painful inflammatory
conditions in gynecology.
PHARMACODYNAMIC
Diclofenac sodium is a non-steroidal anti-inflammatory
agent which has analgesic and antipyretic properties.
It is a prostaglandin synthetase (cyclo-oxygenase)
inhibitor.
PHARMACOKINETICS
Following ingestion, diclofenac sodium is completely
absorbed from the intestinal tract but undergoes first
pass metabolism and peak plasma concentrations occur
in about 2 to 4 hours; at therapeutic concentrations it is
more than 99% bound to plasma proteins. Diclofenac
is almost entirely metabolized in the liver and the
terminal plasma half-life is about 1-2 hours, with
metabolic excretion mainly via the kidneys and also in
the bile.
DOSAGE AND ADMINISTRATION
For oral administration.
This is slow release tablet. It should be swallowed
whole with liquid, and must not be divided or chewed.
The recommended initial daily dosage is 100mg.
As a general recommendation, the dose should
be individually adjusted. Adverse effects may be
minimized by using the lowest effective dose for the
shortest duration necessary to control symptoms (see
section WARNINGS AND PRECAUTIONS)
ESTABLISHED CARDIOVASCULAR DISEASE OR
SIGNIFICANT CARDIOVASCULAR RISK FACTORS
Treatment with diclofenac is generally not
recommended in patients with established
cardiovascular disease (congestive heart failure,
established ischemic heart disease, peripheral arterial
disease) or uncontrolled hypertension. If needed,
patients with established cardiovascular disease,
uncontrolled hypertension, or significant risk factors
for cardiovascular disease (e.g. hypertension,
hyperlipidaemia, diabetes melilitus and smoking)
should be treated with diclofenac only after caref