DICLOGESIC GEL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

ANTAH PHARMA SDN. BHD.

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

30gm mcg/mL

Dikeluarkan oleh:

DAR AL DAWA DEVELOPMENT &INVESTMENT CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DICLOGESIC
_®_
_ _GEL
Diclofenac Sodium 1% w/w
1
WHAT IS IN THIS LEAFLET
1.
What Diclogesic® Gel is used for
2.
How Diclogesic Gel works
3.
Before you use Diclogesic Gel
4.
How to use Diclogesic Gel
5.
While you are using Diclogesic
Gel
6.
Side Effects
7.
Storage and Disposal of Diclogesic
Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DICLOGESIC GEL IS USED FOR
Diclogesic Gel is used for the
external treatment of pain,
inflammation and swelling in:
-
Injuries of tendons,
ligaments, muscles and
joints, e.g. sprains, bruises,
strains, or back pain after
sport or accidents.
-
Localized forms of soft
tissue rheumatism such as
tendinitis (tennis elbow),
shoulder-hand syndrome,
bursitis, periarthropathies
and for the symptomatic
treatment of osteoarthritis of
small and medium- sized
joints located close to the
skin such as the finger joints
or knee joints.
HOW DICLOGESIC GEL WORKS
Diclogesic Gel contains the active
ingredient diclofenac, which belongs
to a group of medicines called non-
steroidal anti-rheumatic drugs
(analgesic and anti-inflammatory
medicines).
Diclogesic gel has analgesic and anti-
inflammatory properties and has a
soothing and cooling effect due to the
aqueous-alcoholic base.
BEFORE YOU USE DICLOGESIC GEL
_-_
_ _
_When you must not use it _
Diclogesic Gel should not be used in
cases of hypersensitivity to the active
substance diclofenac or other
analgesic and anti-inflammatory
agents (especially acetylsalicylic acid
/aspirin and ibuprofen) and in case of
hypersensitivity to propylene glycol,
isopropyl alcohol or other excipients.
Such hypersensitivity is expressed for
example by asthma, respiratory
problems, skin rash, urticarial,
swelling of the face and tongue,
rhinorrhea (runny nose).
Diclogesic Gel should not be used
during the 3
rd
trimester of pregnancy.
_-_
_ _
_Before you start to use it _
Diclogesic Gel should not be applied
on open wounds (e.g. abrasions, cuts)
or on damaged skin (e.g

Ciri produk

(Diclofenac Diethylamine)
PHARMACODYNAMICS:
DICLOGESIC® gel is an anti-inflammatory and analgesic preparation for
topical
application. Its active substance corresponds to 1% diclofenac sodium.
The
white, creamy, non-greasy preparation is easy to rub into the skin,
and its
aqueous-alcohol base gives it a soothing and cooling effect.
Diclofenac has
been shown in experiment to inhibit prostaglandin biosynthesis and
this is
regarded as an important factor in its mechanism of action. In
inflammation of
traumatic origin, DICLOGESIC® gel has been shown to relieve pain,
reduce
oedema, and shorten the time to return of normal function.
PHARMACOKINETICS:
ABSORPTION: The amount of diclofenac absorbed through the skin is
proportional to the contact time and skin area covered with
DICLOGESIC® gel,
and depends on the total topical dose and on skin hydration. About 6 %
of the
active substance is absorbed after topical application of 2.5 g
diclofenac gel per
500 cm2, as determined by reference to total renal elimination
compared with
diclofenac tablets. Absorption of diclofenac increases threefold if an
occlusive
dressing is applied for 10 hours.
DISTRIBUTION: Diclofenac can be detected in the plasma, synovial
tissue, and
synovial fluid after topical application of diclofenac gel to the
wrists and knees.
Peak plasma concentration of diclofenac gel are about 100 times lower
after
topical application of diclofenac gel than after oral administration
of diclofenac
tablets. 99.7% of diclofenac binds to serum proteins, mainly to
albumin (99.4%).
METABOLISM: Biotransformation of diclofenac takes place partly by
glucuronidation of the intact molecule, but mainly by single or
multiple
hydroxylation resulting in several phenolic metabolites, most of which
are
converted to glucuronide conjugates. Two of these phenolic metabolites
are
biologically active, but to a much lesser extent than diclofenac.
ELIMINATION: Total systemic clearance of diclofenac from the plasma is
263 ± 56
ml/min (mean value ± standard deviation). The terminal pla