Zolterol SR Tablet 100mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

Duopharma Marketing Sdn. Bhd.

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

100 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

Consumer Medication Information Leaflet (RIMUP)
1
ZOLTEROL SR TABLET
Diclofenac sodium (75mg, 100mg)
What is in the leaflet
1.
What Zolterol is used for
2.
How Zolterol works
3.
Before you use Zolterol
4.
How to use Zolterol
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Zolterol
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
What Zolterol is used for
It is used to treat the symptoms
of:

Rheumatoid
arthritis,
Osteoarthritis
(painful
inflammation
of
joints
especially
in
the
feet
and
hands)

Ankylosing
spondylitis
(form of spina arthritis)

Pain
with
swelling
(back
pain,
muscle
damage
and
tendon inflammation)

Painful
periods
(dysmenorrhoea)
How Zolterol works
Diclofenac belongs to a group
of
medicines
called
non-
steroidal
anti-inflammatory
drugs
(NSAIDs).
It
also
has
analgesic
(painkilling)
and
antipyretic
(fever
reducing)
properties.
Diclofenac
acts
by
reducing
pain (at rest and on movement),
morning stiffness and swelling
of
the
joints
associated
with
rheumatic diseases, as well as
improving function
Before you use Zolterol
-
When you must not take it
Do not take this medicine if
you
have
had
an
allergic
reaction to:

Diclofenac

aspirin
or
any
other
NSAIDs

Any
of
the
ingredients
listed
at
the
end
of
this
leaflet.
Symptoms
of
an
allergic
reaction may include: shortness
of
breath,
wheezing
or
difficulty
breathing;
swelling
of the face, lips, tongue, throat
or
other
parts
of
the
body;
muscle pain or tenderness or
joint pain or rash, itching or
hives on the skin.
Zolterol
is
not
recommended
for children.
Zolterol should be used with
caution in elderlies as they are
susceptible
to
side
effects
of
diclofenac sodium.
Do not take
this
medicine if
you suffer from a stomach or
duodenal ulcer and/or bleeding
from the stomach or bowel.
Do not take
this
medicine if
you suffer from severe heart,
liver or kidney problems.
Do not take
this
medicine if
you are pregnant.
Diclofenac
may
affect
your
developing
baby,
and
may
delay labour and

Ciri produk

PRODUCT DESCRIPTION
Zolterol SR Tablet 100mg are pale pink, round, film coated tablet,
plain on both sides.
Zolterol SR Tablet 75mg are pale pink, triangular tablet, film coated
tablet, plain on both sides.
COMPOSITION
Zolterol SR Tablet 100mg - active ingredient: Diclofenac sodium 100mg.
Zolterol SR Tablet 75mg - active ingredient: Diclofenac sodium 75mg.
PHARMACODYNAMICS
Prostaglandins are known to contribute significantly in the
pathogenesis of inflammation, pain
and fever. The formation of precursors of prostaglandins and
thromboxanes from arachidonic
acid is reduced in the presence of diclofenac, it inhibits the
activity of the enzyme
cyclo-oxygenase.
As an antirheumatic and anti-inflammatory drug, diclofenac may act
peripherally in inflamed
tissues and block pain impulse generation possibly by reducing
prostaglandin activities and
inhibition of synthesis and actions of the local mediators involved in
such responses.
Diclofenac also works as an antipyretic by acting centrally on the
hypothalamic heat-regulating
centre to increase peripheral vasodilation which then increases blood
flow through the skin,
sweating and heat loss. This central action in the hypothalamus may be
due to the reduction of
prostaglandin activity.
PHARMACOKINETICS
Diclofenac is almost completely absorbed from the SR tablet. The peak
plasma concentration
of Zolterol SR tablet is lower than the conventional tablet as it is
released more slowly. Absorp-
tion of Zolterol SR tablet is slower when taken with or after meal
than when taken in an empty
stomach. However, the amount of diclofenac absorbed is not affected by
food.
No accumulation in plasma happens after repeated oral administration
if the recommended
dosage intervals are adhered to. More than 99% of diclofenac is bound
to plasma proteins at
therapeutic level. Diclofenac also penetrates synovial fluid where its
concentration might persist
even when plasma concentrations fall.
Only about 50% of diclofenac reaches the systemic circulation in the
unchanged form due to
first-pass metabo