Diclac® 150 ID modified-release tablet

Country: Malaysia

Language: English

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

Active ingredient:

DICLOFENAC SODIUM

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

DICLOFENAC SODIUM

Units in package:

100Tablet Tablets; 10Tablet Tablets; 20Tablet Tablets; 50Tablet Tablets

Manufactured by:

Salutas pharma GmbH

Patient Information leaflet

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DICLAC
®
150 ID MODIFIED RELEASE TABLET
Diclofenac Sodium (150mg)
WHAT IS IN THIS LEAFLET
1.
What Diclac
®
150 ID is used for
2.
How Diclac
®
150 ID works
3.
Before you use Diclac
®
150 ID
4.
How to use Diclac
®
150 ID
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Diclac
®
150 ID
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT DICLAC
®
150 ID IS USED FOR
Diclac
®
150 ID contains the active ingredient
diclofenac sodium.
It is indicated for the treatments of:
•
Inflammatory and degenerative forms of
rheumatism: rheumatoid arthritis (systemic
inflammatory disorder that affects joints),
Juvenile arthritis (inflammation of the joint
in children), ankylosing spondylitis (chronic
inflammatory disease of the skeleton),
osteoarthritis (degenerative joint disease),
spondylarthritis (inflammation of the joint),
painful syndromes of the vertebral column,
non-articular rheumatism (musculoskeletal
aches and pains which do not arise from
joints)
•
Acute attack of gout
•
Post-traumatic and post-operative pain,
inflammation and swelling
•
Primary dysmenorrhoea (period pain)
HOW DICLAC
®
150 ID WORKS
Diclofenac sodium belongs to a group of
medicines called non-steroidal anti-
inflammatory drug (NSAIDs). It works to
reduce pain and inflammation (swelling and
redness).
BEFORE YOU USE DICLAC
®
150 ID
-
_When you must not use it_
Do not take Diclac
®
150 ID if you:
•
Have ever had a reaction or been told that
you are allergic to diclofenac sodium or to
any of the excipients.
•
Any other similar medicines, such as
aspirin or other NSAIDs
•
Have asthma or have had a skin rash, facial
swelling or runny nose after taking other
NSAIDs
•
Had or have stomach and intestinal ulcers
or bleeding in the digestive tract (including
fresh blood in the faeces or blood in vomit)
•
Have severe heart, kidney or liver problems
•
Have blood cells disorder (anaemia) or
blood clotting defects
•
During t

Summary of Product characteristics

DIRECTIONS FOR USE
PLEASE READ CAREFULLY!
_ _
_ _
DICLAC
® 150
ID
MODIFIED RELEASE TABLETS
CONTENT
One modified-release tablet (bi-layer tablet) contains 150
mg
diclofenac
sodium:
25
mg
diclofenac
sodium,
immediate release, and 125 mg diclofenac sodium, slow
release.
DESCRIPTION
Round, bi-layer tablets, white-pink coloured, flat with facet,
plain surface.
PHARMACODYNAMICS
Pharmacotherapeutic
group:
Anti-inflammatory
and
antirheumatic
products,
non-steroids,
acetic
acid
derivatives and related substances.
ATC code: M01AB05
Mechanism of action (MoA)
Diclofenac
sodium
is
a
non-steroidal
compound
with
pronounced antirheumatic, anti-inflammatory, analgesic
and
antipyretic
properties.
Inhibition
of
prostaglandin
biosynthesis, which has been demonstrated in experiments,
is considered to be fundamental to its mechanism of action.
Prostaglandins
play
an
important
role
in
causing
inflammation, pain and fever.
Diclofenac sodium in vitro does not suppress proteoglycan
biosynthesis in cartilage at concentrations equivalent to
the concentrations reached in humans.
Pharmacodynamics (PD)
In rheumatic diseases, the anti-inflammatory and analgesic
properties
of
diclofenac
elicit
a
clinical
response
characterised by marked relief from signs and symptoms
such as pain at rest, pain on movement, morning stiffness,
and swelling of the joints, as well as by an improvement in
function.
In
post-traumatic
and
post-operative
inflammatory
conditions, diclofenac rapidly relieves both spontaneous
pain and pain on movement and reduces inflammatory
swelling and wound oedema.
Diclofenac also has beneficial effects on the symptoms of
migraine attacks.
PHARMACOKINETICS
After
oral
administration
of
the
usual
gastro-resistant
pharmaceutical forms, diclofenac is completely absorbed
after passage through the stomach. Maximum plasma
levels are achieved after 1-16 hours depending on the
duration of the gastric passage, on average after 2-3 hours.
Maximum plasma levels are achieved after 10-20 minutes
following intramuscular administration and approximat