Diclac retard 100mg Tab

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:

20Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets

Manufactured by:

Salutas pharma GmbH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
DICLAC
®
RETARD TABLET
Diclofenac sodium (100mg)
WHAT IS IN THIS LEAFLET
1.
What
DICLAC
®
RETARD TABLET
is used for
2.
How
DICLAC
®
RETARD TABLET
works
3.
Before you use
DICLAC
®
RETARD TABLET
4.
How to use
DICLAC
®
RETARD TABLET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DICLAC
®
RETARD
TABLET
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT DICLAC
®
RETARD TABLET IS USED FOR
DICLAC
®
RETARD TABLET
is used for
intense
pain with:
1. Rheumatism
(joint/tissue
disease)
that causes forms of inflammation and
degeneration (e.g. rheumatoid arthritis,
ankylosing spondylitis (Bechterew’s
disease),
osteoarthritis
(degenerative
joint
disease), and spondylarthritis (inflammation
of
the
joint),
painful
conditions
in
the
vertebral column
(spine) and non-articular
rheumatism
(musculoskeletal
aches
and
pains which do not arise from joints)
2. Pain, inflammation and swelling due to
trauma and /or operations.
3. Menstrual pain
HOW DICLAC
®
RETARD TABLET WORKS
DICLAC
®
RETARD TABLET
contains the active
ingredient diclofenac sodium.
It belongs to the group of medicines called
non-steroidal
anti-inflammatory
drug
(NSAIDs).
It works to reduce pain and
inflammation (swelling and redness).
BEFORE YOU USE DICLAC
®
RETARD TABLET
_-_
_ _
_WHEN YOU MUST NOT USE IT_
Do not take this medicine if you have an
allergy to:
• diclofenac sodium, the active ingredient
• any of the other ingredients listed at the end
of this leaflet
• any other similar medicines, such as aspirin
or other NSAIDS
Do not take
DICLAC
®
RETARD TABLET
if:
• you
have
had
asthma,
rhinitis
(inflammation
of
the
nasal
mucous
membrane), urticaria (itching or hives) and
the symptoms become worsen caused by
Aspirin or NSAIDs.
• you have stomach and intestinal ulcers
• you have blood cells disorder
• you have severe heart, kidney or liver
problems
• you are children or adolescents
_-_
_ _
_BEFORE YOU START TO USE IT_
Tell your d

Summary of Product characteristics

DIRECTIONS FOR USE
PLEASE READ CAREFULLY!
_ _
_ _
DICLAC
® RETARD 100MG TABLET
MODIFIED RELEASE TABLETS
COMPOSITION
One modified-release tablet contains 100mg diclofenac
sodium;
lactose
monohydrate;
methylhydroxypropylcellulose; magnesium stearate.
PRODUCT DESCRIPTION White, round
and biconvex tablets.
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
Absorption
Judged by urinary recovery of unchanged diclofenac and
its
hydroxylated
metabolites,
the
same
amount
of
diclofenac
is
released
and
absorbed
from
diclofenac
prolonged-release tablets as from gastro-resistant tablets.
However,
the
systemic
availability
of
diclofenac
from
diclofenac prolonged-release tablets is on average about
82% of that achieved with the same dose of diclofenac
administered
in
the
form
of
gastro-resistant
ta