VOLTAREN SR 100 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

100Tablet Tablets; 30Tablet Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
VOLTAREN
® SLOW RELEASE TABLET
Diclofenac Sodium (75mg, 100mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT VOLTAREN IS USED FOR
2.
HOW VOLTAREN WORKS
3.
BEFORE YOU USE VOLTAREN
4.
HOW TO USE VOLTAREN
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
VOLTAREN
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT VOLTAREN IS USED FOR
Voltaren belongs to a group of
medicines called “non-steroidal
anti-inflammatory drugs”
(NSAIDs), which are used to treat
pain and inflammation as listed
below.
_Indicated for treatment of _
:

Inflammatory and degenerative
forms of rheumatism: rheumatoid
arthritis (systemic inflammatory
disorder that affects joints),
ankylosing spondylitis (chronic
inflammatory disease of the
skeleton), osteoarthritis
(degenerative joint disease) and
spondylarthritis (inflammation of
the joint), painful syndromes of
the vertebral column, non-articular
rheumatism (musculoskeletal
aches and pains which do not arise
from joints).

Post-traumatic and post-operative
pain, inflammation and swelling.

Primary dysmenorrhea (period
pain)
HOW VOLTAREN WORKS
Voltaren relieves the symptoms of
inflammation, such as pain and
swelling, by blocking the synthesis
of the molecules (prostaglandins)
responsible for inflammation, pain
and fever. It has no
effect on the
causes of inflammation or fever.
BEFORE YOU USE VOLTAREN
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in
this leaflet.
-
_When you must not use it _

If you are allergic
(hypersensitive) to diclofenac
or to any of the other
ingredients of Voltaren listed
at the end of this leaflet.

If you have
ever had an
allergic reaction after taking
medicines to treat
inflammation or pain (e.g.
acetylsalicylic acid/aspirin,
diclofenac or ibuprofen).
Reactions may include asthma,
runny nose, skin rash, swelling
of the face, lips, tongue,
throat, and/or extremities
(signs of angioedema). If y

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
04-Aug-2021
Voltaren prolonged-release tablets
VOLTAREN

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets.
ACTIVE SUBSTANCE
The active substance is diclofenac sodium.
One prolonged-release tablet contains 75 mg or 100 mg of diclofenac
sodium.
DESCRIPTION
Voltaren SR 75mg Tablets: Pale pink, triangular tablet with slightly
convex faces and bevelled
edges. Debossing of ‘ID’ on the first side and ‘CG’ on the
second side.
Voltaren SR 100mg Tablets: Pink, round tablet with slightly convex
faces with bevelled edges.
Debossing of ‘CGC’ on the first side and ‘CG’ on the second
side.
ACTIVE MOIETY
Diclofenac
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
TABLET CORE FOR 75 MG AND 100 MG:
Cetyl alcohol; magnesium stearate; povidone; silica;
colloidal anhydrous; sucrose;
TABLET COATING FOR 75 MG AND 100 MG:
hypromellose; iron oxide red (E172); macrogol 8000;
polysorbate 80; sucrose; talc; titanium dioxide (E171)
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of:

Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing
spondylitis, osteoarthritis and spondylarthritis, painful syndromes of
the vertebral column,
non-articular rheumatism.

Painful post-traumatic and post-operative inflammation and swelling.

Primary dysmenorrhoea.
Novartis
Page 3
Malaysia Package Leaflet
04-Aug-2021
Voltaren prolonged-release tablets
DOSAGE AND ADMINISTRATION
DOSAGE
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).
GENERAL TARGET POPULATION: ADULTS
The recommended initial daily dose is 100 to 150 mg, administered as 1
tablet of Voltaren
prolonged-released 100 mg or as 2 tablets of Voltaren
prolonged-released 7