VOLTAREN TABLET 50MG

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

DICLOFENAC SODIUM

Доступна з:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

DICLOFENAC SODIUM

Одиниць в упаковці:

100Tablet Tablets

Виробник:

NOVARTIS SAGLIK

інформаційний буклет

_Consumer Medication Information Leaflet (RiMUP) _
VOLTAREN
® TABLET
Diclofenac Sodium (50 mg)
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
VOLTAREN
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
VOLTAREN
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
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),
juvenile
rheumatoid
arthritis,
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).

Acute attacks of gout.

Post-traumatic
and
post-
operative pain, inflammation and
swelling.

Primary dysmenorrhoea (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
your
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,
diclofenac
or
ibuprofen.
Reactions may include asthma,
runny nose, skin rash, swelling
of the face, lips, tongu

Характеристики продукта

Novartis
Page 2
Malaysia Package Leaflet
08-Sep-2022
Voltaren gastro-resistant tablets
VOLTAREN

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Gastro-resistant tablets.
ACTIVE SUBSTANCE
The active substance is diclofenac sodium.
One gastro-resistant tablet contains 50 mg of diclofenac sodium.
DESCRIPTION
Light brown round tablet with slightly convex faces and bevelled edges
with debossed “GT”
on the first side and “CG” on the second side.
ACTIVE MOIETY
Diclofenac
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
CORE:
Cellulose microcrystalline; lactose monohydrate; magnesium stearate;
maize starch;
povidone; silica, colloidal anhydrous; sodium starch glycolate (type
A).
COATING:
hypromellose; iron oxide red (E172); iron oxide yellow (E172);
macrogoglycerol
hydroxystearate; Methacrylic acid – ethyl acrylate copolymer;
macrogol 8000; talc; titanium
dioxide (E171); Simeticone;
alpha-octadecyl-omega-hydroxy-polyglykolether; sorbic acid.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of:

Inflammatory
and
degenerative
forms
of
rheumatism:
rheumatoid
arthritis,
juvenile
rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and
spondylarthritis, painful
syndromes of the vertebral column, non-articular rheumatism.

Acute attacks of gout.

Painful post-traumatic and post-operative inflammation and swelling.

Primary dysmenorrhoea.
Novartis
Page 3
Malaysia Package Leaflet
08-Sep-2022
Voltaren gastro-resistant tablets
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
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. In milder cases,
as well as for long-term
therapy, 75 to 100 mg daily is