VOLTAREN SR 75 TABLET 75 mg

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

DICLOFENAC SODIUM

Mevcut itibaren:

NOVARTIS (SINGAPORE) PTE LTD

ATC kodu:

M01AB05

Doz:

75 mg

Farmasötik formu:

TABLET, FILM COATED

Kompozisyon:

DICLOFENAC SODIUM 75 mg

Uygulama yolu:

ORAL

Reçete türü:

Prescription Only

Tarafından üretildi:

NOVARTIS FARMA S P A

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

1993-02-11

Bilgilendirme broşürü

VOLTAREN


Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related 
substance. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Film-coated tablets.  
ACTIVE SUBSTANCE 
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac 
sodium). 
One prolonged-release tablet contains 75 mg or 100 mg of
diclofenac sodium. 
ACTIVE MOIETY 
Diclofenac 
Certain dosage strengths may not be available in all countries. 
EXCIPIENTS 
TABLET  CORE:  Sucrose;  cetyl  alcohol;  povidone;  magnesium  stearate;  silica  colloidal 
anhydrous.  
TABLET  COATING:  Hypromellose;  purified  talc;  polysorbate  80;  titanium  dioxide  (E171);  red 
iron oxide (E 172).  
POLISHING SOLUTION: Sucrose; polyethylene glycol 8000.  
Printing ink: Black (Opacode S-1-8015).  
Shellac; medicinal charcoal.  
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.  


Post-traumatic  and  post-operative  pain,  inflammation,  and  swelling,  e.g.  following 
dental or orthopaedic surgery.  
Novartis 

Page 2 
Country Specific Package Leaflet (Singapore)03 Sep 2013 
Voltaren  prolonged-release tablets 



Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or 
adnexitis.  
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). 
ADULTS�

Ürün özellikleri

Voltaren SR Sep 2022.SIN
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TRADE-NAME(S)
VOLTAREN

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative and related
substance.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets.
ACTIVE SUBSTANCE
The active substance diclofenac sodium.
One prolonged-release tablet contains 75 mg or 100 mg of diclofenac
sodium.
EXCIPIENTS
TABLET CORE:
Sucrose; cetyl alcohol; povidone; magnesium stearate; silica colloidal
anhydrous.
TABLET COATING:
Hypromellose; talc; polysorbate 80; titanium dioxide (E171); red
iron oxide
(E 172).
POLISHING SOLUTION:
Sucrose; polyethylene glycol 8000.
Printing ink: Black (Opacode S-1-
17823).
Information might differ in some 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.
•
Post-traumatic and post-operative pain, inflammation, and swelling,
e.g., following dental
or orthopaedic surgery.
•
Painful and/or inflammatory conditions in gynaecology, e.g., primary
dysmenorrhoea or
adnexitis.
Voltaren SR Sep 2022.SIN
Page
2
of
14
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, administered as 1
tablet of Voltaren
prolonged-released 100 mg or as 2 tablets of Voltaren
prolonged-released 75 mg.
In milder cases, as well as for long-term therapy, 75 to 100 mg daily
is usually sufficient.
Where the symptoms are most pronounced during the night or in the
morning, Voltaren
prolonged-release 75 mg and 100 mg should preferably be taken in the
evening.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
Voltaren is contraindicated in patients with renal failure