VOLTAREN 25 SUPPOSITORY 25 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

M01AB05

Dosage:

25 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

DICLOFENAC SODIUM 25 mg

Administration route:

RECTAL

Prescription type:

Prescription Only

Manufactured by:

Delpharm Huningue S.A.S.

Authorization status:

ACTIVE

Authorization date:

1991-02-22

Patient Information leaflet

VOLTAREN


Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related 
substance. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Suppositories 
ACTIVE SUBSTANCE 
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac 
sodium). 
One suppository contains 12.5 mg, 25 mg, 50 mg, or 100 mg of
diclofenac sodium. 
ACTIVE MOIETY 
Diclofenac 
Certain dosage strengths may not be available in all countries. 
EXCIPIENTS 
Hard fat. 
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. 

  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. 

  Migraine attacks. 

  As  an  adjuvant  in  severe  painful  inflammatory  infections  of  the  ear,  nose  or  throat,  e.g. 
pharyngotonsillitis,  otitis.  In  keeping  with  general  therapeutic  principles,  the  underlying 
Novartis 

Page 2 
Country Specific Package Leaflet (Singapore)03 Sep 2013 
Voltaren suppositories 

disease  should  be  treated  with  basic  therapy,  as  appropriate.  Fever  alone  is  not  an 
indication. 
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 necessa

Summary of Product characteristics

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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
Suppositories
ACTIVE SUBSTANCE
The active substance is diclofenac sodium.
One suppository contains 12.5 mg, 25 mg, or 50 mg of diclofenac
sodium.
EXCIPIENTS
Hard fat.
Information might differ in some 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.
•
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.
•
Migraine attacks.
•
As an adjuvant in severe painful inflammatory infections of the ear,
nose or throat, e.g.,
pharyngotonsillitis, otitis. In keeping with general therapeutic
principles, the underlying
disease should be treated with basic therapy, as appropriate. Fever
alone is not an indication.
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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 usually sufficient.
The
total
daily
dose
should generally be
divided into
2 to
3
separate
doses.
To
suppress
nocturnal
pain
and morning
stiffness,
treatment
with tablets
during
the
day can
be
supplemented by the administration of a suppository at bedtime (up to
a total maximum daily
dose of 150 mg).