VOLTAREN 50 TABLET 50 mg

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

DICLOFENAC SODIUM

から入手可能:

NOVARTIS (SINGAPORE) PTE LTD

ATCコード:

M01AB05

投薬量:

50 mg

医薬品形態:

ENTERIC COATED TABLET

構図:

DICLOFENAC SODIUM 50 mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

Novartis Saglik, Gida ve Tarim Ürünleri San. Ve Tic. A.S.

認証ステータス:

ACTIVE

承認日:

1991-04-08

情報リーフレット

VOLTAREN


Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related 
substance. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Gastro-resistant tablets. 
ACTIVE SUBSTANCE 
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac 
sodium). 
One gastro-resistant tablet contains 25 mg or 50 mg of
diclofenac sodium. 
ACTIVE MOIETY 
Diclofenac 
Certain dosage strengths may not be available in all countries. 
EXCIPIENTS 
CORE FOR 25 MG AND 50 MG: colloidal anhydrous silica, lactose, maize starch, sodium starch 
glycollate, povidone, microcrystalline cellulose,
magnesium stearate. 
COATING FOR 25 MG: hypromellose, yellow iron oxide (E 172), purified talc, titanium dioxide 
(E 171), methacrylic acid copolymer, polyethylene glycol 8000, simeticone, polyoxyethylene 
40 hydrogenated castor oil. 
COATING FOR 50 MG: hypromellose, yellow iron oxide (E 172), purified talc, titanium dioxide 
(E 171), methacrylic acid copolymer, polyethylene glycol 8000, simeticone, red iron oxide (E 
172), polyoxyethylene 40 hydrogenated castor oil. 
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. 
Novartis 

Page 2 
Country Specific Package Leaflet (Singapore)03 Sep 2013 
Voltaren  gastro-resistant tablets 


  Painful  and/or  inflammatory  conditions  in  gynaecology,  e.g.  primary  dysmenorrhoea�

製品の特徴

Voltaren 50mg Tablet 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
Gastro-resistant tablets.
ACTIVE SUBSTANCE
The active substance is diclofenac sodium.
One gastro-resistant tablet contains 50 mg of diclofenac sodium.
EXCIPIENTS
CORE FOR 50 MG:
colloidal anhydrous silica, lactose, maize starch, sodium starch
glycollate,
povidone, microcrystalline cellulose, magnesium stearate.
COATING FOR 50 MG:
hypromellose, yellow iron oxide (E 172), purified talc, titanium
dioxide
(E
171), methacrylic acid copolymer, polyethylene glycol 8000,
simeticone, red iron oxide (E 172),
polyoxyethylene 40 hydrogenated castor oil.
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.
•
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