国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
DICLOFENAC SODIUM
NOVARTIS (SINGAPORE) PTE LTD
M01AB05
25 mg
ENTERIC COATED TABLET
ORAL
Prescription Only
NOVARTIS FARMA S P A
1991-04-08
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 阅读完整的文件