Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
DICLOFENAC POTASSIUM
NOVARTIS (SINGAPORE) PTE LTD
M01AB05
50 mg
TABLET, SUGAR COATED
DICLOFENAC POTASSIUM 50 mg
ORAL
Prescription Only
Novartis Saglik, Gida ve Tarim Urunleri San. ve Tic. A.S.
ACTIVE
1991-04-08
CATAFLAM Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related substance. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Sugar-coated tablets. ACTIVE SUBSTANCE The active substance is potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac potassium). In Cataflam the sodium ion of diclofenac sodium (Voltaren ® ) has been replaced by a potassium ion. One Cataflam sugar-coated tablet contains 25 mg or 50 mg of diclofenac potassium. Certain dosage strengths may not be available in all countries. ACTIVE MOIETY Diclofenac EXCIPIENTS CORE: Magnesium stearate; povidone; silica colloidal anhydrous; sodium starch glycollate; maize starch; calcium phosphate. SUGAR-COAT: Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead); povidone; talc; sucrose. POLISH: polyethylene glycol 8000; sucrose. IMPRINT with printing ink brown for 25 mg and white for 50 mg. Pharmaceutical formulations may vary between countries. INDICATIONS Short-term treatment in the following acute conditions: Post-traumatic pain, inflammation and swelling, e.g. due to sprains. Post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhoea or adnexitis. Migraine attacks. Painful syndromes of the vertebral column. Novartis Page 2 Country Specific Package Leaflet (Singapore)30 Sep 2013 Cataflam tablets Non-articular rheumatism. As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsilliti read_full_document
Cataflam Sep 2022.SIN Page 1 of 14 TRADE-NAME(S) CATAFLAM Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related substance. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Sugar-coated tablets. ACTIVE SUBSTANCE The active substance is diclofenac potassium. In Cataflam ® the sodium ion of diclofenac sodium (Voltaren ® ) has been replaced by a potassium ion. One Cataflam sugar-coated tablet contains 25 mg or 50 mg of diclofenac potassium. Certain dosage strengths may not be available in all countries. EXCIPIENTS CORE: Magnesium stearate; povidone; silica colloidal anhydrous; sodium starch glycollate; maize starch; calcium phosphate. SUGAR-COAT: Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead); povidone; talc; sucrose. POLISH: polyethylene glycol 8000; sucrose. IMPRINT with printing ink brown for 25 mg and white for 50 mg. Pharmaceutical formulations may vary between countries. INDICATIONS Short-term treatment in the following acute conditions: • Post-traumatic pain, inflammation and swelling, e.g., due to sprains. • Post-operative pain, inflammation and swelling, e.g., following dental or orthopaedic surgery. • Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhoea or adnexitis. • Migraine attacks. • Painful syndromes of the vertebral column. • Non-articular rheumatism. • 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. Cataflam 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) read_full_document