Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: NOVARTIS SOUTH AFRICA (PTY) LTD, Magwa Crescent West, Waterfall City, Jukskei view, Johannesburg, 2090, +27113476600
VOLTAREN 25 TABLETS
VOLTAREN GT 50 TABLETS
VOLTAREN 75 TABLETS
VOLTAREN SIMPLE REGIMEN 100 TABLETS
VOLTAREN 75 AMPOULES
VOLTAREN 25 SUPPOSITORIES
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VOLTAREN 25: Yellow, round, slightly biconvex, enteric-coated tablet with bevelled edges. Printed one side CG and the other side BZ. VOLTAREN GT 50: Light brown, round, slightly biconvex, enteric-coated tablet with bevelled edges. Printed one side CG and the other side GT. VOLTAREN 75 TABLETS: Pale pink, triangular, slightly biconvex, film coated tablets. Printed CG or Geigy on one side and ID on the other, or no printing on either side. VOLTAREN SIMPLE REGIMEN 100: Pink, round, film coated, slightly biconvex with bevelled edges. Printed one side CG and the other side CGC. VOLTAREN 75 AMPOULES: Clear, colourless to faintly yellowi solution contained in clear, glass, labelled ampoules. VOLTAREN 25 SUPPOSITORIES: Yellowish-white, torpedo shaped, approximately 1 g in mass. VOLTAREN 100 SUPPOSITORIES: Yellowish-white, torpedo shaped, approximately 2 g in mass. |
The active ingredient is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac sodium).
One enteric-coated tablet contains 25 mg diclofenac sodium.
Contains sugar: 16 mg lactose monohydrate.
One enteric-coated tablet contains 50 mg diclofenac sodium.
Contains sugar: 25 mg lactose monohydrate.
One film-coated tablet contains 75 mg diclofenac sodium.
Contains sugar: 90,8 mg sucrose.
One film-coated tablet contains 100 mg diclofenac sodium.
Contains sugar: 119 mg sucrose.
One 75 mg/3 mL ampoule contains 75 mg diclofenac sodium.
Excipients with known effect:
Contains sugar: 18 mg mannitol.
Preservative: benzyl alcohol 4% mass/volume.
Antioxidant: sodium metabisulphite 0,067% mass/volume.
Voltaren Ampoules contains 600 mg propylene glycol.
One suppository contains 25 mg and 100 mg diclofenac sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient |
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Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms. |
| List of Excipients |
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Voltaren 25: colloidal anhydrous silica, lactose (16 mg), maize starch, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate (1 mg); hypromellose, yellow iron oxide (E172), purified talc, titanium dioxide (E171), methacrylic acid copolymer, polyethylene glycol 8000, simeticone, polyoxyethylene 40 hydrogenated castor oil. Voltaren GT 50: colloidal anhydrous silica, lactose (25 mg), maize starch, sodium starch glycollate povidone, microcrystalline cellulose, magnesium stearate (1,5 mg); hypromellose, yellow iron oxide (E172), purified talc, titanium dioxide (E171), methacrylic acid-copolymer, polyethylene glycol 8000, simeticone, red iron oxide (E172), polyoxyethylene 40 hydrogenated castor oil. Voltaren 75: colloidal anhydrous silica, sucrose, cetyl alcohol, povidone, magnesium stearate; hypromellose, purified talc, polysorbate 80, titanium dioxide (E171), red iron oxide (E172), polyethylene glycol 8000, printing ink: Black (Opacode S-1-8015), shellac; medicinal charcoal. Voltaren SIMPLE REGIMEN SR 100: colloidal anhydrous silica, sucrose, cetyl alcohol, povidone, magnesium stearate; hypromellose, purified talc, polysorbate 80, titanium dioxide (E171), red iron oxide (E172), polyethylene glycol 8000, printing ink: Black (Opacode S-1-8015), shellac; medicinal charcoal. VOLTAREN AMPOULES: mannitol; sodium metabisulphite (E223); benzyl alcohol; propylene glycol; water for injection; sodium hydroxide; nitrogen (pure). VOLTAREN SUPPOSITORIES: Hard fat. |
VOLTAREN 25 is supplied as enteric-coated tablets of 25 mg in packs of 30 and 50.
VOLTAREN GT 50 is supplied as enteric-coated tablets of 50 mg in blister packs of 15 and 20.
VOLTAREN 75 TABLETS are supplied in packs of 10 and 30.
VOLTAREN SIMPLE REGIMEN 100 tablets are supplied in blister packs of 28 and 30.
VOLTAREN 75 AMPOULES: 75 mg/3 mL in packs of 5, 50 and 200.
VOLTAREN 25 SUPPOSITORIES and VOLTAREN 100 SUPPOSITORIES are supplied in packs of 5.
NOVARTIS SOUTH AFRICA (PTY) LTD, Magwa Crescent West, Waterfall City, Jukskei view, Johannesburg, 2090, +27113476600
VOLTAREN 25 (enteric coated): G/3.1/83
VOLTAREN GT 50 (enteric coated): K/3.1/253
VOLTAREN 75 TABLETS: Y/3.1/346
VOLTAREN SIMPLE REGIMEN 100: M/3.1/63
VOLTAREN 75 AMPOULES: H/3.1/34
VOLTAREN 25 SUPPOSITORIES: R/3.1/224
VOLTAREN 100 SUPPOSITORIES: L/3.1/126
November 2007
| Drug | Countries | |
|---|---|---|
| VOLTAREN | Albania, Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa |
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