Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Sandoz SA (Pty) Ltd, 72 Steel Road, Spartan, Kempton Park, 1619
TOPRAFLUX 20 (enteric coated tablets).
TOPRAFLUX 40 (enteric coated tablets).
| Pharmaceutical Form |
|---|
|
Topraflux 20: A yellow, oval, enteric coated tablet; dimensions approximately 8,9 × 4,6 mm. Topraflux 40: A yellow, oval, enteric coated tablet; dimensions approximately 11,7 × 6,0 mm. |
Topraflux 20: Each enteric coated tablet contains pantoprazole sodium sesquihydrate equivalent to 20 mg of pantoprazole.
Topraflux 40: Each enteric coated tablet contains pantoprazole sodium sesquihydrate equivalent to 40 mg of pantoprazole.
Sugar free.
| Active Ingredient | Description | |
|---|---|---|
| Pantoprazole |
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells. |
| List of Excipients |
|---|
|
Calcium stearate, cellulose – microcrystalline, crospovidone Type A, ferric oxide yellow (E172), hydroxypropylcellulose (Type EXF), hypromellose, macrogol 400, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion, opadry yellow, polysorbate 80, ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake (E104), silica – colloidal anhydrous, sodium carbonate – anhydrous, sodium lauryl sulfate, titanium dioxide E171, triethyl citrate. |
White polyethylene containers with white polypropylene screw cap (tamper evident) with a desiccant insert, containing 14, 28, 30, 56, 100, 250, 300 or 500 tablets.
Aluminium foil and OPA/Al/PVC foil blisters strips packed in cardboard cartons, containing 14, 28, 30 or 56 tablets.
Sandoz SA (Pty) Ltd, 72 Steel Road, Spartan, Kempton Park, 1619
Topraflux 20: 43/11.4.3/0483
Topraflux 40: 43/11.4.3/0484
14 September 2012
| Drug | Countries | |
|---|---|---|
| TOPRAFLUX | South Africa |
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