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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole sodium Specifar 20mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Yellow, round, biconvex gastro-resistant tablets with a diameter of 7.5 mm approximately.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole sodium Specifar tablets are indicated for the treatment of:
Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).
Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance)
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD)
Zollinger-Ellison Syndrome
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in
patients with peptic ulcer disease (See section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS/ELDERLY:
_ACTIVE DUODENAL ULCER AND ACTIVE BENIGN GASTRIC ULCER: _The recommended oral dose for both active duodenal ulcer
and active benign gastric ulcer is 20 mg to be taken once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional
four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks.
However again a few patients may require an additional six weeks of therapy to achieve healing.
_EROSIVE OR ULCERATIVE GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): _The recommended oral dose for this condition is
20 mg to be taken once daily for four to eight weeks.
_GASTRO-OESOPHAGEAL
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