Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
Teva Pharma B.V.
20 Milligram
Tablets Gastro-Resistant
2010-12-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole sodium Teva 20 mg Gastro -resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro -resistant tablet contains 20 mg of rabeprazole sodium. Excipients: Each gastro -resistant tablet contains 0.68 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro -resistant tablet. Yellow, round tablet, imprinted in black ink with "93" on one side and "64" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole is 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 Read the complete document