Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
Clonmel Healthcare Ltd
20 Milligram
Tablets Gastro-Resistant
2011-09-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabiclon 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rabiclon 20 mg gastro-resistant tablets One gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Rabiclon 20 mg gastro-resistant tablets are yellow, round biconvex, coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabiclon 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 t Прочитајте комплетан документ