البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
Laboratorios LICONSA, S.A.
RABEPRAZOLE SODIUM
10 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole Liconsa 10 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg of rabeprazole. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Pink, film-coated, biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole Liconsa gastro-resistant tablets are indicated for 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 therapy) 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 benign gastric ulcer_: The recommended oral dose for both duodenal ulcer and benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with duodenal ulcer heal within four weeks. However, some patients may require an additional four weeks of treatment to achieve healing. Most patients with benign active gastric ulcer heal within six weeks. However again some patients may require an additional six weeks of treatment 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 reflux disease, long-term management (GORD maintenance therapy):_ اقرأ الوثيقة كاملة