Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Arrow Generics Limited
40 Milligram
Tablets Gastro-Resistant
2012-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole Arrow 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg esomeprazole (as magnesium dihydrate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet A pink, oblong, biconvex, film coated tablet, with “40” engraved on one side and dimensions of approximately 17.2 x 8.7 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Esomeprazole Arrow tablets are indicated for: GASTROOESOPHAGEAL REFLUX DISEASE (GORD): -Treatment of erosive reflux oesophagitis -Long-term management of patients with healed oesophagitis to prevent relapse -Symptomatic treatment of gastrooesophageal reflux disease (GORD) IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER_ _PYLORI_: -Healing of _Helicobacter pylori _associated duodenal ulcer -Prevention of relapse of peptic ulcers in patients with _Helicobacter pylori _associated ulcers PATIENTS REQUIRING CONTINUED NSAID THERAPY: -Healing of gastric ulcers associated with NSAID therapy -Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS. TREATMENT OF ZOLLINGER ELLISON SYNDROME. Adolescents from the age of 12 years GASTROOESOPHAGEAL REFLUX DISEASE (GORD) - treatment of erosive reflux oesophagitis - long-term management of patients with healed oesophagitis to prevent relapse - symptomatic treatment of gastrooesophageal reflux disease (GORD) IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED BY HELICOBACTER PYLORI 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be swallowed whole with liquid. The Read the complete document