1. Name of the medicinal product Nexium 40 mg gastro-resistant tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 44.5 mg esomeprazole magnesium trihydrate equivalent to 40 mg esomeprazole. Excipient(s) with known effect Each gastro-resistant tablet contains 30 mg sucrose For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and on the other side. 4. Clinical particulars 4.1 Therapeutic indications Nexium tablets are indicated in adults for: Gastroesophageal Reflux Disease (GERD) – treatment of erosive reflux esophagitis. Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison Syndrome Nexium tablets are indicated in adolescents from the age of 12 years for: Gastroesophageal Reflux Disease (GERD) - treatment of erosive reflux esophagitis 4.2 Posology and method of administration Posology Adults Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms. Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers. 40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison Syndrome The recommended initial dosage is Nexium 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Special Populations Renal impairment Dose adjustment is not required in patients with impaired renal fun