NEXIUM 40 MG 28 TAB

* Gastro-resistant tablets. * Therapeutic indications: Nexium tablets are indicated for: & & # Gastroesophageal Reflux Disease (GERD): & & – treatment of erosive reflux esophagitis. & & – long-term management of patients with healed oesophagitis to prevent relapse. & & – symptomatic treatment of gastro-oesophageal reflux disease (GORD). & & # In combination with appropriate antibacterial therapeutic regimen for the eradication of & & Helicobacter pylori and & & – healing of duodenal ulcer associated with Helicobacter pylori and & & – 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. * CONTRAINDICATIONS: & & – Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents & & of the formulation. & & – Esomeprazole like other PPIs should not be administered with atazanavir. * Special warnings and special precautions for use: & & – In the presence of any alarm symptom (eg. significant unintentional weight loss, recurrent vomiting, & & dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy & & should be excluded, as treatment with Nexium may alleviate symptoms and delay diagnosis. & & – Patients on long-term treatment (particularly those treated for more than a year) should be kept under & & regular surveillance. & & – Patients on on-demand treatment should be instructed to contact their physician if their symptoms change & & in character. When prescribing esomeprazole for on demand therapy, the implications for interactions & & with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole should be considered. & & – When prescribing esomeprazole for eradication of Helicobacter pylori possible drug interactions for all & & components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 & & is used in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride. & & – This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, & & glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. * Pregnancy and lactation: & & – For Nexium, limited clinical data on exposed pregnancies are insufficient. Caution should be exercised & & when prescribing to pregnant women. & & – It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women & & have been performed. Therefore NEXIUM should not be used during breast-feeding. * Effects on ability to drive and use machines: & & No effects have been observed. * Posology and method of administration: & & – The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. & & – For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of & & non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. & & Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. & & Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. & & – For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered & & through a gastric tube. It is important that the appropriateness of the selected syringe and tube is & & carefully tested. & & # Gastro-Oesophageal Reflux Disease (GORD): & & . Treatment of erosive reflux oesophagitis: 40 mg once daily for four weeks. & & An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or & & who have persistent symptoms. & & . Long-term management of patients with healed oesophagitis to prevent relapse: 20 mg once daily. & & . Symptomatic treatment of gastro-oesophageal reflux disease (GORD): 20 mg once daily in patients & & without esophagitis. If symptom control has not been achieved after four weeks, the patient should & & be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved & & using an on demand regimen taking 20 mg once daily, when needed. In NSAID treated patients at risk & & of developing gastric and duodenal ulcers, subsequent symptom control using an on demand regimen & & is not recommended. & & # In combination with appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and & & – healing of duodenal ulcer associated with Helicobacter pylori and & & – prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers. & & 20 mg NEXIUM with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days. & & # Patients requiring continued NSAID therapy: & & – Healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily for 4 to 8 weeks. & & – Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily. & & # Children and Adolescents 12-18 years. Nexium should not be used in children since no data is available. & & # Impaired renal function: Dosage adjustment is not required in patients with impaired renal function. & & Due to limited experience in patients with severe renal insufficiency, such patients should be & & treated with caution. & & # Impaired hepatic function: Dose adjustment is not required in patients with mild to moderate liver impairment. & & For patients with severe liver impairment, a maximum dose of 20 mg NEXIUM should not be exceeded. & & # Elderly: Dose adjustment is not required in the elderly. * To be taken as directed by the physician. * Do not store above 30 degrees C. * The tablets should be swallowed whole with water or dispersed in non-carbonated water. Do not chew or crush the pellets in the tablets. * Packed by: AstraZeneca Egypt. Under License of: AstraZeneca – Sweden. & & Nexium is a Trade Mark