Compositon/Ingredients: Esomeprazole

• Gastro-oesophageal reflux disease (GORD).
• Peptic ulcer disease caused by H. pylori.
• Prophylaxis for NSAID-associated ulceration.
• Zollinger-Ellison syndrome.

Known hypersensitivity to any of the active substance or excipients.

Pregnancy in the first trimester.

Adults and adolescents from the age of 12 years:

• Treatment of erosive reflux oesophagitis: 40mg once daily in 4 weeks (if oesophagitis has not healed or persistent symptoms: 8 weeks).
• Long-term management of patients with healed oesophagitis to prevent relapse: 20mg once daily.
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD): 20mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.

Adults:

• In combination with an appropriate antibacterial therapeutic regimen for the eradication of pylori and prevention of relapse of peptic ulcers in patients with H. pylori [20mg Esomeprazole + 1g Amoxicillin + 500mg Clarithromycin] twice daily in 7 days.
• Healing of gastric ulcers associated with NSAID therapy: 20mg once daily in 4-8 weeks.
• Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20mg once daily.
• Zollinger-Ellison syndrome: Initial 40mg twice daily, then individually adjust. Doses between 80 to 160mg daily (doses > 80mg daily should be divided and given twice).

Children younger than 12 years of age: Should not use.

Patients with severe liver impairment: The maximum dose is 20mg.

• Patients with severe renal insufficiency.
• Malignancy should be excluded before using esomeprazole.
• Using esomeprazole in high doses and over long durations (> 1 year) may modestly increase the risk of hip, wrist and spine fracture.
• Hypomagnesemia can occur because of using prolonged treatment or taking proton pump inhibitor with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics).
• Contraindications for clarithromycin should be considered in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride.
• Decreased gastric acidity due to drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
• Pregnancy (only use when clearly needed), lactation (should not use).
• Patients who experience vertigo or hallucinations while taking esomeprazole should refrain from driving or using machines.

Store at temperature below 30°C, protect from light.