ESOMEPRAZOLE

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.

- Long-term management of patients with healed esophagitis to prevent relapse 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease (GERD) 20 mg 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. 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.

In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and - Healing of Helicobacter pylori associated duodenal ulcer and - Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Esomeprazole 20 mg 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. The treatment duration is 4-8 weeks.

Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily. v. induced prevention of rebleeding of peptic ulcers. v. induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison Syndrome The recommended initial dose is Esomeprazole 40 mg twice daily.

The dose 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 Patients with impaired renal function Dose adjustment is not required in patients with impaired renal function. 2). Patients with impaired hepatic function Dose adjustment is not required in patients with mild to moderate liver impairment.

Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.

No dose-related adverse reactions have been identified. Tabulated list of adverse reactions The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing.

None was found to be dose-related. The reactions are classified according to frequency: very common > 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10,000 to < 1/1,000; very rare < 1/10,000; not known (cannot be estimated from the available data).

g. 4); severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia. 4) Rare Arthralgia, myalgia Musculoskeletal and connective tissue disorders Very rare Muscular weakness Renal and urinary disorders Very rare Tubulointerstitial nephritis (with possible progression to renal failure); in some patients renal failure has been reported concomitantly.

Reproductive system and breast disorders Very rare Gynaecomastia General disorders and administration site conditions Rare Malaise, increased sweating Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App Store

g. 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 Esomeprazole gastro-resistant tablets may alleviate symptoms and delay diagnosis.

Long term use Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. On demand treatment Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character.

Helicobacter pylori eradication 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 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking other active substances metabolised via CYP3A4 such as cisapride.

1). Absorption of vitamin B12 Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

Hypomagnesaemia Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked.

In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

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