ESOMEPRAZOLE

Posology Adults aged 18 years and over The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks.

Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Special populations Patients with renal impairment Dose adjustment is not required in patients with impaired renal function.

2). Patients with hepatic impairment Dose adjustment is not required in patients with mild to moderate liver impairment. 2). Elderly patients (≥65 years old) Dose adjustment is not required in the elderly. , heartburn and acid regurgitation)”.

Method of administration The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. Alternatively, 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.

The water should be stirred until the tablet disintegrates. The liquid with the pellets should be drunk immediately or within 30 minutes. The glass should be rinsed with half a glass of water and the water drunk. The pellets must not be chewed or crushed.

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 MedDRA frequency convention: 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). 4) arthralgia, myalgia muscular weakness Renal and urinary disorders Tubulointerstitial nephritis (with possible progression to renal failure) Reproductive system and breast disorders gynaecomastia General disorders and administration site disorders 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 for MHRA Yellow Card in the Google Play or Apple App Store.

General Patients should be instructed to consult a doctor if: - They have 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 may alleviate symptoms and delay diagnosis.

- They have had previous gastric ulcer or gastrointestinal surgery. - They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. - They have jaundice or severe liver disease. - They are aged over 55 years with new or recently changed symptoms.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.

Patients should not take Esomeprazole 20 mg Gastro-resistant Tablets as a long term preventive medicinal product. 1). Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.

5). If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with active substances metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole.

The clinical relevance of this interaction is uncertain. 5). Patients should not take another PPI or H2 antagonist concomitantly. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.

1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment. Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE.

If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Esomeprazole 20 mg Gastro-resistant Tablets.

SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Esomeprazole 20 mg Gastro-resistant Tablets contain sucrose and lactose This medicinal product contains sucrose and lactose.

Patients with rare hereditary problems of fructose and/or galactose intolerance, the total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. General Patients should be instructed to consult a doctor if: - They have 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 may alleviate symptoms and delay diagnosis.

- They have had previous gastric ulcer or gastrointestinal surgery. - They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. - They have jaundice or severe liver disease. - They are aged over 55 years with new or recently changed symptoms.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.

Patients should not take Esomeprazole 20 mg Gastro-resistant Tablets as a long term preventive medicinal product. 1). Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.

5). If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Esomeprazole 20 mg should not be exceeded.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole.

The clinical relevance of this interaction is uncertain. 5). Patients should not take another PPI or H2 antagonist concomitantly. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.

1). If CgA and gastrin […]

1. 5).