EMAZOLE CONTROL 20MG TABLETS ESOMEPRAZOLE (7)
For short-term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 years and over.
The recommended dose is 20 mg esomeprazole (one capsule) per day.
It might be necessary to take the capsules 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.
Patients with renal impairment
Dose 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 (see section 5.2).
Patients with hepatic impairment
Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients with severe liver impairment should be advised by a doctor before taking Emazole Control (see sections 4.4 and 5.2).
Elderly patients (≥65 years old)
Dose adjustment is not required in elderly patients.
There is no relevant use of Emazole Control in the paediatric population below 18 years of age in the indication: “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”.
Method of administration
The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed.
Alternatively, the capsule can be opened and the contents dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. 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 should not be chewed or crushed.
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 Emazole Control as a long term preventive medicinal product.
Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile (see section 5.1).
Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.
Combination with other medicinal products
Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). 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. The use of esomeprazole with clopidogrel should be discouraged (see section 4.5).
Patients should not take another PPI or H2 antagonist concomitantly.
This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). 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 Emazole Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.