Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
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 Esoprim 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.

Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
To avoid this interference, Esoprim 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 Esoprim Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Sucrose
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 medicinal product.

Effects on Driving

4.7   Effects on ability to drive and use machines

Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as dizziness and visual disturbances are uncommon (see section 4.8). If affected, patients should not drive or use machines.