SOMEZOL Capsule

In patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

None found to be dose-related

Common: Headache, abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation

Uncommon: Dermatitis, pruritis, urticaria, dizziness, dry mouth

Rare: Hypersensitivity reactions e.g. angioedema, anaphylactic reaction

Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. Coadministration of oral contraceptives, diazepam, phenytoin, or quinidine did not seem to change the pharmacokinetic profile of Esomeprazole. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, iron salts and digoxin).

Pregnancy

Teratogenic Effects: Pregnancy Category B- Teratology studies have been performed in rats at oral doses up to 280mg/kg/day (about 57 times the human dose on a body surface area basis) and in rabbits at oral doses up to 86mg/kg/day (about 35 times the human dose on a body surface area basis) and have revealed no evidence of impaired fertility or harm to the fetus due to Esomeprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

The excretion of Esomeprazole in milk has not been studied. However, omeprazole concentrations have been measured in breast milk of a woman following oral administration of 20mg. Because Esomeprazole is likely to be excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

General

In the presence of any alarming symptoms (e.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 may alleviate symptoms and delay diagnosis. Patients on long term treatment (particularly those treated for more than a year) should be kept under regular surveillance since the symptomatic response to therapy with Esomeprazole does not preclude the gastric malignancy.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences is safety and efficacy sere observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.