OMEPRAZOLE ENTERIC CAPSULE 20MG

Indications:

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID-associated gastric and duodenal ulcers

• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux oesophagitis

• Long-term management of patients with healed reflux oesophagitis

• Treatment of symptomatic gastro-oesophageal reflux disease

Dosage and Administration:

Omeprazole Enteric Capsule is recommended to take Omeprazole capsules in the morning, swallowed whole with half a glass of water. The capsules must not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food.

Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g., fruit juice or applesauce, or in non-carbonated water. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water.

Alternatively patients can suck the capsule and swallow the pellets with half a glass of water. The enteric-coated pellets must not be chewed.

Precautions & Warning:

The dosage schemes given above are usually satisfactory, but regular examination of the blood is advisable. If megaloblastic anaemia fails to respond to Cytamen, folate metabolism should be investigated. Doses in excess of 10mcg daily may produce an incomplete haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. The haematological and neurological state should be monitored regularly to ensure adequacy of therapy. Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period. Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrence of reactive thrombocytosis.

Contra-indications:

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.

Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir.

Drug interactions:

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

Coadministration of atazanavir with proton pump inhibitors is not recommended.

Omeprazole, as all acid-blocking medicinal products, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g., diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.

Storage instructions:

Do not store above 25°C.