Indications And Usage

Omeprazole capsules are indicated in:

Adults

• 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

• Treatment of Zollinger-Ellison syndrome

Administration

It is recommended to take Exiprazole 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.

Contraindications

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

Precautions

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.

Adverse Reactions

headache, abdominal pain, diarrhea, nausea, vomiting, gas (flatulence), dizziness, upper respiratory infection, acid reflux, constipation, rash, cough.

Pregnancy and lactation

Pregnancy:

Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.

Breast-feeding:

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Renal and liver Impairment

Renal impairment

Dose adjustment is not needed in patients with impaired renal function

Hepatic impairment

In patients with impaired hepatic function a daily dose of 10–20 mg may be sufficient

Laboratory Tests