Indication
Benign gastric and duodenal ulcers including those complicating NSAID therapy. Erosive reflux esophagitis and for disorders associated with hypersecretion of gastric acid, such as the Zollinger Ellison syndrome, peptic ulcer associated with Helicobacter pylori.

Dosage and administration
Roceptin capsule should be taken before meal.
Gastric and duodenal ulcers including those complicating NSAID’s therapy: 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration. In severe cases the dose may be increased to 40 mg daily.
Healing of reflux esophagitis: The usual dose is 20 mg once daily for 4 weeks followed by a further 4-8 weeks if not fully healed. 40 mg daily has been given for 8 weeks in reflux esophagitis refractory to other treatment, may be continued at 20 mg daily.
Zollinger-Ellison syndrome: Initially 60 mg once daily, usual range 20-120 mg daily (above 80 mg in two divided doses). Larger doses of up to 180 mg daily in divided doses may be used or as prescribed by the physicians.
Elderly: Dose adjustment is not required in the elderly.
Impaired hepatic function: As bioavailability and half life can be increased in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.
Treatment of Helicobacter pylori:

Contraindication
There are no known contraindications to the use of Roceptin. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Roceptin is instituted as treatment may alleviate symptoms and delay diagnosis.

Precaution
Symptomatic response to therapy with Roceptin (Omeprazole) does not preclude the presence of gastric malignancy.

Side effects
Roceptin (Omeprazole) is well tolerated. Mild and transient side effects include nausea, diarrhea, abdominal colic, paresthesia, dizziness and headache, but in these cases reduction in dosage is not required.

Use in pregnancy and lactation
The drug should be avoided in pregnancy unless there is no safer alternative. Breast feeding should be discontinued if the use of Roceptin is considered essential.
Drug interaction
Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. There is no evidence of an interaction with theophylline, propranolol or antacids.

Pharmaceutical precaution
Store in a cool, dry place and protect from light. Keep out of reach of children.

Packing
Roceptin-20 Capsule: Box containing 10 x 6/10 x 10 capsules in alu-alu blister pack.
Roceptin-40 Capsule: Box containing 4 x 5/5 x 6/5 x 10/ 10 x 10 capsules in alu-alu blister pack.