A R I S T O P H A R M A L T D.

Omep-IR (Omeprazole/sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid.

Omep-IR Capsule: Each immediate-release capsules contains 20 mg of omeprazole and 1100 mg of sodium bicarbonate as enteric-coated pellets

Duodenal Ulcer; Gastric Ulcer; Treatment of Gastroesophageal Reflux Disease (GERD); Symptomatic GERD Erosive Esophagitis; Maintenance of Healing of Erosive Esophagitis; Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients.

Dosage and Administration

Indication	Recommended Dose	Frequency
Short-Term Treatment of Active Duodenal Ulcer	20 mg	Once daily for 4 weeks*,⁺
Benign Gastric Ulcer	40 mg	Once daily for 4-8 weeks **,⁺
Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD (with no esophageal erosions)	20 mg	Once daily for up to 4 weeks⁺
Erosive Esophagitis	20 mg	Once daily for 4-8 weeks⁺
Maintenance of Healing of Erosive Esophagitis	20 mg	Once daily**
Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40 mg oral suspension only)	40 mg	40 mg initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days**

Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.
Omep-IR capsule should be taken on an empty stomach at least one hour before a meal.

Administration of Capsules

Omep-IR Capsules should be swallowed intact with water. Do not use other liquids. Do not open capsule and sprinkle contents into food.

Impaired hepatic function: As bioavailability and half-life can be increased in patient with impaired hepatic function. The dose requires adjustment with a maximum daily dose of 20 mg.

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

Omep is generally well tolerated. Nausea, diarrhoea, flatulence, abdominal pain, constipation, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage. Skin rash, urticaria and pruritus have been reported, usually resolved after discontinuation of the treatment.

There is no evidence on the safety of Omep in human pregnancy. Avoid in pregnancy unless there is no safer alternative. There is no information available on the passage of Omep into milk or its effects on the neonate. Breast-feeding should therefore be discontinued if the use of Omep is considered essential.

Omep can delay the elimination of diazepam, phenytoin and warfarin. There is no evidence of an interaction with theophylline, propranolol or antacids.

Store in a cool and dry place, away from light. Keep put of the reach of children.