Therapeutic indications

• Duodenal ulcers
• Benign gastric ulcers
• Gastroesophageal reflux
• Zollinger-Ellison syndrome
• Treatment of duodenal or gastric ulcer associated with the use of NSAID(nonsteroidal anti-inflammatory drugs)
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated peptic ulcers

Duodenal ulcers
The usual dose is 20 mg once daily. The duration of the treatment is 2-4 weeks.

Maintenance treatment :
In maintenance treatment for prevention of recurrence of duodenal ulcer not responding to eradication of Helicobacter pylori the treatment should be individualised depending on the clinical response. The normal dose is 20 mg daily. For some patients 10 mg may be sufficient.

Benign gastric ulcers :
The usual dose is 20 mg once daily. The duration of the treatment is 4-8 weeks.

Gastroesophageal reflux
The usual dose is 20 mg once daily. The duration of treatment is 4-8 weeks.

Notes:
In isolated cases of duodenal ulcers, benign gastric ulcers and reflux oesophagitis the dosage of omeprazole can be increased to 40 mg omeprazole once daily.

Only if eradication therapy is not indicated or has been unsuccessful, duodenal and gastric ulcers may be treated with omeprazole monotherapy.

Maintenance treatment of reflux oesophagitis to prevent relapse : The usual dose is to 10 to 20 mg once daily depending on the clinical response.

Symptomatic treatment of gastro-oesophageal reflux disease :
The usual dose is to 10 to 20 mg once daily depending on clinical response. The treatment duration is 2 to 4 weeks. If the patient does not experience any improvement in symptoms after a 2 weeks treatment further examinations should be performed.

Zollinger-Ellison syndrome:
The dosage should be adjusted individually and continued under specialist supervision as long as clinically indicated. The recommended initial dosage is 60 mg once daily. With doses above 80 mg daily, the dose should be divided and given twice daily. In patients with Zollinger-Ellison syndrome the treatment is not subject to a time limit.

Treatment of NSAID related gastric and duodenal ulcers: 
The usual dose is 20 mg once daily. The treatment duration is 4 to 8 weeks.

Maintenance treatment of NSAID related gastric and duodenal ulcers to prevent relapse:
The usual dose is 20 mg once daily.

Eradication therapy:
Patients with peptic ulcers due to Helicobacter pylori infection should be treated with eradication therapy with appropriate combinations of antibiotics with adequate dosing regimens. The selection of an appropriate regimen should be based on patient tolerability and therapeutic guidelines.

The following combinations have been tested:

• Omeprazole 20 mg, Amoxicillin 1000 mg, Clarithromycin 500 mg all 2 times daily
• Omeprazole 20 mg, Clarithromycin 250 mg, Metronidazole 400-500 mg all 2 times daily

The treatment duration for the eradication is 1 week. To avoid the development of resistance the treatment duration should not be reduced. In patients with active ulcers an extension of the therapy with omeprazolemonotherapy according to the posology and treatment duration given above may be performed.

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment ( most commonly 7 days but sometime up to 14 days) and appropriate use of antibacterial agents. Metronidazole should not be considered as first choice because of mutagenic and carcinogenic properties in animal studies.

Impaired hepatic function: 
The dose should be reduced in patients with impaired hepatic function. The maximum daily dose is 20 mg.

Contraindications
Omeprazole is contraindicated in patients with hypersensitivity to omeprazle or other substituted benzimidazoles or any of the excipients.

Adverse reactions
Omeprazole generally is well tolerated. The most frequent adverse effects associated with omeprazole therapy involve the GI tract (e.g. diarrhea, nausea, constipation, abdominal pain, vomiting) and the CNS (e.g. headache, dizziness). Upper respiratory tract infection, cough, back pain, marked increases in serum (e.g. ALT (SGPT), AST (SGOT) and alkaline phosphatase ), liver disease, rash acute interstitial nephritis and sexual disturbance.
If you notice some of these effects or any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Precaution

1. If you are pregnant, only take Moprix on the advice of your doctor.
2. If you are taking any of the following medicines :

• Itraconazole, ketoconazole, ( omeprazole may result in a reduction in absorbtion of these medicines)
• diazepam, anticoagulants, coumarin (warfarin ) or indandione-derivative or phenytoin (omeprazole may result in delayed elimination of these medicines)

Storage condition
Keep out of reach and sight of children.
Do not store above 25°C.
Manufacturer LABORATORIOS LICONSA, S.A. GUADALAJARA, SPAIN
Imported by SINENSIX PHARMA ( THAILAND ) CO., LTD, BANGKOK, THAILAND