Therapeutic indications

• Gastric ulcers
• Duodenal ulcers
• Benign gastric ulcers
• Gastroesophageal reflux
• Zollinger-Ellison syndrome
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated peptic ulcers

Posology and method of administration
Gastric ulcers
The usual dose is 40 mg once daily. The duration of the treatment
is 4-8 weeks.

In duodenal ulcers, benign gastric ulcers and reflux oesophagitis
the usual dosage of omeprazole is 20 mg daily, but in isolated
cases the dose may 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.

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.

Peptic ulcer associate with Helicobacter pylori infection;
Omeprazole 40 mg once a day before breakfast taken in
combination with clarithromycin 500 mg three times a day for the
first fourteen days. For days 15 through 28, further treatment with
omeprazole 20 mg once a day before breakfast follows.

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

Usual pediatric dose
Safety and efficacy have not been established.

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

Adverse reactions
OMEPROL generally is well tolerated. The most frequent adverse
effects associated with OMEPROL 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 OMEPROL 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
Do not store above 25°C.
Store all drug properly and keeps them out of reach of children.

Manufactured byLABORATORIOS RECALCINE  S.A. – Sandiago, Chile
Imported by Sinensix Pharma (Thailand) Co., Ltd. Bangkok, Thailand