OMEZ Capsule Ref.[50944] Active ingredients: Omeprazole

Posology

RECOMMENDED DOSAGES FOR ADULTS

Duodenal ulcer: 20 mg once daily for two to four weeks. In some duodenal ulcer patients refractory to other treatment regimens, 40 mg once daily may be effective.

Prevention of relapse in patients with duodenal ulcer: 10 mg once daily. If necessary the dose can be increased to 20 to 40 mg once daily.

The above recommended dosage regimens are inclusive of Helicobacter pylori-positive duodenal ulcers as part of the eradication programme with appropriate antibiotics.

Gastric ulcer and reflux oesophagitis: 20 mg once daily for four to eight weeks.

In some gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg once daily may be effective.

For the long-term management of patients with reflux oesophagitis the recommended dose is 20 mg once daily. If necessary the dose can be increased to 20 to 40 mg once daily.

In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with OMEZ at a dosage of 20 mg once daily.

NSAID-associated gastro-duodenal lesions with or without continued NSAID treatment: 20 mg once daily.

In most patients healing occurs within 4 weeks. For patients who may not be fully healed after the initial course healing usually occurs during a further 4 weeks of treatment.

Prevention of NSAID-associated gastro-duodenal lesions and dyspeptic symptoms: 20 mg once daily.

Symptomatic gastro-oesophageal reflux disease: 20 mg daily.

Patients may respond adequately to 10 mg daily; therefore individual dose adjustments should be considered.

If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily further investigation is recommended.

Zollinger-Ellison Syndrome: 60 mg once daily.

The dosage should be adjusted individually and treatment continued as long as it is clinically indicated. With doses above 80 mg daily the dose should be divided and given twice daily.

There is very limited experience with the use of OMEZ in children(see Section 4.4).

Severe ulcerative reflux oesophagitis in children from one year and older:

Recommended dosages:

Special populations

Elderly

Dose reductions are not necessary in elderly patients. The long-term safety of OMEZ in patients with renal and hepatic impairment has not been established (see Section 4.4).

Impaired renal function

Dose reductions are not necessary in renal impairment.

Impaired hepatic function

Bioavailability and plasma half-life of OMEZ are increased in patients with impaired hepatic function, therefore a daily dose of 10 to 20 mg is generally sufficient.

Method of administration

OMEZ is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsules should not be chewed or crushed.

Blurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea and tachycardia have been reported from over-dosage with omeprazole. There is no specific antidote for overdose with omeprazole.

TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.

Due to extensive protein binding omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner/doctor consultation.

3 years.

Store at or below 25 °C. Protect from light and moisture.

Keep the blisters in the outer carton until required for use.

The containers must be tightly closed.

OMEZ 10: Blister packaging containing 30 or 100 capsules. White HDPE bottles containing 30 or 100 capsules.

OMEZ 20: Blister packaging containing 14, 30 or 100 capsules. White HDPE bottles containing 14, 30, 100 or 1000 capsules.

OMEZ 40: Blister packaging containing 14, 28, 30 or 100 capsules. White HDPE bottles containing 30, 100 or 500 capsules.

Any unused product or waste material should be disposed of in accordance with local requirements.