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OMEZ 20 (capsule)

Information leaflet

OMEZ 10 (capsule)
OMEZ 20 (capsule)
OMEZ 40 (capsule)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OMEZ 10 (capsule)
OMEZ 20 (capsule)
OMEZ 40 (capsule)

COMPOSITION:
OMEZ 10: Each capsule contains omeprazole 10 mg
OMEZ 20: Each capsule contains omeprazole 20 mg
OMEZ 40: Each capsule contains omeprazole 40 mg

PHARMACOLOGICAL CLASSIFICATION
A 11.4.3 Medicines acting on the gastrointestinal tract –Other

PHARMACOLOGICAL ACTION
Omeprazole is an inhibitor of the gastric proton pump (H+, K+-ATPase). It inhibits both basal and stimulated gastric acid
secretion by parietal cells, whether induced by acetylcholine, gastrin or histamine.
Omeprazole has no effect on acetylcholine, histamine or gastric receptors.
Pharmacokinetics
Orally administered omeprazole is well absorbed but to a variable extent. Absorption of omeprazole takes place in the
small intestine and is usually completed within three to six hours. Bioavailability depends on dose and gastric pH and
may reach 70% with repeated administration. Food has no influence on the bioavailability of omeprazole.
Omeprazole is more than 95% bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a
plasma half-life of 30 to 90 minutes.
Hepatic metabolism occurs primarily via the cytochrome P450 (CYP) isoform (CYP2C19). The inactive metabolites are
excreted mainly in the urine (80%) whilst the remaining 20% are excreted via the faeces. The average half-life of the
terminal phase of the plasma concentration-time curve is approximately 40 minutes. There is no change in plasma half-
life during treatment. The inhibition of acid secretion is related to the area under the plasma concentration - time curve
(AUC) and not to the actual plasma concentration at a given time.

INDICATIONS
OMEZ is indicated in:
Adults
• Treatment of duodenal ulcer, including prevention of relapse gastric ulcer and reflux oesophagitis.
• Long-term management of reflux oesophagitis and Zollinger-Ellison Syndrome.
• Symptomatic relief of heartburn in patients with gastro-oesophageal reflux disease (GORD) and the short-term relief of
  functional dyspepsia.
• Helicobacter pylori-positive duodenal ulcers as part of an eradication programme with appropriate antibiotics.
• Treatment of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric and/or duodenal ulcer/erosions.
• Reduction of the risk to develop gastric and/or duodenal ulcer/erosions and reduction of the risk of relapse for
  previously healed gastric and/or duodenal ulcer/erosions in patients on NSAID treatment.
Children
 Short-term (up to 3 months) treatment of severe ulcerative reflux oesophagitis resistant to previous medical treatment.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients
Safety in pregnancy and lactation has not been established

WARNINGS
Symptomatic response to OMEZ therapy does not preclude the presence of gastric ulcer or malignancy or a malignant
disease of the oesophagus. The administration of OMEZ in this situation may delay diagnosis (see Special Precautions).
Hepatic impairment may require a reduction in dose (see DOSAGE AND DIRECTIONS FOR USE).
THERE IS VERY LIMITED EXPERIENCE WITH THE USE OF OMEZ IN CHILDREN.
THE LONG-TERM SAFETY OF OMEZ IN PATIENTS WITH RENAL AND/OR HEPATIC IMPAIRMENT HAS
NOT BEEN ESTABLISHED.
THIS MEDICINE MAY LEAD TO DROWSINESS AND IMPAIRED CONCENTRATION THAT MAY BE
AGGRAVATED BY THE SIMULTANEOUS INTAKE OF ALCOHOL OR OTHER CENTRAL NERVOUS SYSTEM
DEPRESSANTS. PATIENTS SHOULD BE ADVISED, PARTICULARLY AT THE INITIATION OF THERAPY,
AGAINST TAKING CHARGE OF VEHICLES OR MACHINERY OR PERFORMING POTENTIALLY
HAZARDOUS TASKS WHERE LOSS OF CONCENTRATION COULD LEAD TO ACCIDENTS.

INTERACTIONS
OMEZ is metabolised via the hepatic P450 cytochrome enzyme system, which may affect the metabolism of other
medications metabolised by these enzymes, when given concomitantly. The elimination of diazepam, warfarin and
phenytoin may be prolonged when OMEZ is given concomitantly.
Monitoring of INR and phenytoin serum levels is recommended and dosage reductions may be necessary when OMEZ is
given concomitantly. There is a possible interaction of OMEZ with digoxin and a 10% increase in digoxin
bioavailability may be expected.
There may be interactions with other medicines, which are also metabolised via the cytochrome P450 enzyme system.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established (see CONTRAINDICATIONS).

DOSAGE AND DIRECTIONS FOR USE
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.
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 –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 –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.
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