OMEPRAZOLE Gastro-resistant capsules Ref.[7023] Active ingredients: Omeprazole

Posology

Adults

Treatment of duodenal ulcers

The recommended dose in patients with an active duodenal ulcer is Omeprazole 20mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulcer Omeprazole 40mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers

For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is Omeprazole 20mg once daily. In some patients a daily dose of 10mg may be sufficient. In case of therapy failure, the dose can be increased to 40mg.

Treatment of gastric ulcers

The recommended dose is Omeprazole 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period. In patients with poorly responsive gastric ulcer Omeprazole 40mg once daily is recommended and healing is usually achieved within eight weeks.

Prevention of relapse of gastric ulcers

For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is Omeprazole 20mg once daily. If needed the dose can be increased to Omeprazole 40mg once daily.

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

• Omeprazole 20mg + clarithromycin 500mg + amoxicillin 1,000mg, each twice daily for one week, or
• Omeprazole 20mg + clarithromycin 250mg (alternatively 500mg) + metronidazole 400mg (or 500mg or tinidazole 500mg), each twice daily for one week or
• Omeprazole 40mg once daily with amoxicillin 500mg and metronidazole 400mg (or 500mg or tinidazole 500mg), both three times a day for one week.

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.

Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is Omeprazole 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age >60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Omeprazole 20mg once daily.

Treatment of reflux oesophagitis

The recommended dose is Omeprazole 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

In patients with severe oesophagitis Omeprazole 40mg once daily is recommended and healing is usually achieved within eight weeks.

Long-term management of patients with healed reflux oesophagitis

For the long-term management of patients with healed reflux oesophagitis the recommended dose is Omeprazole 10mg once daily. If needed, the dose can be increased to Omeprazole 20-40mg once daily.

Treatment of symptomatic gastro-oesophageal reflux disease

The recommended dose is Omeprazole 20mg daily. Patients may respond adequately to 10mg daily, and therefore individual dose adjustment should be considered.

If symptom control has not been achieved after four weeks treatment with Omeprazole 20mg daily, further investigation is recommended.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated. The recommended initial dose is Omeprazole 60mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of Omeprazole 20-120mg daily. When dose exceed Omeprazole 80mg daily, the dose should be divided and given twice daily.

Paediatric population

Children over 1 year of age and ≥10kg

Treatment of reflux oesophagitis / Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease:

The posology recommendations are as follows:

Reflux oesophagitis: The treatment time is 4-8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease: The treatment time is 2–4 weeks. If symptom control has not been achieved after 2–4 weeks the patient should be investigated further.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H. pylori:

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

Special populations

Renal impairment

Dose adjustment is not needed in patients with impaired renal function (see section 5.2).

Hepatic impairment

In patients with impaired hepatic function a daily dose of 10–20mg may be sufficient (see section 5.2).

Elderly (>65 years old)

Dose adjustment is not needed in the elderly (see section 5.2).

Method of administration

It is recommended to take Omeprazole capsules in the morning, swallowed whole with half a glass of water. The capsules must not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food

Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g. fruit juice or applesauce, or in non-carbonated water. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water.

Alternatively patients can suck the capsule and swallow the pellets with half a glass of water. The enteric coated pellets must not be chewed.

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.

The symptoms described have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.

Shelf life

Aluminium-aluminium blister: 3 years.

HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant: 3 years. Use within 3 months of opening.

Store below 25°C.

Aluminium/Aluminium blister pack: Store in the original package to protect from moisture.

HDPE tablet container: Keep the bottle tightly closed to protect from moisture.

OPA/Aluminium/PVC: Aluminium blister; OPA/Aluminium/PVC: PET/Aluminium blister:

Pack sizes: 7’s, 10’s, 14’s, 15’s, 20’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s

HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant:

Pack size: 30, 90

Not applicable.