OMEPRAZOLE

Posology Adults Treatment of duodenal ulcers The recommended dose in patients with an active duodenal ulcer is 20 mg omeprazole 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 40 mg omeprazole 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 20 mg omeprazole once daily. In some patients a daily dose of 10 mg may be sufficient. In case of therapy failure, the dose can be increased to 40 mg.

Treatment of gastric ulcers The recommended dose is 20 mg omeprazole 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 40 mg omeprazole 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 20 mg omeprazole once daily.

If needed the dose can be increased to 40 mg omeprazole 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 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or • Omeprazole 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily for one week or • Omeprazole 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole 500 mg), 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 20 mg omeprazole 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 20 mg omeprazole once daily.

Treatment of reflux esophagitis The recommended dose is 20 mg omeprazole 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 esophagitis 40 mg omeprazole once daily is recommended and healing is usually achieved within eight weeks. Long-term management of patients with healed reflux esophagitis For the long-term management of patients with healed reflux esophagitis the recommended dose is 10 mg omeprazole once daily.

If needed, the dose can be increased to 20-40 mg omeprazole once daily. Treatment of symptomatic gastro-esophageal reflux disease The recommended dose is 20 mg omeprazole daily. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.

If symptom control has not been achieved after four weeks treatment with 20 mg omeprazole 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 60 mg omeprazole 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 20-120 mg omeprazole daily.

When dose exceed 80 mg omeprazole daily, the dose should be divided and given twice daily. Paediatric population Children over 1 year of age and ≥10 kg Treatment of reflux esophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease.

The posology recommendations are as follows:

Age Weight Posology ≥ 1 year of age 10-20 kg 10 mg once daily. The dose can be increased to 20 mg once daily if needed. ≥ 2 years of age > 20 kg 20 mg once daily. The dose can be increased to 40 mg once daily if needed.

Reflux esophagitis:

The treatment time is 4–8 weeks. Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal 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.

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. 5 mg/kg body weight are all administered together two times daily for one week 31-40 kg Combination with two antibiotics: omeprazole 20 mg, amoxicillin 750 mg and clarithromycin […]

Summary of the safety profile The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. 4). Tabulated list of adverse reactions The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing.

None was found to be dose-related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).

Frequency categories are defined according to the following convention:

Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data). g. 4); severe hypomagnesaemia may result in hypocalcaemia.

Hypomagnesaemia may also be associated with hypokalaemia. 4) Rare: Arthralgia, myalgia Very rare: Muscular weakness Renal and urinary disorders Rare: Tubulointerstitial nephritis (with possible progression to renal failure) Reproductive system and breast disorders Very rare: Gynaecomastia General disorders and administration site conditions Uncommon: Malaise, peripheral oedema Rare: Increased sweating Paediatric population The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease.

There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive esophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment.

There are no long term data regarding the effects of omeprazole treatment on puberty and growth. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

5). g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded. Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.

This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered.

5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged. Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like omeprazole for at least three months, and in most cases for a year.

Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which can be life- threatening or fatal, have been reported very rarely and rarely, respectively in association with omeprazole treatment.

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.

Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Omeprazole 10 mg gastro-resistant capsules, hard.

SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. 8). Acute tubulointerstitial nephritis can progress to renal failure. Omeprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated.

Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Some children with chronic illnesses may require long-term treatment although it is not recommended. 1). As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Sucrose This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

1. 5).