OMEPRAZOLE

Omeprazole 2mg/ml Oral Suspension is suitable for doses of ≤ 15mg. For doses of 20mg or greater, Omeprazole 4mg/ml Oral Suspension is suitable. Posology in adults Treatment of duodenal ulcers The recommended dose in patients with an active duodenal ulcer is Omeprazole 20 mg 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 40 mg 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 20 mg 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 Omeprazole 20 mg 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 40 mg 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 20 mg once daily.

If needed the dose can be increased to Omeprazole 40 mg 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.

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. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders Rare: Hyponatraemia Not known: Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia.

Hypomagnesaemia may also be associated with hypokalaemia. 4) Musculoskeletal and connective tissue disorders Uncommon: Fracture of the hip, wrist or spine 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.

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.

g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during 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.

1. 5).