CLYOMEP

Posology Oesophageal reflux disease including reflux oesophagitis:

The usual dosage is 20mg omeprazole once daily. The majority of patients are healed after 4 weeks. Symptom relief is rapid. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.

Omeprazole has also been administered in a dose of 40mg once daily in patients with reflux oesophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can continue at a dosage of 20mg once daily.

Acid reflux disease:

For long-term management 10mg omeprazole once daily is recommended, increasing to 20mg if symptoms return.

Duodenal and benign gastric ulcers:

The usual dose is 20mg omeprazole once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40mg omeprazole daily.

A dosage of 20mg omeprazole once daily is recommended for a long-term therapy in patients with a history of recurrent duodenal ulcer. For prevention of relapse in patients with duodenal ulcer the recommended dose is 10mg omeprazole once daily, increasing to 20mg once daily, if symptoms return.

The following groups are at risk from recurrent ulcer relapse: younger patients (< 60 years), those whose symptoms persist for more than 1 year and smokers, those with Helicobacter pylori infection. These patients will require initial long-term therapy with 20mg omeprazole once daily, reducing to 10mg once daily, if necessary.

Acid-related dyspepsia:

The usual dosage is omeprazole 10mg or 20mg once daily for 2-4 weeks depending on the severity and persistence of symptoms. For the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions: the recommended dosage of omeprazole is 20mg once daily.

Symptom resolution is rapid and in most patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment. For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment: the only recommended dosage of omeprazole is 20mg once daily.

Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease:

Omeprazole is recommended at a dose of 40mg once daily or 20mg twice daily in association with antimicrobial agents.

Prophylaxis of acid aspiration:

For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is 40mg on the evening before surgery followed by 40mg 2-6 hours prior to surgery.

Zollinger-Ellison syndrome:

The recommended initial dosage is 60 mg omeprazole once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120mg daily.

With doses above 80mg daily, the dose should be divided and given twice daily. A limited duration of the omeprazole intake is not foreseen for the treatment of the Zollinger-Ellison syndrome. Treatment should be continued under specialist supervision as long as clinically indicated.

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Paediatric population:

Experience of the use of omeprazole in children is limited. 4 mg/kg, to a maximum 40mg/day, for 4- 12 weeks. Data suggest that approximately 65% of children will experience pain relief with this dose regimen. Treatment should be initiated by a hospital based paediatrician.

2). 2). Method of Administration For reasons of improved absorption, the capsules are to be swallowed whole together with some liquid before meals.

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. The following have been identified or suspected as adverse events in 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:

The following definitions of frequencies are used: Very common (≥ 1/10), Common ≥ 1/100 to < 1/10 (1-10% of patients) Uncommon ≥ 1/1000 to < 1/100 Rare ≥1/10,000 to < 1/1000 Very rare <1/10,000 Not known (cannot be estimated from the available data).

g. 4). 4) Renal and urinary disorders Rare Interstitial nephritis Reproductive system and breast disorders Very rare Gynaecomastia Rare Impotence 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 oesophagitis 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.

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.

Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. 1). 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. Some children with chronic illnesses may require long-term treatment although it is not recommended. Omeprazole gastro-resistant tablets contain sucrose.

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, sucrose-isomaltase insufficiency, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Severe hypomagnesaemia has been reported in patients treated with 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), health care 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.

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.

SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. 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.

1. When gastric ulcer is suspected, the possibility of a malignancy should be excluded before treatment with omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis. 5).