OMEPRAZOLE

Paediatric population Children 1-12 months of age Treatment of reflux esophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease The posology recommendations are as follows*: Age Body weight Posology 1 month to 12 months of age ≤ 10 kg 1 mg/kg body weight once daily.

* *Individual dose measurements ≤ 2 ml are not indicated. *Omeprazole 2 mg/ml oral suspension is available for patients weighing > 5 kg to ≤ 10 kg.

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.

2). Method of administration Omeprazole Oral Suspension should be taken on an empty stomach, at least 30 minutes before a meal. 2). Administer immediately after mixing, check that the mixture is fully administered to the infant, then wait at least 30 minutes before commencing feeding.

The oral suspension should not be mixed or administered with any drinks or foods other than milk as that may affect the effectiveness of the medicine. Precautions to be taken before handling or administering the medicinal product Omeprazole powder for oral suspension requires reconstitution prior to oral administration.

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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.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. 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. Hypomagnesaemia 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. Fracture risk 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.

Severe cutaneous adverse reactions (SCARs) 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.

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. 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.

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. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 95 mmol) of potassium per 5 ml dose.

To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. This medicinal product contains sodium methyl para hydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine contains 5 mg sodium benzoate in each 1 ml. Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

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