Abbreviated Prescribing Information: Omeprazole 2mg/ml and 4mg/ml, Powder for Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: The reconstituted suspension will be a white / off-white / brownish suspension containing 2mg/ml or 4mg/ml omeprazole. Therapeutic Indications: Adults: Treatment of duodenal ulcers, gastric ulcers, NSAID-associated gastric and duodenal ulcers, reflux esophagitis, symptomatic gastro-esophageal reflux disease, prevention of relapse of duodenal ulcers, gastric ulcers, in combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease, long-term management of patients with healed reflux esophagitis. Paediatric use: Children over 1 month of age: treatment of reflux esophagitis, symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease. Children over 4 years of age and adolescents: In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori. Posology and Method of Administration: Adults: Treatment and prevention of relapse of duodenal ulcers, gastric ulcers: 10 – 40mg once daily. H. pylori eradication 20 – 40mg once or twice daily + suitable antibiotic for one week, which may be repeated. Treatment and prevention of NSAID-associated gastric and duodenal ulcers: 20mg once daily, for 4 weeks, which may be repeated. Treatment of reflux esophagitis: 20mg once daily for 4 weeks, which may be repeated. Severe esophagitis 40mg once daily for 8 weeks. Long-term management of patients with healed reflux esophagitis: 10 – 40mg once daily. Treatment of symptomatic gastro-esophageal reflux disease: 10-20mg daily. Paediatric population: 1 month to 1 year: 1mg/kg once daily.1 year 10 – 20mg once daily. 2 years of age 20 – 40mg once daily. Reflux esophagitis: Treatment 4 – 8 weeks. Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease: Treatment 2 – 4 weeks. Children over 4 years of age and adolescents: Treatment of duodenal ulcer caused by H. pylori: 10 – 20mg depending on weight + suitable antibiotic twice daily for one week. Special populations: Dose adjustment is not needed in patients with impaired renal function. In patients with impaired hepatic function a daily dose of 10 – 20mg may be sufficient. Dose adjustment is not needed in the elderly. Method of administration: Oral suspension should be taken on an empty stomach, at least 30 minutes before a meal. Omeprazole can be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients. Omeprazole must not be used with nelfinavir. Special Warnings and Precautions for use: Caution should be exercised when used as Omeprazole may alleviate symptoms of malignancy and delay diagnosis. Concomitant use with atazanavir is not recommended. Omeprazole may reduce the absorption of vitamin B12 and the potential for interactions with drugs metabolised through CYP2C19 should be considered. 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. Increased risk of hip, wrist and spine fracture in high doses and over long durations (>1 year) should be considered. Severe cutaneous adverse reactions are reported in association with omeprazole treatment. Treatment should be discontinued in case of suspected acute tubulointerstitial nephritis and subacute cutaneous lupus erythematosus. Omeprazole treatment should be stopped for at least 5 days before Increased Chromogranin measurements. Slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter are associated with proton pump inhibitors. Care should be exercised in patients with reduced kidney function or patients on a controlled potassium diet as this medicine contains 54.3 mg (1.39 mmol) potassium per ml or 271.5 mg (6.95 mmol) of potassium per 5 ml dose. Allergic reactions may be caused by the excipient sodium methyl para hydroxybenzoate. Patients with fructose intolerance should not take this medicine as it contains maltitol. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. The reported adverse reactions are: Leukopenia, thrombocytopenia, Agranulocytosis, Pancytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Hyponatraemia, Hypomagnesaemia, Hypocalcaemia, Hypokalaemia, Insomnia, Agitation, Confusion, Depression, Aggression, Hallucinations, Headache, Dizziness, Paraesthesia, Somnolence, Taste disturbance, Blurred vision, Vertigo, Bronchospasm, Abdominal pain, Constipation, Diarrhoea, Flatulence, Nausea/Vomiting, Fundic gland polyps (benign), Dry mouth, Stomatitis, Gastrointestinal candidiasis, Microscopic colitis, Increased liver enzymes, Hepatitis with or without jaundice, Hepatic failure, Encephalopathy in patients with pre-existing liver disease, Dermatitis, Pruritus, Rash, Urticaria, Alopecia, Photosensitivity, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Subacute cutaneous lupus erythematosus, Fracture of the hip, wrist or spine, Arthralgia, Myalgia, Muscular weakness, Tubulointerstitial nephritis (with possible progression to renal failure), Gynaecomastia, Malaise, Peripheral oedema, and Increased sweating. Pack Size and NHS Price: Each bottle contains 90ml of oral suspension of which at least 75ml is intended for dosing- 2mg/ml £124.00 & 4mg/ml £234.00. Marketing Authorisation Number: 2mg/ml –PL 34111/0002, 4mg/ml – PL 34111/0003. Marketing Authorisation Holder: Xeolas Pharmaceuticals Limited, Hamilton Building, DCU, Glasnevin, Dublin 9, IRELAND. Date of Preparation: July 2023.
Abbreviated Prescribing Information: Omeprazole 1 mg/ml, Powder for Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: White/off-white/slightly yellow powder, each ml of reconstituted suspension contains 1 mg of omeprazole. Therapeutic Indications: Omeprazole Oral Suspension is indicated for treatment of reflux esophagitis; Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease in children aged 1 – 12 months of age. Posology and Method of Administration: Omeprazole Oral Suspension should be taken on an empty stomach following reconstitution, at least 30 minutes before a meal. The oral suspension should not be mixed or administered with any drinks or foods other than milk. Omeprazole can be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Paediatric population aged 1 month to 12 months: Omeprazole 1 mg/ml oral suspension should be used for patients weighing ≥ 2 kg to ≤ 5 kg. 1 mg/kg body weight once daily is recommended. Individual dose measurements ≤ 2 ml are not indicated. The treatment time is 4-8 weeks for reflux esophagitis and 2–4 weeks for heartburn and acid regurgitation in gastro-esophageal reflux disease. Dose adjustment is not needed in patients with impaired renal function. Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed and concomitant use with nelfinavir. Special Warnings and Precautions for use: Caution should be exercised when used as Omeprazole may alleviate symptoms of malignancy and delay diagnosis. Concomitant use with atazanavir is not recommended. Omeprazole may reduce the absorption of vitamin B12 and the potential for interactions with drugs metabolised through CYP2C19 should be considered. 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. Increased risk of hip, wrist and spine fracture in high doses and over long durations (>1 year) should be considered. Severe cutaneous adverse reactions are reported in association with omeprazole treatment. Treatment should be discontinued in case of suspected acute tubulointerstitial nephritis and subacute cutaneous lupus erythematosus. Omeprazole treatment should be stopped for at least 5 days before Increased Chromogranin measurements. Slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter are associated with proton pump inhibitors. Care should be exercised in patients with reduced kidney function or patients on a controlled potassium diet as this medicine contains 54.3 mg (1.39 mmol) potassium per ml or 271.5 mg (6.95 mmol) of potassium per 5 ml dose. Allergic reactions may be caused by the excipient sodium methyl para hydroxybenzoate. Risk for neonatal jaundice should be considered and patients with fructose intolerance should not take this medicine as it contains maltitol. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice (if relevant): N/A. Legal Category: POM. The reported adverse reactions are: Leukopenia, thrombocytopenia, Agranulocytosis, pancytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Hyponatraemia, Hypomagnesaemia; hypocalcaemia, hypokalaemia, Insomnia, Agitation, confusion, depression, Aggression, hallucinations, Headache, Dizziness, paraesthesia, somnolence, Taste disturbance, Blurred vision, Vertigo, Bronchospasm, Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign), Dry mouth, stomatitis, gastrointestinal candidiasis, Microscopic colitis, Increased liver enzymes, Hepatitis with or without jaundice, Hepatic failure, encephalopathy in patients with pre-existing liver disease, Dermatitis, pruritus, rash, urticaria, Alopecia, photosensitivity, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), Subacute cutaneous lupus erythematosus, Fracture of the hip, wrist or spine, Arthralgia, myalgia, Muscular weakness, Tubulointerstitial nephritis (with possible progression to renal failure), Gynaecomastia, Malaise, peripheral oedema, Increased sweating. Pack Size and NHS Price: Each bottle contains 90ml of oral suspension of which at least 75ml is intended for dosing- £111.00. Marketing Authorisation Number: PL 34111/0005. Marketing Authorisation Holder: Xeolas Pharmaceuticals Limited, Hamilton Building, DCU, Glasnevin, Dublin 9, Ireland. Date of Preparation: [July-2023]