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, NSAID-associated gastric and duodenal 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 gastro-esophageal 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. Can be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Contra-indications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients. Omeprazole must not be used with nelfinavir. Excipient warnings: contains sodium, potassium, sodium methyl para hydroxybenzoate, sodium benzoate and maltitol. Drug interactions: Active substances with pH dependent absorption. Not recommended: atazanavir, digoxin, clopidogrel, posaconazole, erlotinib, ketoconazole, itraconazole and active substances metabolised by or inhibitors/inducers of CYP2C19 or CYP3A4. Unkown mechanism: Saquinavir/ritonavir, tacrolimus, methotrexate. Special Warnings and Precautions for use: malignancy, reduced vitamin B12 absorption, severe hypomagnesaemia, increased risk of bone fracture, subacute cutaneous lupus erythematosus (SCLE), gastrointestinal infections may occur, treatment should be stopped for at least 5 days before CgA measurement. Fertility, Pregnancy and Lactation: Omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Animal studies do not indicate effects on fertility. Effects on Ability to Drive and Use Machines: Is not likely to affect the ability to drive or use machines. Undesirable Effects: Adults and children: Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps. Uncommon: Insomnia, dizziness, paraesthesia, somnolence, vertigo, increased liver enzymes, dermatitis, pruritus, rash, urticaria, fracture of the hip, wrist or spine, malaise, peripheral oedema. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions, hyponatraemia, agitation, confusion, depression, taste disturbance, blurred vision, bronchospasm, dry mouth, stomatitis, gastrointestinal candidiasis, hepatitis, alopecia, photosensitivity, arthralgia, myalgia, interstitial nephritis, increased sweating. Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, hepatic failure, encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscular weakness, gynaecomastia. Not known: hypomagnesaemia, hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia, microscopic colitis, subacute cutaneous lupus erythematosus. Overdose: The symptoms described have been transient, and no serious outcome has been reported. Treatment is symptomatic. Shelf Life and storage: Dry Powders: 24 months. Constituted suspension: 28 days. The constituted suspension should be stored in a refrigerator (2°C - 8°C). Store in the original container in order to protect from light. Keep the bottle tightly closed. For up to 2 days it may be stored below 25°C. Dry Powders: Do not store above 25°C. Store in the original foil pouch in order to protect from light and moisture. Legal Category: POM Pack Size and NHS Price: 2mg/ml x 75ml - £112, 4mg/ml x 75ml - £216. 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: January 2020.
Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard