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. 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. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable Effects: Common reactions are presented below and refer the SmPC for details of other adverse reactions: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, and fundic gland polyps (benign). Pack Size and NHS Price: 2mg/ml x 75ml - £120, 4mg/ml x 75ml - £224. 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: December 2022.
.
|
Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard |