Index of drugs

Adults. Treatment of duodenal ulcer. Prevention of duodenal ulcer recurrence. Treatment of stomach ulcers. Prevention of recurrent stomach ulcers. In combination with appropriate antibiotics, eradication therapyHelicobacter pyloriin peptic ulcer disease. Treatment of gastric and duodenal ulcers associated with NSAIDs. Prevention of gastric and duodenal ulcers associated with NSAIDs in patients at risk of developing them. Treatment of reflux oesophagitis. Long-term supportive care for patients after healing of reflux oesophagitis. Treatment of symptomatic gastroesophageal reflux disease. Treatment of Zollinger-Ellison syndrome.Children> 1 year and weighing ≥ 10 kg. Treatment of reflux oesophagitis. Symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease.Children and adolescents aged> 4 years. In combination with antibiotics for the treatment of duodenal ulcer caused byH. pylori.

1 capsule contains 20 mg of Omeprazole (and 7.920 mg of lactose and 162.626 mg of sucrose).

A specific proton pump inhibitor (H⁺/ K⁺ ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of hydrochloric acid, both basal and after stimulation, regardless of the type of stimulant. After oral administration of omeprazole once a day, fast and effective inhibition of gastric acid secretion takes place 24 hours a day, with the maximum effect being achieved after 4 days. After this time of omeprazole 20 mg per day in patients with duodenal ulcer, the 24-hour gastric acidity is reduced by an average of about 80%. Absorption of omeprazole is rapid, maximal plasma concentration occurs approximately 1-2 hours after administration. Plasma proteins are 97% bound. Omeprazole is completely metabolised, mainly by the CYP2C19 enzyme. It is excreted in the form of metabolites, mainly in the urine and to a small extent with faeces. T_0,5 is <1 h.

Hypersensitivity to the active substance, substituted benzimidazoles or any of the excipients. Do not use with nelfinavir.

In case of any disturbing symptoms (eg significant unintentional weight loss, recurrent vomiting, difficulty swallowing, bloody vomiting or tarry stool), as well as in the case of suspicion or presence of gastric ulcer, the presence of neoplastic lesions should be excluded, because treatment with the preparation may relieve symptoms and delay the diagnosis. Omeprazole may reduce the absorption of vitamin B₁₂due to hypo- or achlorhydria, which should be taken into account in patients with vitamin B deficiency₁₂ in the body and in case of risk factors that reduce the absorption of vitamin B₁₂ during long-term treatment. For patients presumed long-term or taking proton pump inhibitors together with Digoxin or other drugs that may cause hypomagnesaemia (e.g. diuretics), consideration should be given to measuring Magnesium in the blood prior to initiating treatment with proton pump inhibitors for a periodic period of during treatment. Proton pump inhibitors, especially at high doses and in long-term therapy (> 1 year), may slightly increase the risk of hip fractures, carpal bones and spine, especially in elderly patients or in patients with known risk factors. Patients at risk for osteoporosis should receive care in accordance with current clinical guidelines and should take the appropriate dose of vitamin D and calcium. The use of atazanavir is not recommended - if such combination therapy is necessary, close clinical monitoring (eg viral load) is recommended with an increase of atazanavir to 400 mg with 100 mg ritonavir; do not exceed the 20 mg dose of omeprazole per day. Co-administration of omeprazole and Clopidogrel is not recommended.Some children with chronic conditions may need long-term treatment, but it is not recommended. In the case of long-term therapy, particularly used for more than a year, patients should remain under regular control. Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections with bacteria such asSalmonella andCampylobacter. Due to the lactose and sucrose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose, and in patients with fructose intolerance or sucrase-isomaltase deficiency.

The preparation can be used during pregnancy. Omeprazole passes into breast milk, but there is no risk of adverse effects on the child when using the drug at therapeutic doses.

Common: headache, diarrhea, constipation, abdominal pain, nausea, vomiting, bloating. Uncommon: insomnia, dizziness, paresthesia, drowsiness, increased liver enzymes, dermatitis, pruritus, rash, urticaria, hip fracture, carpal or spinal bones, malaise, peripheral edema. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (eg fever, angioneurotic edema and anaphylactic reaction / shock), hyponatremia, agitation, confusion, depression, dysgeusia, blurred vision, bronchospasm, dry mouth, oral mucositis, gastrointestinal candidiasis, hepatitis with jaundice and without jaundice, alopecia, hypersensitivity to light, joint or muscle pain, 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, muscle weakness, gynecomastia. Not known: hypomagnesemia, microscopic colitis. The profile of adverse reactions in children was the same as in adults, both during short-term and long-term treatment.

Orally.Adults. Treatment of duodenal ulcer20 mg once daily for 2-4 weeks; in patients with refractory ulcer disease, a dose of 40 mg once daily for 4 weeks is used.Prevention of duodenal ulcer recurrence (uninfected patientsH. pylori or when eradicationH. pylori not possible): usually 20 mg once a day; in some patients a dose of 10 mg may be sufficient; if the therapy fails, the dose may be increased to 40 mg.Treatment of stomach ulcers20 mg once a day for 4-8 weeks; in patients with peptic ulcer disease refractory to treatment, a dose of 40 mg once daily for 8 weeks is used.Prevention of recurrent stomach ulcers20 times daily, if necessary, the dose may be increased to 40 mg once a day.H. pylori eradication in patients with peptic ulcer disease (patient's individual tolerance of the drug should be taken into account, as well as national, regional and local data on antimicrobial resistance, as well as treatment guidelines): recommended diagrams - 20 mg Omeprazole, 500 mg Clarithromycin, 1000 mg Amoxicillin, administered twice daily for 1 week .; or 20 mg of omeprazole, 250 mg of Clarithromycin (alternatively 500 mg), 400 mg of Metronidazole (alternatively 500 mg or 500 mg of tididazole), administered twice daily for 1 week; or 40 mg omeprazole once daily, 500 mg Amoxicillin and 400 mg metronidazole (or 500 mg or 500 mg tinidazole) 3 times daily for 1 week; if infection persistsH. pylori the treatment regimen can be repeated.Treatment of gastric and duodenal ulcers associated with the use of NSAIDs20 mg once a day for 4-8 weeksPrevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients with an increased risk of their occurrence: in patients at risk (age> 60 years, history of gastric and duodenal ulceration, upper gastrointestinal bleeding) 20 mg once daily.Treatment of reflux oesophagitis20 mg once a day for 4-8 weeks; in patients with severe reflux oesophagitis, 40 mg once daily for 8 weeks are used.Long-term maintenance treatment in patients with healing reflux oesophagitis: 10 mg once a day, if necessary 20-40 mg once a day.Treatment of symptomatic gastroesophageal reflux disease20 mg once a day, in some patients 10 mg daily; if the symptoms do not improve after 4 weeks of treatment with 20 mg daily, further diagnostic tests are recommended.Treatment of Zollinger-Ellison syndrome: individual dosing, treatment should continue until there are clinical indications, the recommended starting dose is 60 mg per day and the maintenance dose 20-120 mg per day; doses higher than 80 mg should be administered in divided doses.Children > 1 year and about ≥10 kg.Treatment of reflux oesophagitis and symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease: ≥1 yo, mc. 10-20 kg - 10 mg once a day, if necessary 20 mg per day; ≥2 years, mc. > 20 kg - 20 mg once a day, if necessary 40 mg daily; the duration of treatment in reflux oesophagitis is 4-8 weeks, and the symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease lasts 2-4 weeks. Children> 4 years and adolescents.Treatment of duodenal ulcers caused by infectionH. pylori (follow national, regional and local guidelines for antimicrobial resistance, duration of treatment, and appropriate use of antimicrobial agents): 15-30 kg - combination therapy 10 mg omeprazole, 25 mg / kg Amoxicillin, 7.5 mg / kg clarithromycin, administered twice daily for 1 week; mc. 31-40 kg - combination therapy with 20 mg omeprazole, 750 mg amoxicillin, 7.5 mg / kg clarithromycin, administered twice daily for 1 week; mc. > 40 kg - combination therapy with 20 mg of omeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, administered twice daily for 1 week; duration of treatment is 1-2 weeks; treatment should be supervised by a specialist doctor.Special groups of patients: no dosage adjustment is necessary for elderly patients and patients with renal impairment. In patients with hepatic impairment, a dose of 10-20 mg may be sufficient.Way of giving. Capsules are recommended to be taken in the morning, preferably during a meal. Swallow whole with a glass of water. The capsules must not be chewed or crushed. Patients with swallowing disorders and children who are able to drink or swallow semi-solid food: open the capsule and swallow its contents with half a glass of water or mix the contents of the capsule with a slightly acidic liquid eg fruit juice, apple sauce or still water (the suspension should be drink up to 30 minutes after preparation, mix it immediately before drinking and after drinking it, drink half a glass of water). Alternatively, patients can suck the capsule and swallow the pellets with half a glass of water without chewing.