Index of drugs

Adults and adolescents aged ≥ 12 years: reflux oesophagitis. Adults: eradicationHelicobacter pylori in combination with appropriate antibiotic therapy in patients with peptic ulcer diseaseH. pylori; peptic ulcer of the stomach and duodenum; Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.

1 tabl enteric contains 40 mg of pantoprazole. The product contains maltitol and soya lecithin.

A drug that inhibits the secretion of hydrochloric acid in the parietal cells of the stomach as a result of selective blocking of H activity⁺/ K⁺-ATP-azy (the so-called proton pump). The effect of the drug depends on the dose and leads to inhibition of both basal secretion and stimulated secretion (regardless of the type of stimulus). It reduces the acidity of gastric contents and, secondarily, in a reversible manner, increases gastrin secretion to an extent proportional to the decrease in acidity. After oral administration, Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum blood concentration in 2-2.5 hours. The bioavailability is about 77%, the food does not reduce the bioavailability, it can only affect the delay of the drug. About 98% is bound to plasma proteins. Pantoprazole is metabolized in the liver, excreted in approximately 80% by the kidneys in the form of metabolites, the remaining part is excreted in the faeces. T_0,5 is about 1 hour.

Hypersensitivity to the active substance, substituted benzimidazoles, soybean oil (peanuts or soya) or to any of the excipients or preparations used in combination therapy.

Do not use in children under 12 years of age due to insufficient data on the safety and efficacy of therapy in this age group. The use of pantoprazole as a measure to prevent gastric and duodenal ulcers induced by NSAIDs should be limited to patients who require continuous NSAID treatment and are at risk of gastrointestinal complications. The risk should be assessed according to individual risk factors, eg older age (> 65 years), a positive history of gastric or duodenal ulceration or upper gastrointestinal bleeding. In patients with severe hepatic impairment, especially during long-term treatment, liver enzymes should be monitored. If their concentration increases, treatment should be discontinued. During long-term treatment (> 1 year), patients should be covered by regular medical supervision. If the symptoms of the disease persist despite adequate treatment, additional tests should be considered. In patients with Zollinger-Ellison syndrome other conditions associated with excessive acid secretion, pantoprazole may reduce the absorption of vitamin B₁₂ following hypo- or achlorhydria. This should be taken into account in patients with reduced stocks or risk factors for decreased vitamin B absorption₁₂ in the case of long-term treatment or when specific clinical symptoms occur. Treatment with pantoprazole may lead to a slight increase in the risk of food-borne infections caused bySalmonella spp. andCampylobacter spp.. Co-administration with atazanavir is not recommended. Due to the content of maltitol, the preparation should not be used in patients with hereditary fructose intolerance.

Do not use during pregnancy unless clearly necessary. Pantoprazole is excreted in human milk; during breastfeeding, the benefits of breastfeeding and the benefits for the mother due to the use of pantoprazole should be considered.

Uncommon: sleep disturbances, headache, dizziness, diarrhea, nausea, vomiting, abdominal fullness, constipation, dry mouth, epigastric pain and discomfort, increased liver enzymes, rash, eczema, eruptions, pruritus , asthenia, weakness, tiredness and malaise.Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidaemia and increased lipid levels, change in body weight, depression (and all agitations), blurred vision, blurred vision, increased bilirubin, urticaria, angioneurotic edema, arthralgia, muscle pain , gynecomastia, elevated body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, confusion (and all agitations). Unknown: hyponatraemia, hallucinations, confusion (especially in susceptible patients as well as the severity of these symptoms in the event of their previous occurrence), liver cell damage, jaundice, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light interstitial nephritis.

Orally.Adults and adolescents aged ≥12 years. Reflux oesophagitis: 40 mg once a day. In individual cases the dose can be doubled up to 80 mg daily, especially when there is no response to other treatments. The period of application is 4 weeks, if it is not sufficient to cure it, it should be extended for another 4 weeks.Adults eradicationHelicobacter pylori in combination with the appropriate antibiotics: 40 mg twice daily (second tablet of pantoprazole should be taken 1 hour before supper) for 7 days simultaneously with antimicrobial treatment (amoxicillin 1 g 2 times daily and Clarithromycin 500 mg twice daily or clarithromycin 250-500 mg 2 times per day) daily and Metronidazole 400-500 mg (or tididazole 500mg) twice daily or Amoxicillin 1g twice daily and metronidazole 400-500 mg (or tidanidazole 500mg) twice daily, if necessary, treatment can be continued for another 7 days If further treatment with pantoprazole is indicated to completely cure the ulcer, consideration should be given to the dosage recommended for the treatment of gastric and duodenal ulcer.Treatment of peptic ulcer: 40 mg daily; in individual cases when there is no response to 80 mg treatment per day. Usually healing occurs within 4 weeks; if this period is insufficient, the treatment should be prolonged for another 4 weeks.Treatment of duodenal ulcer: 40 mg daily; in individual cases when there is no response to 80 mg treatment per day. Usually healing occurs within 4 weeks; if this period is insufficient, the treatment should be prolonged for another 4 weeks. Zollinger-Ellison syndrome and other diseases associated with excessive secretion of hydrochloric acid: initially 80 mg per day, then the dose can be increased or decreased based on the results of gastric acid secretion tests. Daily doses greater than 80 mg daily administered in two doses. It is possible to periodically use a dose of more than 160 mg, but it should not be used longer than necessary to achieve adequate suppression of gastric acid secretion. The duration of treatment is not limited and should be adapted to clinical symptoms.
No dose adjustment is required in patients with impaired renal function or elderly patients. In patients with severe hepatic impairment, a dose greater than 20 mg should not be used. Table. 40 mg do not use in combination therapy in eradicationH. pylori in patients with moderate and severe hepatic impairment and in patients with impaired renal function due to a lack of data on safety and efficacy.
The tablets should be taken 1 hour before a meal, swallowed whole and washed down with water. The tablets should not be chewed, chewed or crushed.