Index of drugs

Table. enteric-coated 20 mg. Adults and adolescents aged 12 and over: othe manifest form of gastroesophageal reflux disease; long-term treatment and prevention of recurrent reflux oesophagitis.Adults: prevention of gastroduodenal ulceration caused by the use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk who require long-term use of NSAIDs.Table. enteric 40 mg.Adults and adolescents aged 12 and above: reflux oesophagitis.Adults: eradicationHelicobacter pylori in combination with appropriate antibiotics in patients with peptic ulcer diseaseH. pylori; cstomach ulcer and / or duodenal ulcer; Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.

1 tabl enteric contains 20 mg or 40 mg pantoprazole. The drug contains soya lecithin.

Proton pump inhibitor (H⁺/ K⁺ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of hydrochloric acid, both basic and stimulated (regardless of the stimulating factor of this secretion). Pantoprazole quickly absorbs from the gastrointestinal tract, reaching C_max during about 2-2.5 hours. Bioavailability is about 77%; binding to plasma proteins - 98%. It is metabolized in the liver. The major metabolic pathway is demethylation by CYP2C19 followed by conjugation with sulfate, other metabolic pathways include oxidation by CYP3A4. The metabolites of pantoprazole are mainly excreted via the kidneys (approximately 80%); the rest is excreted with faeces. T_0,5 pantoprazole in the final phase of elimination is about 1 hour; T_0,5 the main metabolite - about 1.5 hours.

Hypersensitivity to Pantoprazole, substituted benzimidazole or to any of the excipients or substance used in combination therapy.

Patients with severe hepatic impairment should be monitored regularly for liver enzymes in the blood, especially if pantoprazole is used for a long time. When increased hepatic enzyme activity occurs, pantoprazole should be discontinued. Do not use in combination treatment for eredicationH. pylori in patients with moderate and severe hepatic impairment and in patients with impaired renal function. For combination therapy, please refer to the appropriate SPC for combination medicines. The use of pantoprazole in the prevention of gastric and duodenal ulcers caused by NSAIDs should be limited to patients who require continuous treatment with NSAIDs whose risk of developing gastrointestinal complications is increased (risk factors: age> 65 years, gastric or duodenal ulcers or bleeding with the upper part of the digestive tract). In patients with suspected or diagnosed peptic ulcer disease, as well as any disturbing symptoms (eg, significant unintentional weight loss, recurrent vomiting, swallowing difficulties, bloody vomiting or tarry stools, anemia), the cancerous background of the disease should be excluded, as treatment pantoprazole can relieve the symptoms of cancer and delay its diagnosis. Patients who have been on treatment for a long time (especially if the treatment lasts for more than a year) should remain under regular medical supervision. Treatment with pantoprazole may slightly increase the risk of gastrointestinal infections with such bacteria asSalmonella spp., Campylobacter spp.and C. difficile.Pantoprazole may reduce the absorption of vitamin B₁₂ (cyanocobalamin) due to hypo or achlorhydria; this should be taken into account during long-term treatment of patients with reduced vitamin B stores₁₂ or risk factors favoring the reduction of its absorption or in case of clinical symptoms. In patients treated with pantoprazole for at least 3 months(in most cases for a year) severe hypomagnesaemia was noted; in patients who are envisaged for long-term treatment or who are taking proton pump inhibitors concomitantly with Digoxin or hypomagnesaemic agents (eg diuretics), Magnesium determination should be considered before starting treatment with pantoprazole and periodically during treatment. Proton pump inhibitors can increase the overall risk of fractures by 10-40%; Patients at risk of osteoporosis should receive care in accordance with current clinical guidelines, and provide adequate amounts of vitamin D and calcium. In case of skin lesions, especially in places exposed to sunlight, with joint pain, consideration should be given to discontinuation of pantoprazole (possibility of subacute cutaneous form of SCLE Lupus Erythematosus, SCLE as a result of earlier IPP treatment may increase the risk of SCLE as a result of treatment with other IPP) . The use of pantoprazole with atazanavir is not recommended (reduction of atazanavir exposure). The drug should not be used in children <12 years (no tests). Due to the content of soya lecithin, the drug should not be used in patients with hypersensitivity to peanut or soya.

Do not use during pregnancy unless clearly necessary. The penetration of pantoprazole into breast milk has been found. Therefore, the decision whether to continue / stop breast-feeding or to continue / stop taking the drug should be taken taking into account the benefits for the child resulting from breastfeeding and the benefits for a woman resulting from treatment with pantoprazole.

Uncommon: sleep disturbances, headache, dizziness, diarrhea, nausea, vomiting, abdominal fullness, bloating, constipation, dry mouth, epigastric pain and discomfort, increased liver enzymes (transaminases, GGT), rash dermatitis, eczema, skin eruptions, pruritus, hip bone refraction, carpal bones, spine, weakness, tiredness and malaise. Rarely: hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidemias and increased lipids (triglycerides, cholesterol), changes in body weight, depression (and all agitations), visual disturbances, blurred vision, increased bilirubin, urticaria, angioneurotic edema, joint pain, muscle pain, gynecomastia, increased body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, confusion (and all agitations). Frequency unknown: hyponatraemia, hypomagnesaemia, hallucinations, confusion (especially in predisposed patients, as well as worsening of these symptoms in the event of their previous occurrence), liver cell damage, jaundice, hepatic cell failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light, subacute cutaneous form of systemic lupus erythematosus, interstitial nephritis.

Orally. Adults and adolescents aged ≥12 years. Symptomatic form of gastroesophageal reflux disease: 1 tabl. 20 mg once a day. Symptoms usually disappear after 2-8 weeks of use. When the symptoms resolve, you can control the recurrence of the disease by using "on demand" 20 mg of pantoprazole per day. If, despite the use of "on demand" pantoprazole, the symptoms do not improve, re-use of pantoprazole may be considered.Long-term treatment and prevention of recurrent reflux oesophagitis: maintenance dose 1 tablet 20 mg once a day. If the disease recurs, the dose can be increased to 1 tablet. 40 mg daily. After the recurrence of symptoms disappears, the dose can be reduced again to 1 tablet. 20 mg daily.Reflux oesophagitis: 1 tabl. 40 mg once a day. In individual cases, the dose may be doubled (increased to 80 mg / day), especially when there is no response to other treatment. Cure reflux oesophagitis usually requires 4-8 weeks.Adults.Prevention of duodenal ulceration caused by useNSAIDs in patients at increased risk, uwhich long-term NSAID treatment is necessary: 1 tabl. 20 mg once a day.eradicationH. pylori in combination with two appropriate antibiotics. Local official guidelines (eg national recommendations) regarding bacterial resistance and the proper use and prescription of antimicrobial agents should be considered. Depending on the pattern of resistance for eradicationH. pylori the following combination treatment regimens are recommended: a) 1 tabl. 40 mg pantoprazole twice daily + 1000 mg Amoxicillin twice daily + 500 mg Clarithromycin twice daily; b) 1 tabl. 40 mg pantoprazole twice daily + 400-500 mg Metronidazole (or 500 mg tinidazole) twice daily + 500 mg clarithromycin twice daily; c) 1 tabl. 40 mg pantoprazole twice daily + 1000 mg amoxicillin twice daily + 400-500 mg metronidazole (or 500 mg tinidazole) twice daily. In combined treatment to eradicate the infectionH. pylori the second enteric tablet formulation should be taken 1 h before supper. Combination therapy is usually used for 7 days and may be extended for a further 7 days, up to a total treatment duration of up to 2 weeks. If further treatment with pantoprazole is indicated for healing of ulcers, dose recommendations for gastric and duodenal ulcers should be considered. If it is not possible to use combination therapy, e.g. studies have shown that the patient is not a carrierH. pylori, in the case of pantoprazole monotherapy, the following guidelines apply.Treatment of peptic ulcer: 1 tabl. 40 mg once a day. In individual cases, the dose may be doubled (increased to 80 mg / day), especially when there is no response to other treatment. The period of 4-8 weeks is usually necessary to cure stomach ulcers.Treatment of duodenal ulcer: 1 tabl. 40 mg once a day. In individual cases, the dose may be doubled (increased to 80 mg / day), especially when there is no response to other treatment. Duodenal ulcers usually heal within 2-4 weeks.Zollinger-Ellison syndrome and other disease states resulting from excessive secretion: initially 80 mg per day (2 tables of 40 mg), then the dose can be increased or reduced as needed based on measurements of gastric acid secretion. Daily doses> 80 mg should be given in 2 divided doses. A transient dose increase> 160 mg is possible, but this dose should not be administered longer than is necessary to achieve adequate control of acid secretion. The duration of treatment for Zollinger-Ellison syndrome and other conditions caused by hypersecretion is uncertain and should be adapted to clinical needs.Special groups of patients. No dose adjustment is necessary in elderly patients or in patients with renal impairment (do not use in combination therapy for eradication) H. pylori in patients with impaired renal function). In patients with severe hepatic impairment, a daily dose of> 20 mg should not be used (do not use in combination therapy for eradication) H. pylori in patients with moderate and severe hepatic impairment).Way of giving. Table. should be swallowed whole 1 hour before a meal with water. The tablets should not be chewed or crushed.