Index of drugs

Treatment of duodenal ulcer and / or benign gastric ulcer disease. Treatment and prophylaxis of reflux oesophagitis. Symptomatic treatment of reflux oesophagitis (GORD). Treatment and prevention of benign gastric and duodenal ulceration associated with the treatment of non-steroidal anti-inflammatory drugs (NSAIDs) and alleviation of symptoms in patients requiring continuous treatment with NSAIDs. Treatment of Zollinger-Ellison syndrome. Eradication of bacteriaHelicobacter pylori in combination with appropriate antibiotic therapy and prevention of recurrent peptic ulcers in patients with peptic ulcer diseaseH. pylori.

1 capsule contains 30 mg of lansoprazole; capsules contain sucrose.

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). Lansoprazole is a racemic mixture of two active enantiomers that are biotransformed to an active form in the acidic environment of the parietal cells. Lansoprazole is rapidly inactivated by gastric acid and is therefore administered in the form of pellets with a coating that protects against hydrochloric acid in gelatin capsules. Absorption from the duodenum is fast, C_max occurs after 1.5-2 h. Food reduces the rate of absorption of lansoprazole and reduces the AUC by approx. 50%. It binds 95% to plasma proteins. It is metabolized in the liver, mainly with the participation of CYP2C19, partly CYP3A4. T_0,5 is 1-2 hours. In people with impaired liver function, systemic exposure to lansoprazole is higher.

Hypersensitivity to lansoprazole or other components of the preparation. Do not use with atazanavir.

Use with caution in patients with moderate or severe hepatic impairment. For combination therapy with antibiotics, please refer to the appropriate SmPC for combination medicines. The use of lansoprazole in the prophylaxis of peptic ulcers in patients requiring long-term NSAID therapy should be limited only to high-risk groups, e.g. previous gastrointestinal bleeding, perforation or ulceration, advanced age, concomitant use of drugs known to increase the probability of occurrence side effects of the upper gastrointestinal tract (eg corticosteroids or anticoagulants), coexistence of serious diseases or long-term use of NSAIDs at the largest recommended doses. Before starting treatment, the cancerous background of the disease should be excluded, as treatment with lansoprazole may relieve the symptoms of cancer and delay its diagnosis. Due to limited data on the safety of maintenance treatment for more than 1 year, these patients are recommended to regularly evaluate the effectiveness of treatment and to accurately assess the risks and benefits of treatment. Treatment with lansoprazole may slightly increase the risk of gastrointestinal infections with such bacteria asSalmonella spp.and Campylobacter spp. In patients treated with lansoprazole for at least 3 months (in most cases for one year) severe hypomagnesaemia was reported; 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 prior to initiating lansoprazole therapy and then 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 patients treated with lansoprazole, cases of colitis have been reported very rarely - if severe and / or persistent diarrhea occurs, discontinuation of lansoprazole should be considered.The use of lansoprazole is not recommended in children due to limited clinical data. Treatment of young children should be avoided (less than a year), because the available data do not show a beneficial effect in the treatment of gastro-oesophageal reflux. Due to the sucrose content, the drug should not be used in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Due to the lack of clinical trials, use during pregnancy is not recommended. When deciding whether to breastfeed or treat lansoprazole, consider the benefits of breastfeeding for the baby and the benefits of lansoprazole for the mother.

Lansoprazole is well tolerated and side effects are usually mild and transient. Common: vomiting, nausea, diarrhea, abdominal pain, constipation, flatulence, dry mouth or throat, rash, urticaria and pruritus, headache and dizziness, increased liver enzymes, fatigue. Uncommon: depression, thrombocytopenia, eosinophilia, leukopenia, hip fracture, wrist or spine, edema. Rarely: pancreatitis, esophageal candidiasis, tongue inflammation, taste erosion, erythema multiforme, ecchymosis, purpura, hair loss, photosensitivity, drowsiness, tremor, paresthesia, anxiety, insomnia, hallucinations, confusion, hepatitis, jaundice, interstitial nephritis , anemia, joint pain, muscle aches, visual disturbances, angioneurotic edema, hyperhidrosis, anorexia, impotence, fever. Very rare: colitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, pancytopenia, gynecomastia, anaphylactic shock, increased cholesterol and triglycerides, hyponatremia. Not known: subcutaneous cutaneous lupus erythematosus, hypomagnesemia.

Orally.Duodenal ulcer30 mg once daily for 2-4 weeksPeptic ulcer disease: 30 mg once a day for 4-8 weeksReflux oesophagitis: 30 mg once a day for 4-8 weeksPrevention of reflux oesophagitis15-30 mg once a day. Symptomatic treatment of gastroesophageal reflux disease15-30 mg once daily for 4 weeks; If the lesions are not fully healed during the 4 weeks of 30 mg, further tests are recommended.Gastric and duodenal ulceration and alleviation of symptoms in patients requiring constant NSAID treatment: 30 mg once a day for 4-8 weeks; in patients at special risk or in cases of difficult to heal ulcers, higher doses and / or longer therapy should be used.Prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk15-30 mg once a day.Zollinger-Ellison syndrome: individually, starting with a dose of 60 mg per day, there is no prescribed maximum period of use of the drug, a daily dose of more than 120 mg should be given in two divided doses.eradicationHelicobacter pylori: 30 mg twice daily for 7-14 days in combination with antibacterial treatment according to one of the following schemes: a) Amoxicillin 1 g 2 times daily and Clarithromycin 250-500 mg twice daily; b) clarithromycin 250 mg twice daily and Metronidazole 400-500 mg twice daily; c) amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily. Eradication rateH. pylori reaches 90% when clarithromycin is used with lansoprazole in combination with amoxicillin or metronidazole. Scheme c) combined treatment is characterized by a lower eradication rate compared to the clarithromycin containing scheme, it can be used in the event of contraindication to eradication using clarithromycin in a population with little resistance to metronidazole.Special groups of patients. In elderly patients, unless there are significant clinical indications, a 30 mg daily dose should not be exceeded. In patients with moderate or severe hepatic impairment, the daily dose of lansoprazole should be reduced by 50% and the patient should be monitored regularly. No dose adjustment is required in patients with mild hepatic impairment or in patients with impaired renal function.Way of giving. The capsules should be swallowed whole with water; do not chew it, do not chew it.The product should be taken once a day, preferably in the morning, at least 30 minutes before a meal, and in eradicationH. pylori 2 times a day - in the morning and in the evening, before a meal.