LANSOPRAZOL is a brand name for Lansoprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lansoprazol 15 mg capsules gastro-resistant capsules are indicated for use in adults, • Treatment of duodenal and gastric ulcer • Treatment of oesophagitis by reflux • Prevention of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) by concomitant administration of antibiotic appropriate for…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment of duodenal ulcer:
The recommended dose is 30 mg once daily for 2 weeks. In patients whose healed is not complete after this period, treatment will be continued at the same dosage, for an additional two weeks.
Treatment of gastric ulcer:
The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients whose healing is not complete after this period, treatment may be continued at the same dosage, for an additional 4 weeks.
Reflux oesophagitis:
The recommended dose is 30 mg once daily for 4 weeks. In patients whose recovery is not complete after this period, the treatment may be continued at the same dose for an additional 4 weeks. Prophylaxis of reflux oesophagitis: 15 mg once daily.
The dose may be increased up to 30 mg daily as necessary.
Eradication of Helicobacter pylori:
The choice of appropriate combination therapy should be made according to official local recommendations regarding bacterial resistance, duration of treatment, (usually 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.
The recommended dose is 30 mg of Lansoprazole twice daily for 7 days in combination with one of the following: clarithromycin 250-500 mg twice daily + 1 g of amoxicillin twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily Eradication rates of H.
pylori up to 90%, are achieved when clarithromycin is combined with Lansoprazole gasto-resistant capsules and amoxicillin or metronidazole. Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.
The use of a dose comprising lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been studied. Using this combination, lower eradication rates were observed than for dosages involving clarithromycin.
They can be adapted for patients who cannot take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low. Treatment of NSAID induced duodenal ulcers and benign gastric ulcer in patients requiring continued NSAID treatment: 30 mg once daily for four weeks.
Tabulated list of adverse reactions. Frequencies are defined as common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
For all post-marketing adverse reactions, it is not possible to apply any frequency of adverse reactions, so they are reported with an "indeterminate" frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Common Uncommon Rare Very rare Frequency not known Hematological and lymphatic system disorders Thrombo- cytopenia, Eosinophilia, Leucopenia Anaemia Agranulocytosis, pancytopenia Immune system disorders Anaphylactic shock Metabolism and nutrition disorders Hyponatremia* Hypomagnesaemia*, hypocalcaemia*#, hypokalaemia*# Psychiatric Disorders Depression Insomnia, Hallucination, confusion Visual hallucinations Nervous system Disorders Headache, dizziness Impatience, dizziness, Paresthesia, drowsiness, tremor Eye disorders Visual disturbances.
4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Malignant gastric tumor As with other anti-ulcer treatments, the possibility of malignant gastric tumour should be rule out when treating a gastric ulcer with lansoprazole as lansoprazole can mask the symptoms and delay the diagnosis.
5). Hypomagnesaemia Severe hypomagnesaemia has been reported rarely in patients treated with proton pump inhibitors (PPIs) such as lansoprazole for at least three months, and in most cases for one year. Hypomagnesaemia can manifest itself by severe clinical sign such as fatigue, tetany, delirious flushing, convulsions, dizziness and ventricular arrhythmia, but it can begin insidiously and go unnoticed.
8). In most patients, hypomagnesaemia (and hypomagnesaemia associated with hypocalcaemia and/or hypokalaemia) improved after magnesium supplementation and PPI discontinuation. , diuretics), blood magnesium testing should be considered by health care professionals prior to initiation of PPI therapy and then regularly during treatment.
Influence on the absorption of vitamin B12 Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria.
This should be taken into account in patients with reduced reserves or with risk factors for decreased absorption of vitaminB12 during long-term treatment or if clinical symptoms are observed. 2). Gastrointestinal bacterial infections Lansoprazole, like other PPI treatments, may be associated with an increased risk of infection with Clostridium difficile.
A decreased in gastric acidity due to lansoprazole may increase levels of bacteria normally found in the gastrointestinal tract. Treatment with lansoprazole may lead to a slight increased risk of gastrointestinal infections especially due to Salmonella and Campylobacter.
Eradication of Helicobacter pylori In patients with peptic ulcers, the possibility of infection with H. pylori as an etiological factor should be considered. pylori, then the conditions for the use of these antibiotics should also be followed.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients whose healing is not complete, the treatment may be continued for an additional 4 weeks. In patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.
Prevention of NSAIDs induced duodenal and gastric ulcers in at risk patients (over 65 years of age, or with history of gastric or duodenal ulcer) requiring prolonged NSAIDs treatment: 15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.
Symptomatic gastro-oesophageal reflux disease:
The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is achieved quickly. Individual dose adjustment should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Syndrome de Zollinger-Ellison:
The recommended initial dose is 60 mg once daily. The dosage should be adjusted individually and the treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.
Special population Renal function:
No dose adjustment is required in patients with renal impairment. 2).
Elderly:
Due to reduced clearance of lansoprazole in the elderly subjects, individual dose adjustment may be necessary. A daily dose of 30 mg should not be exceeded in the elderly unless there are relevant clinical indications. 3). Treatment in infants less than one year of age should be avoided as the available clinical data have not demonstrated a beneficial effects of lansoprazole in the treatment of gastro-oesophageal reflux disease.
Mode of administration For optimal effect, Lansoprazole should be taken once daily in the morning, except in the case of radication H. pylori for which treatment should be twice a day, once in the morning and once in the evening. 2).
Capsules should be swallowed whole with liquid. g. yoghurt, apple sauce) to facilitated administration. 2). After preparing the suspension or mixture, the drug should be administered immediately.
Long term treatment Due to limited safety data in patients on maintenance therapy for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients. Colitis Very rarely cases of colitis have been reported in patients on lansoprazole.
Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered. g. g. corticosteroids or anticoagulants], presence of a serious co-morbidity factor or the prolonged use of NSAID in maximum recommended doses).
Risk of bone fracture Proton pump inhibitors, especially if used in high doses and for a prolong period of time (>1 year), may moderately increase the risk of hip, wrist and vertebrae fracture, mainly in the elderly or in the presence of other identified risk factors.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should managed according to current recommendation and receive an appropriate intake of vitamin D and calcium.
Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very occasional cases of SCLE. If lesions develop, especially on skin areas exposed of the sun, and if they are accompanied by arthralgia, the patient should seek medical attention promptly and the health care professional should consider stopping lansoprazole.
The occurrence of SCLE after treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Interference with laboratory tests Increased levels of Chromogranin A (CgA) may interfere with tests performed for the exploration of neuroendocrine tumours.
1). If CgA and gastrin levels have not normalized after initial measurement, measurements should be repeated 14 days after discontinuation of proton pump inhibitor therapy. Loansoprazole gastro-resistance capsule containe sucrose As Lansoprazole contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.