Loseprazol® 10, 20, 40 mg
enteric-coated hard capsules
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- 1 enteric-coated hard capsule contains 10, 20, 40 mg of omeprazolum.
- Indication group:
- antiulceric agent, inhibitor of the proton pump
The following information is for health professionals only.
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Characteristics:
Omeprazolum blocks the proton pump of the parietal cells of gastric mucosa. It inhibits both basal and stimulated secretion of gastric acid regardless of the exciting stimulus.
Indications:
Without physician's recommendation: adults and juveniles older than 15 years – for short-time (14 days) symptomatic treatment of pyrosis and acidic gastroesophageal reflux.
With physician's recommendation: prevention and treatment of gastroduodenal ulcers, prevention and treatment of gastric and duodenal ulcers and erosion in connection with administration of non-steroid antirheumatics (NSAIDs), eradication of Helicobacter pylori in combination with antibiotics, treatment of reflux esophagititis, treatment of heavy reflux esophagititis in children from 1 year, treatment of symptomatic reflux disease of esophagus, treatment of Zollinger-Ellison syndrome, treatment of functional dyspepsia induced by disorder of regulation of acidic gastric secretion, prophylaxis of aspiration of acidic stomach content during total anaesthesia.
Contraindications:
Hypersensitivity to any component of the preparation. The administration of the preparation in pregnancy and lactation can be permitted only when an assumed therapeutic benefit for the mother exceeds a potential risk for the foetus.
Undesirable effects:
Loseprazol® is usually well tolerated. In the course of treatment, indigestion, such as constipation, diarrhoea, nausea, and allergic skin reactions, sporadically headaches and rarely vertigo may occur.
Interactions:
Omeprazol treatment can decelerate elimination of drugs biotransformed by identical cytochrome P 450, e.g., diazepam, warfarin, and phenytoin. Absorption of some drugs (e.g., ketokonazol or itrakonazol) can be affected by decreased acidity of gastric juice. Omeprazol can increase biological availability of digoxin by 10%.
Caution:
Patients taking Loseprazol® 10 mg without physician's recommendation should interrupt treatment and seek a physician in case that pyrosis has not improved within 5 days from beginning of treatment with the preparation Loseprazol® 10 mg or it has even deteriorated.
Prior to commencement of the treatment of gastric ulcer with the preparation Loseprazol® 20, 40 mg, malignity must be excluded as the treatment can cover or postpone manifestation of symptoms.
Dosage:
Without physician's recommendation: 2 capsules of the preparation Loseprazol® 10 mg in one daily dose, preferably in the morning, fasting. The treatment without medical supervision takes 14 consecutive days. It can be repeated once in 4 months at most.
With physician's recommendation: dosage and length of treatment should be based on the type and severity of the disease. The usual dose is 20-40 mg of Loseprazol® once a day. Eradication of H. pylori is carried out in combination with antibiotics according to usual dosage schemes. To childern over 1 year (weighing 10 kg – 20 kg) with severe reflux oesophagitis, 10 mg of omeprazol once a day is recommended. Capsules are taken before meals, preferably in the morning. In patients with hepatic insufficiency a daily dose should not exceed 20 mg.
Package:
14 or 28 capsules, 10 mg each;
14 or 28 capsules, 20 mg each;
14 or 28 capsules, 40 mg each.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: Loseprazol® 10 mg September 13, 2006; Loseprazol® 20, 40 mg December 12, 2007.
Loseprazol® 10 mg is available over the counter.
Loseprazol® 20, 40 mg is available on medical prescription only.