Symptoms of regressing gastric contents into the esophagus. Symptomatic treatment of esophageal burning problems (heartburn).
Composition:
1 capsule contains 10 mg of Omeprazole (and 48 mg of sucrose).
Action:
Omeprazole, which is a racemic mixture of two enantiomers, is a specific inhibitor of the proton pump (H+/ K+ ATPase) in the parietal cells of the gastric mucosa. It reduces the secretion of hydrochloric acid in the stomach, both basal and stimulated. Omeprazole is not stable in an acidic environment and is therefore administered orally in the form of capsules filled with coated pellets. Absorption of omeprazole is rapid and Cmax occurs about 1-2 hours after administration. The bioavailability of omeprazole after a single oral administration is approximately 40%. Multiple administration once a day increases the bioavailability to about 60%. Omeprazole binds approximately 95% of plasma proteins. It is completely metabolised by the cytochrome P450 system, mainly CYP2C19 (to hydroxyomeprazole) and partly by CYP3A4 (to the omeprazole sulfone). Almost 80% of an orally administered dose is excreted as metabolites in the urine; the remaining part with faeces. T0,5 is <1 h. In patients with hepatic impairment the metabolic rate is reduced.
Contraindications:
Hypersensitivity to the active substance or any of the excipients. Do not use with atazanavir.
Precautions:
Patients should be advised to report the following cases: taking medicines for indigestion or continuous heartburn for at least 4 weeks to check for any symptoms; onset of new symptoms or change in the nature of previously observed symptoms in patients> 45 years; weight loss, anemia, gastrointestinal bleeding, dysphagia, swallowing pain, persistent or bloody vomiting, stomach ulcer or surgery, jaundice or other conditions (eg liver and kidney failure). Patients with long-term recurrent symptoms of indigestion or heartburn should undergo regular medical check-ups. Patients treated with omeprazole for at least 3 months (in most cases for one year) have experienced severe hypomagnesaemia; 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 omeprazole treatment and then periodically during treatment. Treatment with omeprazole may cause a slight increase in the risk of gastrointestinal infections with such bacteria asSalmonella spp. And Campylobacter spp. Patients should not take other gastric acid suppressants (eg H-receptor antagonists) during treatment with omeprazole2), without medical consultation.Due to the sucrose content, the drug should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
During pregnancy and breastfeeding, use only in cases where the benefit for the mother outweighs the potential risk to the fetus or infant breastfeeding. Omeprazole (doses up to 80 mg / day) given to women during labor did not cause any adverse effects on the fetus. Animal studies have not confirmed the adverse effects of omeprazole used during pregnancy and lactation; no evidence of embryotoxicity or teratogenicity was found.
Side effects:
Common: headache, diarrhea, constipation, bloating (including gas), epigastric pain, nausea, vomiting. Uncommon: dizziness, paresthesia, photosensitivity, malaise, drowsiness, insomnia, increased liver enzymes, rash, dermatitis and / or pruritus, urticaria, malaise.Rare: recurrent confusion, agitation, aggression, depression and hallucinations (mainly in severely ill patients), gynecomastia, dryness or oral mucositis, gastrointestinal candidiasis, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, encephalopathy in patients with pre-existing severe hepatic disease, hepatitis with or without coexisting jaundice, hepatic failure, joint pain, muscle pain, muscle weakness, impotence, rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, hypersensitivity reactions , angioneurotic edema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, hyperhidrosis, peripheral edema, blurred vision, dysgeusia, hyponatremia. Frequency unknown: hypomagnesemia.
Dosage:
Orally. Adults: The starting dose is 20 mg (2 capsules once a day). If the symptoms improve, the dose should be reduced to 10 mg (1 capsule) once a day. If symptoms of heartburn recur, the dose can be increased to 20 mg once a day. Treatment time - 14 days.Special groups of patients. In patients with liver failure, the daily dose should be reduced. There is no need to change the dosage in patients with renal insufficiency or in the elderly.Way of giving. The drug should be taken in the morning, before a meal, washed down with water. Swallow the capsule whole; it should not be chewed or crushed before swallowing. If you have difficulty swallowing, the capsule can be opened and its contents poured into fruit juice or other acidic liquid, mix and drink.
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