Name:
Omez capsules 10mg in blister packs №10×3
Description:
Hard gelatin capsules, size №3, opaque, with a light purple cap and a yellow body, with the inscription “OMEZ 10” in black on both parts of the capsule. The main active ingredient Omeprazole Release form 10 capsules in an aluminum/aluminum blister pack or in an aluminum/aluminum strip. 3 blister packs or 3 strips, together with instructions for medical use, are placed in a cardboard pack. Dosage 10 mg in blisters in a package No. 10×3 Special instructions Taking the drug at the same time with food does not affect its effectiveness. Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis. Application features: Pediatric use: The safety and efficacy of omeprazole in children has not been established. Use in Elderly Patients: There is no need to adjust the dose according to age. However, the possibility of a slight decrease in the rate of excretion and an increase in the bioavailability of the drug in elderly patients was noted. Use in patients with impaired liver function: In patients with this pathology, it may be necessary to reduce the dose, since omeprazole is extensively metabolized by the liver and the excretion rate in such patients is reduced compared to patients with preserved liver function. In patients with severe hepatic impairment, the daily dose of omeprazole should be 10-20 mg. Use in patients with renal insufficiency: Metabolites of omeprazole are excreted primarily in the urine. Patients with renal insufficiency require dose adjustment. Use in Pregnancy and Lactation: The safety and efficacy of omeprazole in pregnant and lactating women has not been studied. Therefore, omeprazole is not indicated for pregnant and lactating women. Influence on the ability to drive a car and control mechanisms: the drug in most cases does not affect the ability to drive a car and control moving mechanisms. However, in rare cases, adverse reactions such as dizziness, visual disturbances may occur. In the event of such violations, the patient should refrain from activities that require increased accuracy and concentration. Indications for use Treatment: gastroesophageal reflux disease; heartburn; belching sour; discomfort and burning in the epigastric region, including those associated with taking NSAIDs. Dosage and administration Take orally with a small amount of water (do not chew). It is recommended to take the drug at a dose of 10-20 mg 1 time / day until the symptoms disappear. If there is no improvement after 4 weeks of therapy, an additional examination is recommended. Use during pregnancy and lactation is contraindicated in pregnancy and lactation. Interaction with other drugs Omeprazole, by acting on the acid-peptic factor, can affect the bioavailability of drugs, the absorption of which depends on pH, and omeprazole can also prevent the destruction of drugs that are sensitive to acid. Therefore, the simultaneous use of itraconazole or ketoconazole and omeprazole may lead to a decrease in the rate of absorption of other drugs. Omeprazole has a moderate inhibitory effect on CYP2C19 (the main enzyme responsible for the metabolism of omeprazole). Thus, the metabolism of drugs that are also metabolized by CYP2C19 may be slowed down, which may lead to an increase in their clinical effect (warfarin and other vitamin K antagonists, cilostazol, diazepam, phenytoin). Since omeprazole is metabolized by CYP2C19 and CYP3A4, administration of strong inhibitors of these enzymes (eg, clarithromycin and voriconazole) may lead to an increase in serum concentrations of omeprazole. The simultaneous appointment of omeprazole and voriconazole can lead to a two-fold increase in the concentration of omeprazole in the blood serum. With prolonged treatment, as well as in patients with severe hepatic insufficiency, dose adjustment may be required. Drugs that induce CYP2C19 and CYP3A4 (for example, rifampicin, St. John’s wort), when used together with omeprazole, can lead to a decrease in serum concentrations of omeprazole. An interaction of omeprazole with atazanovir and tacrolimus has been described, the mechanism of which is not completely clear. The combined use of omeprazole (40 mg 1 time / day) and atazanavir 300 mg / ritonavir 100 mg in healthy volunteers led to a significant decrease in the content of atanovir. Omeprazole, like other PPIs, should not be co-administered with atazanavir. Co-administration of omeprazole and tacrolimus may increase plasma concentrations of the latter. The combined use of omeprazole and digoxin can lead to an increase in the bioavailability of digoxin by 10%. Cases of digitalis intoxication have been described. Caution should be exercised when co-prescribing drugs, especially in elderly patients. Co-administration of omeprazole and clopidogrel leads to a decrease in the therapeutic effect of clopidogrel. ContraindicationsIncreased sensitivity to the drug; pregnancy; lactation period; childhood. Omeprazole, like other proton pump inhibitors, should not be co-administered with nelfinavir. Composition of meprazole – 10 mg Excipients: mannitol, crospovidone, poloxamer (407), hydroxypropyl methylcellulose (1828), meglumine, povidone (K-30), methacrylic acid copolymer (type C), triethyl citrate, magnesium stearate. Cassula shell composition: iron oxide yellow (E172), FD&C blue #1 (E133), FD&C yellow #6 (E110), FD&C red #40 (E129), FD&C red #28, titanium dioxide (E171), gelatin, sodium lauryl sulfate. Ink composition: shellac, black iron oxide (E172), indigo carmine (E132), alluring red (E129), brilliant blue (E133), quinoline yellow (E104), aluminum hydroxide (III). Overdose Overdose symptoms are blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia. There is no specific antidote. Treatment is symptomatic. Due to the fact that a significant part of the drug in plasma is in protein-bound form, hemodialysis is not effective enough. Side effects The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting. In rare cases, the following, usually reversible, side effects may occur. On the part of the digestive system: dry mouth, taste disturbance, stomatitis, transient increase in the level of “liver” enzymes in plasma; in patients with previous severe liver disease – hepatitis (including with jaundice), impaired liver function. From the nervous system: dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, with a previous severe liver disease – encephalopathy. From the musculoskeletal system: muscle weakness, myalgia, arthralgia. From the hemopoietic system: leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia. On the part of the skin: itching; rarely, in some cases – photosensitivity, erythema multiforme, alopecia. Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock Other: visual disturbances, peripheral edema, increased sweating, fever, gynecomastia; rarely – the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible). There have also been reports of the following adverse events observed during the use of omeprazole. Since information about them was obtained from non-medical sources, it is not always possible to estimate their frequency and causal relationship with the drug. Digestive organs: pancreatitis (sometimes fatal, liver necrosis (sometimes fatal), hepatic encephalopathy. Cardiovascular system: chest pain, angina pectoris, tachycardia, palpitations, increased blood pressure. Storage conditions Store the drug at temperature up to 25°C in a dry, dark place.Keep out of the reach of children Buy Omez capsules 10mg №10×3
INN | omeprazole |
---|---|
The code | 49 248 |
Barcode | 8 901 148 225 893 |
Dosage | 10mg |
Active substance | Omeprazole |
Manufacturer | Dr. Reddy's Laboratories Ltd, India |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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