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Omez (Omeprazole) 10 mg, 30 capsules




The instruction for medical use of OMEZ® medicine Trade названиеОмез® the International unlicensed name Omeprazolum Medicinal Formakapsula kishechnorastvorimy, 10 mg One capsule contains Structure: active agent – omeprazolum of 10 mg, excipients: Mannitolum, krospovidon, hydroxypropyl methyl cellulose, polosamer 407, Megluminum, K-30 povidone, kishechnorastvorimy cover: methacrylic acid a kopolimer (type C) (eudragit L 100-55), triethyl citrate, magnesium stearate, structure of the capsule: body: titan E171 dioxide, ferrous oxide (III) yellow E172, blue patent V E131, gelatin, lid: D&C red, FD&С blue, FD&С red, FD&С yellow, the titan E171 dioxide, ferrous oxide (III) yellow E172, gelatin, black ink (the shellac, alcohol dehydrated, 2 propyl alcohol, butanol, propylene glycol, ferrous oxide (III) black E172, the water purified). OpisanieTverdyy gelatin capsules, size No. 3, with an opaque lid of lavender color and the opaque body of yellow color, with an inscription black ink OMEZ 10 on a lid and the body (for a dosage of 10 mg). Contents of capsules – from a pellet, spherical to an elliptic form, from white till light yellow color. Pharmacotherapeutic gruppaprotivoyazvenny drugs and drugs for treatment of a gastroegzofagealny reflux. Inhibitors of the protonew pump. Omeprazolum. The ATX A02BC01 code Pharmacological svoystvapharmakokinetikaomeprazol is put into acid resisting pellets which are dissolved only in intestines. At intake it is quickly absorbed from digestive tract. Meal does not affect bioavailability of drug. At reception of 20-40 mg of omeprazolum the bioavailability is about 40%. The peak of concentration of omeprazolum in blood plasma is reached within 0.5 – 3.5 hours. Communication with proteins of plasma – about 95%. Omeprazolum is metabolized in a liver. Metabolism is carried out through the system of P450 cytochrome (CYP2C19 isoform – S-Mephenytoinum a hydroxylase). Concentration of omeprazolum in plasma does not correlate with degree and duration of suppression of secretion of Acidum hydrochloricum (t½ – 0.5-1 hour, and the anti-secretory effect lasts up to 2-3 days). The most part of drug is removed by kidneys in the form of metabolites. Elimination half-life makes 0.5-1 hours PharmakodinamikaOmez treats benzimidazolny derivatives. In acidic environment of covering cells of a stomach omeprazolum turns into an active metabolite – sulphenamide which it is irreversible contacts one of the N+,k cysteic groups +-ATF-azy and inhibits activity of enzyme (proton pomp). Thus, omeprazolum interferes with process of a kislotoobrazovaniye at the level of a final stage of synthesis of hydrochloric acid that leads to decrease in level of basal and stimulated secretion, irrespective of the irritant nature. The inhibition of activity of enzyme has dose-dependent character. Indications – symptoms of a gastroesophageal reflux, such as heartburn, acid eructation the Route of administration and dozydlya adults. Inside, washing down with enough water (contents of the capsule cannot be chewed), in 30 min. prior to food. If the patient cannot swallow the capsule entirely, it is possible to dissolve its contents in a small amount of water or fruit juice (not to dissolve in carbonated drinks). The received solution of drug should be drunk right after preparation, washing down in addition ½ glass of water. Symptoms of a gastroesophageal reflux, such as heartburn, an acid otryzhkaobychny dose of the drug Omez makes 10 mg (1 capsule) once a day. The maximum daily dose of drug should not exceed 20 mg. Always the smallest effective dose has to be used. The maximum course of treatment without consultation of the doctor – 14 days. The interval between 14-day courses of treatment has to make not less than 4 months. If within 2 weeks the relief of symptoms is not observed or they are aggravated, it is necessary to see the attending physician. Use of drug in special cases the Opportunity use of the drug Omez in special cases is estimated by the doctor. The renal failure Dose adjustment is not required. The abnormal liver function At patients with an abnormal liver function bioavailability and clearance of Omeprazolum increases. Before use it is necessary to consult with the doctor. Advanced age In spite of the fact that the speed of metabolism of Omeprazal at elderly people decreases, dose adjustment at use of drug in a daily dose of 20 mg and less is not required. Side effects – thorax pains, tachycardia or bradycardia, heartbeat, hypertensia, peripheral hypostases – lack of appetite, a food faddism, an atrophy mucous language, dry language, esophageal candidiasis, a meteorism, irritation of intestines – moderate tranzitorny increase in activity of transaminases, pancreatitis – a hyponatremia, a hypoglycemia, increase in body weight – spasms, muscle weakness, joint pains, the lower extremity pains – a depression, aggression, hallucinations, drowsiness or insomnia, confusion of consciousness, nervousness, a tremor, apathy, feeling of alarm, dizziness, paresthesias – disorders of vision, sonitus, nasal bleeding, a sore throat hemorrhagic rash and/or petechias, inflammation, an itching, dryness of integuments, a hyperhidrosis, an alopecia – urticaria, an itching, a Quincke’s disease – interstitial nephrite, infections of urinary tract, a proteinuria, a hamaturia, a glucosuria – pain in testicles, ginekomastiyaredko – a neutropenia, a leukopenia, an agranulocytosis, a leukocytosis, thrombocytopenia, anemia, including hemolytic anemia, a pancytopenia – hepatocellular, cholestatic or mixed gepatitochen is rare – a Lyell’s disease, Stephens-Johnson’s syndrome, a multiformny erythema – risk of developing spinal fractures, necks of a hip, the zapyastyachastot is unknown – the Contraindication hypomagnesiemia – hypersensitivity to any of drug components – pregnancy and the period of a lactation – children’s and teenage age up to 18 years Medicinal vzaimodeystviyavozmozhnost of interaction Omez with other medicines are limited. Omez is metabolized in a liver through a system P450 cytochrome therefore at simultaneous use with drugs which are metabolized in a liver also with the participation of this system Omez can reduce their removal. Omez slows down excretion of diazepam, Phenytoinum and anticoagulants, such as warfarin. At combined use with anticoagulants the control of blood test, a prothrombin vremeniye, correction of a dose of Omez.Omez is necessary, lowering acidity of gastric juice, can reduce absorption of an itrakonazol, ketokonazol, pozakonazol, erlotinib. The concomitant use of omeprazolum with pozakonazoly and erlotiniby is not recommended. DigoksinSovmestnyy treatment by omeprazolum (20 mg a day) and digoxin at healthy subjects increased bioavailability of digoxin by 10%. About toxicity of digoxin it is reported seldom. However it is necessary to show care when assigning high doses of omeprazolum at patients of advanced age. It is necessary to strengthen therapeutic medicinal monitoringpr combined use of a methotrexate with inhibitors of a proton pomp at some patients the slight increase of concentration of a methotrexate in blood plasma was observed. At treatment by high doses of a methotrexate it is necessary to stop intake of omeprazolum temporarily. At joint intake of omeprazolum with klaritromitsiny or erythromycin concentration of omeprazolum in blood plasma increases. Joint intake of omeprazolum with amoxicillin or metronidazole does not affect concentration of omeprazolum in blood plasma. Influence of omeprazolum on antiacid means, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol is not revealed. Special ukazaniyapered the beginning and after the end of treatment the endoscopic control for an exception of a malignant new growth as treatment by Omez can disguise symptomatology is obligatory and delay the correct diagnostics. At long-term treatment by Omez there can be atrophic gastritises. Use in a pediatriieffektivnost and safety of use Omez at children up to 18 years it is not studied.Use for patients from the liver broken by function Omez is metabolized in a liver and at patients from the liver broken by function the elimination half-life of drug is extended therefore the drug dosage at such patients has to be reduced. The feature of influence on ability to run the vehicle or potentially dangerous mekhanizmamiuchityvy side effects of drug should be careful at control of transport or other types of activity demanding the increased speed of psychomotor reactions and concentration of attention. Overdose Symptoms: confusion of consciousness, drowsiness, a headache, disorders of vision, tachycardia, dryness in a mouth, nausea, the increased sweating. Treatment: gastric lavage, intake of activated carbon, symptomatic therapy. A form of release and upakovkapo 10 capsules place in strip packaging from aluminum foil. On 3 strip packagings from aluminum foil together with the instruction for use in the state and Russian languages put in a pack from cardboard. Conditions to hraneniyakhranit in the dry place protected from light at a temperature not above +25 °C. To store out of children’s reach! hraneniya3 to the godena to apply term after an expiration date. Prescription status from aptekbez the prescription of ProizvoditelD-r Reddi’s Laboratoris Limited, India the Owner registration udostovereniyad-r Reddi’s Laboratoris Limited, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality a produktsiipredstavitelstvo of the Dr. of Reddi’s Laboratoris Limited company in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45, post office box 7, ph. 8 (727) 3941688, fax: 8 (727) 3941294
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