The instruction for medical use
of OMEZ medicine
the Trade name
Mezhdunarodnoye the unlicensed
name Omeprazolum Dosage Form
of the Capsule kishechnorastvorimy, 10 mg, 40 mg
One capsule contains Structure:
active agent – omeprazolum of 10 mg or 40 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 #28, FD&С blue #1, FD&С red #40, FD&С yellow #6, titan E171 dioxide, ferrous oxide (III) yellow E172, gelatin, black ink.
Solid 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).
Solid gelatin capsules, size No. 0, with an opaque lid of yellow color and the opaque body of blue color, with an inscription black ink OMEZ 40 on a lid and the body (for a dosage of 40 mg).
Contents of capsules – spherical pellets from white till light yellow color.
Antiulcerous drugs and drugs for treatment of a gastroegzofagealny reflux. Inhibitors of the protonew pump.
The ATC A02BC01 code
Pharmacokinetics Omeprazolum properties is put into acid resisting pellets which are dissolved only in intestines. At intake it is quickly absorbed from digestive tract. 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). Elimination half-life makes 0.5-1 hour. 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).
At reception of 20-40 mg of omeprazolum the bioavailability is about 40%. Meal does not affect bioavailability of drug. The most part of drug is removed by kidneys in the form of metabolites.
Omez belongs to 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.
– a peptic ulcer of a stomach and duodenum
– a reflux esophagitis, an esophagitis, including not erosive and erosive esophagitis, a gastroesophageal reflux disease
– Zollingera-Ellison’s syndrome
– stomach disease Helicobacter pylori-associated as a part of complex therapy
– the digestive tract erosive cankers connected with intake of non-steroidal anti-inflammatory drugs
the Route of administration and doses
For adults and children are more senior than 16 years.
Drug is recommended to be used before food, without damaging the capsule, to wash down with a small amount of liquid.
The recommended Omez’s dose for treatment of a peptic ulcer of a duodenum – 20 mg once a day within 4 weeks. Treatment can be prolonged for 4 weeks.
The recommended Omez’s dose for treatment of a peptic ulcer of a stomach – 40 mg once a day within 4-8 weeks.
The recommended Omez’s dose for a short course of treatment of a gastroesophageal reflux disease (GERD), not erosive esophagitis – 20 mg daily once a day within 4 weeks.
For patients with an erosive esophagitis and with the complicated Omez GERD forms it is appointed in a dose of 20 mg within 4 – 8 weeks.
In case of insufficient effectiveness of the above-stated therapy at patients with the I-IV stages of GERD it is recommended to accept 40 mg within 4 – 8 weeks once a day. At more long-term treatment the dose of 20 mg at reception is appointed once a day, in the morning.
The recommended initial dose of Omez for the patients suffering from Zollingera-Ellison’s syndrome – 60 mg. If necessary the dose is increased to 120 mg a day, dividing into 2 receptions.
Stomach disease Helicobacter pylori-associated as a part of complex therapy: the recommended dose of 20 mg 2 times a day (it is strict in 12 hours, in the morning and in the evening) in a combination with antimicrobic therapy within 7 – 14 days.
The digestive tract erosive cankers connected with intake of non-steroidal anti-inflammatory drugs
the Recommended dose – 20 mg once a day within 4-8 weeks. For the purpose of prevention of appearance of new ulcers at use of non-steroidal anti-inflammatory drugs the long-term use of drug on 20 mg once a day, is recommended in the morning.
– 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, a gynecomastia
– a neutropenia, a leukopenia, an agranulocytosis, a leukocytosis, thrombocytopenia, anemia, including hemolytic anemia, a pancytopenia
– the hepatocellular, cholestatic or mixed hepatitis
– a Lyell’s disease, Stephens-Johnson’s syndrome, a multiformny erythema
of the Contraindication
– hypersensitivity to any of drug components
– pregnancy and the period of a lactation
– children’s and teenage age up to 16 years
of the Possibility 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 is necessary.
Omez, lowering acidity of gastric juice, can reduce absorption of an itrakonazol, ketokonazol.
Before 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 pediatrics
the Efficiency and safety of use Omez at children up to 16 years 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.
Features of influence on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug it is necessary to be careful at control of transport or other types of activity demanding the increased speed of psychomotor reactions and concentration of attention.
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.
Form of release and packing
Omez of 10 mg:
Capsules No. 10 are placed in strips from aluminum foil. On 3 strips together with the instruction for use in the state and Russian languages put in a pack from cardboard.
Omez of 40 mg:
Capsules No. 7 are placed in strips from aluminum foil. On 4 strips together with the instruction for use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place protected from light at a temperature not above +25 °C.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
Dr. of Reddi’s Laboratoris Limited Producer 7-1-25 of Amiirpet,
Hayderebad – 500016, A.P., India
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office Dr. of Reddi’s Laboratoris Limited in the Republic of Kazakhstan:
050057 Almaty, Dzhandosov St., 21
a post office box 7,
ph. 8 (727) 3941688
fax: 8 (727) 3941294