Omeprazole capsules 10mg, No. 28 Teva

• peptic ulcer of the stomach and duodenum, incl. relapse prevention;

• gastroesophageal reflux disease (GERD), reflux esophagitis, incl. relapse prevention;

• erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

• erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy);

• Zollinger-Ellison syndrome and other pathological conditions associated with resolved gastric secretion

Inside, in the morning before meals, or during meals, with a little water; the contents of the capsule must not be chewed.

Adults
With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis
20 mg 1 time per day. The course of treatment is 4-8 weeks. In some cases, it is possible to increase the dose to 40 mg per day.

With maintenance therapy GERD for the prevention of relapse
10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis - for life.
In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs (including for the prevention of relapses)
10-20 mg per day.

In Zollinger-Ellison syndrome, the
dose is set individually. The recommended starting dose is 60 mg once a day. If necessary, the dose is increased to 80-120 mg per day, in which case it should be divided into two doses.

Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori
20 mg 2 times a day in combination with antibacterial drugs for 7 days. In patients with gastric ulcer and / or duodenal ulcer in the acute stage, it is possible to prolong monotherapy with omeprazole.

In elderly patients, dose adjustment is not required.

No dose adjustment is required in patients with impaired renal function.

In patients with liver failure, the maximum daily dose is 20 mg.

If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorption of the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes.

1 capsule contains:
active substance omeprazole 10.00 mg;

excipients: sugar grits [sucrose, starch syrup] 48.00 mg, sodium carboxymethyl starch type A 2.10 mg, sodium lauryl sulfate 2.99 mg, povidone 4.75 mg, potassium oleate 0.644 mg, oleic acid 0.107 mg, hypromellose 3.00 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 20.455 mg. triethyl citrate 2.345 mg, titanium dioxide (E171) 0.75 mg talc 0.095 mg.

Cellulose capsule: carrageenan 0.15 mg, potassium chloride 0.2 mg, titanium dioxide (E171) 3.1912 mg, hypromellose 39.96 mg, water 2.30 mg, sunset yellow dye (E110) 0.3588 mg, iron dye red oxide (E172) 0.5888 mg, charming red dye (E129) 0.276 mg.

• Hypersensitivity to omeprazole or any of the components of the drug;

• intolerance to fructose;

• deficiency of sucrose / isomaltose;

• glucose-galactose malabsorption;

• concomitant use with clarithromycin in patients with hepatic insufficiency, atazanavir, St. John's wort;

• pregnancy, breastfeeding period;

• age up to 18 years.

With care
Lack of liver function; failure of kidney function; simultaneous use with clarithromycin.

Trade name: Omeprazole-Teva

International Non-Proprietary Name (INN): Omeprazole

Dosage form:

enteric capsules

Composition
Dosage 10 mg
1 capsule contains:
active substance omeprazole 10.00 mg;

excipients: sugar grits [sucrose, starch syrup] 48.00 mg, sodium carboxymethyl starch type A 2.10 mg, sodium lauryl sulfate 2.99 mg, povidone 4.75 mg, potassium oleate 0.644 mg, oleic acid 0.107 mg, hypromellose 3.00 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 20.455 mg. triethyl citrate 2.345 mg, titanium dioxide (E171) 0.75 mg talc 0.095 mg.

Cellulose capsule: carrageenan 0.15 mg, potassium chloride 0.2 mg, titanium dioxide (E171) 3.1912 mg, hypromellose 39.96 mg, water 2.30 mg, sunset yellow dye (E110) 0.3588 mg, iron dye red oxide (E172) 0.5888 mg, charming red dye (E129) 0.276 mg.
Dosage 20 mg
1 capsule contains: active substance omeprazole 20.00 mg;
excipients: sugar grits [sucrose, starch syrup] 96.00 mg, sodium carboxymethyl starch type A 4.20 mg, sodium lauryl sulfate 5.98 mg, povidone 9.50 mg, potassium oleate 1.287 mg, oleic acid 0.214 mg, hypromellose 6 , 00 mg, melacrylic acid and ethyl acrylate copolymer [1: 1] 40.91 mg, triethyl citrate 4.69 mg, titanium dioxide (E171) 1.50 mg, talc 0.19 mg.
Cellulose capsule: carrageenan 0, 185 mg, potassium chloride 0.265 mg, titanium dioxide (E171) 3.60 mg, hypromellose 52.05 mg, water 3.00 mg, sunset yellow dye (E110) 0.468 mg charming red dye (E129 ) 0.096 mg, brilliant blue dye (E133) 0.336 mg.
Dose 40 mg
1 capsule contains: active substance omeprazole 40.00 mg:
excipients: sugar crumbs [sucrose, starch syrup] 1912.00 mg, sodium carboxymethyl starch type A 8.40 mg, 9 sodium lauryl sulfate 11.96 mg, povidone 19 , 00 mg, potassium oleate 2.576 mg, oleic acid 0.428 mg, hypromellose 12.00 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 81.82 mg triethyl citrate 9.38 mg, titanium dioxide (E171) 3.00 mg, talc 0.38 mg.
Cellulose capsule: carrageenan 0.283 mg, potassium chloride 0.397 mg, titanium dioxide (E171) 5.40 mg, hypromellose 78.07 mg, water 4.50 mg, sunset yellow dye (E110) 0.702 mg, charming red dye (E129) 0.144 mg, brilliant blue dye (E133) 0.504 mg.
The composition of the white ink used to write on the capsules (for all dosages): shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, propylene glycol 1-3%, butanol 4-7%, povidone 10-13 %, sodium hydroxide 0, m5 - 0.1%, titanium dioxide- (E 7) -32-36-%.

Description
Dosage 10 mg. Hard opaque cellulose capsules No. 3 with an orange body and a red cap. Printed in white ink on the lid 'O', on the body - '10'.
The dosage is 20 mg. Hard opaque cellulose capsules No. 2 with an orange body and a blue cap. Printed in white ink on the lid 'O', on the body - '20'.
The dosage is 40 mg. Hard opaque cellulose capsules No. 0 with an orange body and a blue cap. Printed in white ink on the cover 'O', on the body - '40'.
The contents of the capsules are micropellets from white to white with a yellowish or pinkish shade.

Pharmacotherapeutic group:

gastric glands secretion lowering agent - proton pump inhibitor.

ATX code: A02BC01

Pharmacological properties
Pharmacodynamics. It inhibits the activity of H + / K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of the secretion of hydrochloric acid. The effect of omeprazole on the last stage of the formation of hydrochloric acid is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.
When taken daily, omeprazole provides rapid and effective inhibition of day and night secretion of hydrochloric acid. The maximum effect is achieved within 4 days. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric acidity at a pH of more than 3 for 17 hours.
The action of omeprazole together with antibacterial drugs leads to the eradication of Helicobacter pylori, which allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucous membrane and stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract (GIT), and the need for prolonged antiulcer therapy.

Pharmacokinetics
Absorption and distribution . After taking the drug inside, omeprazole is rapidly absorbed from the small intestine, the maximum concentration in the blood plasma (Cmax) is reached after 0.5-3.5 hours.
Bioavailability is 30-40%, with liver failure - 100%. Plasma protein binding (albumin and acidic ?1-glycoprotein) is about 90%.
Metabolism and excretion . (Omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.). It is an inhibitor of the CYP2C19 isoenzyme.
The half-life (T1 / 2) is 0.5-1 h, with liver failure -3 hours. Clearance 300-600 ml / min.
It is excreted by the kidneys (70-80%) and through the intestines (20-30%) in the form of metabolites.
Pharmacokinetics in special clinical situations . In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.
In the elderly, the excretion of omeprazole decreases, bioavailability increases.

Indications for use

• peptic ulcer of the stomach and duodenum, incl. relapse prevention;

• gastroesophageal reflux disease (GERD), reflux esophagitis, incl. relapse prevention;

• erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

• erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy);

• Zollinger-Ellison syndrome and other pathological conditions associated with resolved gastric secretion

Contraindications

• Hypersensitivity to omeprazole or any of the components of the drug;

• intolerance to fructose;

• deficiency of sucrose / isomaltose;

• glucose-galactose malabsorption;

• concomitant use with clarithromycin in patients with hepatic insufficiency, atazanavir, St. John's wort;

• pregnancy, breastfeeding period;

• age up to 18 years.

With care
Lack of liver function; failure of kidney function; simultaneous use with clarithromycin.

Application during pregnancy and during breastfeeding

The use of omeprazole during pregnancy and breastfeeding is contraindicated due to insufficient data on efficacy and safety in this category of patients.

Method of administration and dosage

Inside, in the morning before meals, or during meals, with a little water; the contents of the capsule must not be chewed.

Adults
With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis
20 mg 1 time per day. The course of treatment is 4-8 weeks. In some cases, it is possible to increase the dose to 40 mg per day.

With maintenance therapy GERD for the prevention of relapse
10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis - for life.
In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs (including for the prevention of relapses)
10-20 mg per day.

In Zollinger-Ellison syndrome, the
dose is set individually. The recommended starting dose is 60 mg once a day. If necessary, the dose is increased to 80-120 mg per day, in which case it should be divided into two doses.

Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori
20 mg 2 times a day in combination with antibacterial drugs for 7 days. In patients with gastric ulcer and / or duodenal ulcer in the acute stage, it is possible to prolong monotherapy with omeprazole.

In elderly patients, dose adjustment is not required.

No dose adjustment is required in patients with impaired renal function.

In patients with liver failure, the maximum daily dose is 20 mg.

If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorption of the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes.

Side effect

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.
From the side of the blood and lymphatic system: rarely - hypochromic microcytic anemia in children; very rare - reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.
From the side of the immune system: very rarely - fullness, fever, angioedema, bronchoconstriction, allergic vasculitis, fever, anaphylactic shock.
From the nervous system:often - headache, dizziness, insomnia, drowsiness, lethargy (the listed side effects tend to worsen with prolonged therapy): rarely - paresthesia, confusion, hallucinations, especially in elderly patients or in severe cases of the disease; very rarely - anxiety, depression, especially in elderly patients or in severe disease.
From the side of the organ of vision: infrequently - visual disturbances, incl. decrease in visual fields, decrease in acuity and clarity of visual perception (usually disappear after discontinuation of therapy).
From the side of the organ of hearing and labyrinth disorders: infrequently - hearing impairment, incl. 'ringing in the ears' (usually resolves after stopping therapy).
From the gastrointestinal tract:often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with the continuation of therapy); infrequently - taste perversion (usually disappears after stopping therapy); rarely - a change in the color of the tongue to brown-black and the appearance of benign cysts of the salivary glands when used simultaneously with clarithromycin (the phenomena are reversible after discontinuation of therapy); very rarely - dryness of the oral mucosa, stomatitis, candidiasis, pancreatitis.
On the part of the liver and biliary tract: infrequently - changes in the parameters of 'hepatic' enzymes (reversible); very rarely - hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver disease.
On the part of the skin and subcutaneous tissues:infrequently - rash, pruritus, alopecia, erythema multiforme, photosensitivity, increased sweating; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, wrist bones, femoral head (see the section 'Special instructions'); rarely - myalgia, arthralgia; very rarely - muscle weakness.
From the side of the kidneys and urinary tract: rarely, interstitial nephritis.
General disorders and disorders at the injection site: infrequently - peripheral edema (usually disappear after discontinuation of therapy); rarely, hyponatremia; very rarely - hypomagnesemia (see section 'Special instructions'), gynecomastia.

Overdose

Symptoms: blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: symptomatic therapy, hemodialysis is not effective enough. No specific antidote is known.

Interaction with other medicinal products

With simultaneous use with omeprazole, the absorption of ketoconazole may decrease.
With simultaneous use with omeprazole, the bioavailability of digoxin increases by 10% due to an increase in pH.
Omeprazole may reduce the absorption of vitamin B12 with prolonged use.
Omeprazole should not be used simultaneously with St. John's wort preparations due to the pronounced clinically significant interaction.
With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.
When administered simultaneously with omeprazole, the area of ??modes of the concentration-time curve of atazanavir decreases by 75%, therefore their simultaneous use is contraindicated.
With simultaneous use with omeprazole, it is possible to slow down the elimination of warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, since omeprazole is biotransformed in the liver with the participation of the isoenzyme CYP2C19. Doses of these drugs may need to be reduced. When using omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, naproxen, piroxicam and antacids, no clinically significant interaction has been established.

special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, because taking the drug Omeprazole-Teva can mask symptoms and delay the correct diagnosis.
A decrease in gastric acidity, including with the use of proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.
In patients with severe liver failure, it is necessary to regularly monitor the parameters of 'liver' enzymes during therapy with Omeprazole-Teva.
The drug Omeprazole-Teva contains sucrose and therefore is contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrase / isomaltose deficiency, glucose-galactose malabsorption).
When treating erosive and ulcerative lesions associated with taking NSAIDs, you should carefully consider the possibility of limiting or discontinuing NSAIDs to increase the effectiveness of antiulcer therapy.
The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.
The balance of risk and benefit of long-term (more than 1 year) maintenance therapy with Omeprazole-Teva should be regularly assessed. There is evidence of an increased risk of fractures of the vertebrae, wrist bones, and femoral head mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk of developing osteoporosis should be provided with adequate intake of vitamin D and calcium.
There are reports of severe hypomagnesemia in patients receiving proton pump inhibitor therapy, including omeprazole, for more than 1 year.
A patient receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce plasma magnesium levels (diuretics), requires regular monitoring of magnesium levels.

Influence on the ability to drive vehicles and work with equipment

Given the possibility of the appearance of undesirable effects on the part of the central nervous system and the organ of vision, during the period of treatment with omeprazole, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

капсулы кишечнорастворимые 10мг, 20 мг, 40 мг.
ѕо 6 или 7 капсул в блистер из алюминиевой фольги/ѕ¬’/ѕ¬?’ и полиамидной пленки/алюминиевой фольги/ѕ¬’.
ѕо 5 блистеров по 6 капсул или пи 2 или 4 блистера по 7 капсул вместе с инструкцией по применению в картонную пачку.

—рок годности

2 года.
Ќе примен¤ть по истечении срока годности, указанного на упаковке.

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