Omeprazole capsules 0.02 g blister No. 30

Instructions Omeprazole capsules 0.02 g blister No. 30

Composition

active ingredient: omeprazole;

1 capsule contains omeprazole pellets equivalent to omeprazole – 10 mg or 20 mg or 40 mg;

excipients in the composition of the pellets: sugar spheres (sucrose, corn starch), sodium lauryl sulfate, sodium hydrogen phosphate anhydrous, mannitol, hypromellose, macrogol 6000, talc, polysorbate-80, methacrylate copolymer dispersion, titanium dioxide (E 171);

composition of the capsule shell:

10 mg – gelatin, red iron oxide (E 172), titanium dioxide (E 171);

20 mg – gelatin, azorubine (carmoisine) (E 122), black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171);

40 mg – gelatin, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172).

Dosage form

Capsules.

Main physicochemical properties:

10 mg. Hard gelatin capsules. The capsule body and cap are light pink. The capsule contents are white to almost white-cream colored pellets, spherical in shape without visual defects;

20 mg. Hard gelatin capsules. White body and pink capsule cap. Capsule contents – white to almost white-cream colored pellets, spherical in shape without visual defects;

40 mg. Hard gelatin capsules. White body and beige capsule cap. Capsule contents – white to off-white, spherical pellets without visual defects.

Pharmacotherapeutic group

Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors. ATC code A02B C01.

Pharmacological properties

Pharmacodynamics.

Mechanism of action

Omeprazole is a racemic mixture of two enantiomers that reduces gastric acid secretion through a targeted mechanism of action. It is a specific proton pump inhibitor (PPI) in the parietal cells of the stomach. It acts rapidly and causes controlled reversible inhibition of gastric acid secretion when administered once daily.

Omeprazole is a weak base that is concentrated and converted to the active form in the acidic environment of the intracellular tubules in parietal cells, where it inhibits the enzyme H+/K+-ATPase - the acid pump. This effect on the final stage of the process of gastric acid formation is dose-dependent and provides highly effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulus.

Pharmacodynamic effects

All observed pharmacodynamic effects can be explained by the effect of omeprazole on acid secretion.

Effect on gastric acid secretion

Oral administration of omeprazole once daily causes rapid and effective inhibition of daytime and nighttime gastric acid secretion, with the maximum effect being achieved within 4 days of treatment. In patients with duodenal ulcer, a mean reduction in gastric acidity (approximately 80%) occurs within 24 hours after taking 20 mg of omeprazole, and a mean reduction in peak acid output after pentagastrin stimulation is approximately 70% 24 hours after taking omeprazole.

Oral administration of 20 mg omeprazole maintains intragastric pH ≥ 3 in patients with duodenal ulcer for an average of 17 hours out of a 24-hour period.

Due to reduced acid secretion and intragastric acidity, omeprazole dose-dependently reduces/normalizes the effect of acid on the esophagus in patients with gastroesophageal reflux disease.

The inhibition of acid secretion correlates with the area under the plasma concentration-time curve (AUC) of omeprazole, not with the actual plasma concentration at that time.

No tachyphylaxis was observed during treatment with omeprazole.

Effect on Helicobacter pylori (H. pylori)

Peptic ulcer disease, including duodenal ulcer and gastric ulcer, is associated with H. pylori. H. pylori is considered a major factor in the development of gastritis and, together with gastric acid, is a crucial factor in the development of peptic ulcer disease. H. pylori is also a major factor in the development of atrophic gastritis, which is associated with an increased risk of gastric cancer.

Eradication of H. pylori with omeprazole and antibiotics is associated with high cure rates and long-term remission of peptic ulcers.

Various dual therapy regimens have been reviewed and found to be less effective than triple therapy, but may be appropriate in cases where known hypersensitivity precludes the use of any triple combination.

Other effects related to acid suppression

A slightly increased incidence of gastric glandular cysts has been reported during long-term treatment. These changes are a physiological consequence of acid suppression, and the cysts are benign and reversible.

During treatment with antisecretory drugs, plasma gastrin concentration increases as a result of reduced hydrochloric acid secretion. As a result of reduced hydrochloric acid secretion, chromogranin A (CgA) levels increase. Increased CgA levels may interfere with the results of neuroendocrine tumor screening tests. Based on available published data, it is suggested that PPIs should be discontinued 5 to 14 days before scheduled CgA measurements. This allows CgA levels, which may be falsely elevated after PPI administration, to normalize to reference values.

During long-term treatment with omeprazole, an increase in the number of enterochromaffin-like cells (ECL) has been observed in some patients (including both children and adults), possibly due to increased serum gastrin levels. These findings are not considered to be of clinical significance.

Children

In an uncontrolled study in children (aged 1 to 16 years) with severe reflux esophagitis, omeprazole at doses of 0.7 to 1.4 mg/kg improved the course of esophagitis in 90% of cases and significantly reduced reflux symptoms. In the study, children aged 0 to 24 months with a clinical diagnosis of gastroesophageal reflux disease were treated with omeprazole at doses of 0.5, 1.0 or 1.5 mg/kg body weight. The frequency of vomiting/regurgitation episodes, regardless of dose, was reduced by 50% after 8 weeks of treatment.

Eradication of H. pylori in children

Studies have shown that omeprazole in combination with two antibiotics (amoxicillin and clarithromycin) was safe and effective in treating H. pylori infection in children aged 4 years and older with gastritis. The H. pylori eradication rate was 74.2% with omeprazole + amoxicillin + clarithromycin compared with 9.4% with amoxicillin + clarithromycin. However, there was no evidence of any clinical benefit on dyspeptic symptoms. There is no information available for children aged less than 4 years.

Pharmacokinetics.

Absorption

Omeprazole and omeprazole magnesium are acid-labile and should be administered orally as enteric-coated granules in capsules or tablets. Absorption of omeprazole is rapid, with peak plasma levels occurring approximately 1–2 hours after dosing. Absorption of omeprazole occurs in the small intestine and is usually complete within 3–6 hours. Concomitant food intake does not affect bioavailability. The systemic availability (bioavailability) of a single dose of omeprazole is approximately 40%. After repeated once-daily dosing, bioavailability increases to approximately 60%.

Distribution

The apparent volume of distribution in healthy volunteers is approximately 0.3 l/kg body weight. Omeprazole is 97% bound to plasma proteins.

Biotransformation

Omeprazole is completely metabolised by the cytochrome P450 (CYP) system. The major part of its metabolism depends on the polymorphically expressed CYP2C19, responsible for the formation of hydroxyomeprazole, the main metabolite in plasma. The other part depends on another specific isoform, CYP3A4, responsible for the formation of omeprazole sulfone. As a result of the high affinity of omeprazole for CYP2C19, competitive inhibition and metabolic interactions between drugs that are substrates for CYP2C19 are possible. However, due to the low affinity for CYP3A4, omeprazole is not able to inhibit the metabolism of other CYP3A4 substrates. In addition, omeprazole does not have an inhibitory effect on the main CYP enzymes.

Approximately 3% of Caucasians and 15-20% of Asians lack a functional CYP2C19 enzyme and are therefore referred to as “poor metabolizers”. In these individuals, the metabolism of omeprazole is likely to be catalyzed primarily by CYP3A4. After repeated administration of a 20 mg dose of omeprazole once daily, the AUC in “poor metabolizers” was 5-10 times higher than in subjects with a functional CYP2C19 enzyme (“extensive metabolizers”). The mean peak plasma concentrations were also 3-5 times higher. These findings do not affect the dosage of omeprazole.

Breeding

The plasma elimination half-life of omeprazole is generally less than 1 hour after both single and repeated once-daily dosing. Omeprazole is completely eliminated from plasma in the dose interval without any tendency for accumulation with once-daily dosing. Almost 80% of an oral dose of omeprazole is excreted as metabolites in the urine, the remainder in the feces via biliary secretion.

Linearity/nonlinearity

The AUC of omeprazole increases with repeated administration. This increase is dose-dependent and results in a non-linear relationship between AUC and dose after repeated administration. This time- and dose-dependence is due to reduced first-pass metabolism and systemic clearance, presumably due to inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulfone).

No effect of omeprazole metabolites on gastric acid secretion was found.

Special patient groups

Liver dysfunction

The metabolism of omeprazole is impaired in patients with hepatic impairment, leading to an increase in AUC. Omeprazole did not show a tendency for accumulation when administered once daily.

Kidney dysfunction

The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are not altered in patients with renal impairment.

The metabolic rate of omeprazole is slightly reduced in elderly patients (75–79 years).

Children

When treating children aged 1 year and older with the recommended doses, plasma concentrations were similar to those observed in adult patients. In children aged less than 6 months, the clearance of omeprazole is reduced due to a lower capacity to metabolize omeprazole.

Indication

Adults

– Treatment of duodenal ulcers;

– prevention of recurrence of duodenal ulcers;

– treatment of stomach ulcers;

– prevention of recurrence of stomach ulcers;

– in combination with appropriate antibiotics for the eradication of Helicobacter pylori (H. pylori) in peptic ulcer disease;

– treatment of NSAID-associated gastric and duodenal ulcers;

– prevention of NSAID-associated gastric and duodenal ulcers in patients at risk;

– treatment of reflux esophagitis;

– long-term treatment of patients with cured reflux esophagitis to prevent relapse;

– treatment of symptomatic gastroesophageal reflux disease;

– treatment of Zollinger-Ellison syndrome.

Children

Children aged 1 year and over and weighing ≥ 10 kg

- Treatment of reflux esophagitis;

- symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease.

Children aged 4 years and over and adolescents

– In combination with antibiotics for the treatment of duodenal ulcers caused by H. pylori.

Contraindication

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients of the medicinal product.

Omeprazole, like other PPIs, should not be used concomitantly with nelfinavir (see section “Interaction with other medicinal products and other types of interactions”).

Interaction with other drugs and other types of interactions.

Effect of omeprazole on the pharmacokinetics of other drugs

Drugs whose absorption depends on gastric pH

Suppression of gastric secretion during treatment with omeprazole may reduce or increase the absorption of drugs whose absorption depends on gastric pH.

Nelfinavir, atazanavir

Plasma levels of nelfinavir and atazanavir are decreased when co-administered with omeprazole.

Concomitant use of omeprazole and nelfinavir is contraindicated, as omeprazole (40 mg once daily) decreased the mean AUC of nelfinavir by approximately 40% and the mean AUC of the pharmacologically active metabolite M8 by 75–90%. The interaction may also be due to inhibition of CYP2C19 activity.

Concomitant use of omeprazole with atazanavir is not recommended. Co-administration of omeprazole (40 mg once daily) and atazanavir 300 mg or ritonavir 100 mg in healthy volunteers resulted in a 75% decrease in atazanavir AUC. Increasing the atazanavir dose to 400 mg did not compensate for the effect of omeprazole on atazanavir AUC. Concomitant use of omeprazole (20 mg once daily) with atazanavir 400 mg or ritonavir 100 mg in healthy volunteers resulted in an approximately 30% decrease in atazanavir AUC compared to atazanavir 300 mg or ritonavir 100 mg once daily.

Digoxin

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy volunteers increased the bioavailability of digoxin by 10%. Rare cases of digoxin-induced toxicity have been reported. However, caution should be exercised when prescribing high doses of omeprazole to elderly patients. Therapeutic monitoring of digoxin should be intensified.

Clopidogrel

In healthy volunteers, a pharmacokinetic (PK)/pharmacodynamic (PD) interaction was observed between clopidogrel (loading dose 300 mg/daily maintenance dose 75 mg) and omeprazole (80 mg/day orally), resulting in an average 46% decrease in the AUC of the active metabolite of clopidogrel and an average 16% decrease in the maximum inhibitory effect on (ADP-induced) platelet aggregation.

Conflicting data on the clinical manifestations of this PK/PD interaction in terms of major cardiovascular diseases have been obtained from observational and clinical studies. As a precautionary measure, the concomitant use of omeprazole and clopidogrel should be avoided.

Other medicines

The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and therefore clinical efficacy may be reduced. Concomitant use with posaconazole and erlotinib should be avoided.

Medicinal products metabolized by CYP2C19

Omeprazole has a moderate inhibitory effect on CYP2C19 (the main enzyme responsible for the metabolism of omeprazole). Therefore, the metabolism of concomitant drugs that are also metabolized by CYP2C19 may be reduced and the systemic exposure of these drugs may be increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol

In healthy volunteers, the use of omeprazole at a dose of 40 mg increased the maximum plasma concentration (Cmax) and AUC of cilostazol by 18% and 26%, respectively, and one of its active metabolites by 29% and 69%, respectively.

Monitoring of phenytoin plasma concentrations is recommended during the first two weeks after initiation of omeprazole treatment. If phenytoin dose adjustment has been made, monitoring and further dose adjustment should be carried out after discontinuation of omeprazole treatment.

Unknown mechanism

Saquinavir

Concomitant use of omeprazole with saquinavir/ritonavir resulted in an increase in plasma levels of saquinavir of approximately 70%, which was associated with good tolerability in HIV-infected patients.

Tacrolimus

Increased serum tacrolimus levels have been reported with concomitant use of omeprazole. Increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) is required and the tacrolimus dosage should be adjusted if necessary.

Methotrexate

Increased methotrexate levels have been reported in some patients when co-administered with PPIs. If high doses of methotrexate are required, temporary withdrawal of omeprazole should be considered.

Effect of other drugs on the pharmacokinetics of omeprazole

CYP2C19 and/or CYP3A4 inhibitors

Since omeprazole is metabolized by CYP2C19 and CYP3A4, drugs that inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may increase omeprazole serum levels by decreasing its metabolic rate. Concomitant use of voriconazole resulted in a more than two-fold increase in omeprazole AUC. Since high doses of omeprazole were well tolerated, dose adjustment of omeprazole is not usually necessary. However, dose adjustment should be considered in patients with severe hepatic impairment and in cases of long-term treatment.

CYP2C19 and/or CYP3A4 inducers

Drugs that induce the activity of CYP2C19 or CYP3A4 or both enzymes (such as rifampicin and St. John's wort) may lead to a decrease in serum levels of omeprazole as a result of an acceleration of its metabolic rate.

Application features

In the presence of any alarming symptom (e.g. significant weight loss not due to diet; frequent vomiting; dysphagia; vomiting with blood or melena) and in the presence of diagnosed or suspected gastric ulcer, malignant disease should be excluded, since taking the drug may mask its symptoms and delay the establishment of the correct diagnosis.

Concomitant use of atazanavir with PPIs is not recommended. If the combination of atazanavir with a PPI cannot be avoided, close clinical monitoring (e.g. viral load) is recommended in conjunction with an increase in the dose of atazanavir to 400 mg per 100 mg of ritonavir; the dose of omeprazole should not exceed 20 mg.

Omeprazole, like all drugs that inhibit the secretion of hydrochloric acid in the stomach, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into account in patients with low body weight or risk factors for reduced absorption of vitamin B12 during long-term therapy.

Omeprazole is an inhibitor of CYP2C19. When initiating or discontinuing treatment with omeprazole, the possibility of interactions with medicinal products metabolised by CYP2C19 should be considered. An interaction has been observed between clopidogrel and omeprazole. The clinical significance of this interaction remains unclear. As a precautionary measure, concomitant use of omeprazole and clopidogrel should be avoided.

Severe hypomagnesemia has been reported in patients taking PPIs, including omeprazole, for at least 3 months (in most cases of hypomagnesemia, patients had been taking the drug for about a year). Hypomagnesemia can manifest as serious symptoms such as fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmia. Hypomagnesemia can also be asymptomatic and may not be diagnosed in time. In most patients, the symptoms of hypomagnesemia disappear and the condition normalizes after the use of magnesium preparations and discontinuation of the PPI.

In patients who are planning to use PPIs for a long time or who are taking digoxin or other drugs that can cause magnesium depletion (e.g. diuretics), serum magnesium levels should be measured before starting PPI therapy and periodically during treatment.

PPIs, especially when used at high doses and for long periods (> 1 year), slightly increase the risk of fractures of the spine, wrist, and hip, especially in the elderly and in the presence of predisposing factors. Observational studies have shown that PPIs increase the overall risk of fractures by 10–40%. Part of the increased risk may be due to other factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and consume adequate amounts of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCL)

The use of PPIs can sometimes cause the development of PsA. If skin manifestations occur, especially in areas exposed to sunlight, and if these manifestations are accompanied by arthralgia, you should immediately consult a doctor and consider stopping omeprazole. A history of PsA that developed after the use of a PPI increases the risk of PsA with the use of other PPIs.

Acute tubulointerstitial nephritis (TIN) has been reported in patients taking omeprazole and may occur at any time during omeprazole therapy (see section 4.8). Acute tubulointerstitial nephritis may progress to renal failure. If TIN is suspected, omeprazole should be discontinued and appropriate treatment should be initiated immediately.

Impact on laboratory test results

Elevated chromogranin A (CgA) levels may interfere with the results of tests for neuroendocrine tumors. To obtain accurate results, omeprazole should be temporarily discontinued 5 days prior to CgA measurement. If CgA and gastrin levels have not returned to the reference range after initial measurements, these measurements should be repeated 14 days after discontinuation of PPI therapy.

Some children with chronic conditions require long-term treatment, although such treatment is not recommended.

Treatment with PPIs slightly increases the risk of gastrointestinal infections, such as those caused by Salmonella and Campylobacter, and in hospitalized patients, possibly also those caused by Clostridium difficile.

Patients who use the drug for a long period (especially when the treatment period lasts more than 1 year) require regular medical supervision.

Do not use in patients allergic to omeprazole. Omeprazole can cause serious skin reactions. Symptoms may include skin redness, blistering, rash. If an allergic reaction occurs, stop using the drug and seek immediate medical attention.

Omeprazole 20 mg capsules contain azorubine (E 122), which may cause allergic reactions.

The medicine contains sucrose, therefore, if the patient has been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

This medicinal product contains less than 1 mmol sodium/dose, i.e. essentially sodium-free.

Use during pregnancy or breastfeeding

Pregnancy

Results from prospective epidemiological studies indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn. Omeprazole can be used during pregnancy.

Breast-feeding

Omeprazole passes into breast milk, but the likelihood of affecting the child is low when used in therapeutic doses.

Fertility

Oral administration of the racemic mixture of omeprazole did not affect reproductive function in animal studies.

Ability to influence reaction speed when driving vehicles or other mechanisms

Omeprazole is unlikely to affect the ability to drive or use machines. Undesirable effects such as dizziness and visual disturbances may occur. If such disorders occur, patients should not drive or use machines.

Method of administration and doses

Doses

Adults

Treatment of duodenal ulcers

The recommended dose for patients with active duodenal ulcer is 20 mg omeprazole once daily. In most patients, duodenal ulcer heals within 2 weeks. For patients who do not fully heal after the initial course, further treatment for 2 weeks is recommended. For patients with a poor response to therapy, the recommended dose is 40 mg omeprazole daily; healing of the ulcer is usually achieved within 4 weeks.

Prevention of duodenal ulcer recurrence

For the prevention of recurrence of duodenal ulcers in patients with a negative test result for H. pylori, the recommended dose is 20 mg omeprazole once daily. For some patients, a daily dose of 10 mg may be sufficient. In case of insufficient therapy, the dose can be increased to 40 mg.

Treatment of stomach ulcers

The recommended dose is 20 mg omeprazole once daily. In most patients, gastric ulcers heal within 4 weeks. In patients who do not fully heal after the initial course, further treatment for 4 weeks is recommended. In severe cases or in cases of relapse, 40 mg omeprazole once daily is recommended; healing is usually achieved within 8 weeks.

Prevention of recurrence of stomach ulcers

For the prevention of relapse in patients with gastric ulcer and inadequate response to treatment, the recommended dose is 20 mg omeprazole once daily. If necessary, the dose may be increased to 40 mg omeprazole once daily.

Eradication of H. pylori in peptic ulcer

For the eradication of H. pylori, the choice of antibacterial drugs should take into account individual drug tolerance, relevant national and local characteristics, and treatment guidelines:

omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1000 mg, 2 times a day for 1 week, or

omeprazole 20 mg + clarithromycin 250 mg (if necessary – 500 mg) + metronidazole 400 mg (if necessary – 500 mg or tinidazole 500 mg) 2 times a day for 1 week, or

With each regimen, if the patient remains H. pylori positive, therapy can be repeated.

Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs), the recommended dose is 20 mg omeprazole once daily. In most patients, healing is achieved within 4 weeks. In patients who do not fully heal after the initial course, further treatment for 4 weeks is recommended.

Prevention of gastric and duodenal ulcers associated with NSAID use in patients at risk

For the prevention of NSAID-associated gastric and duodenal ulcers in patients at risk (age > 60 years, history of gastric and duodenal ulcers, history of upper gastrointestinal bleeding), the recommended dose is 20 mg omeprazole once daily.

Treatment of reflux esophagitis

The recommended dose is 20 mg omeprazole once daily. In most patients, healing is achieved within 4 weeks. In patients who do not fully heal after the initial course, further treatment for 4 weeks is recommended.

In patients with severe esophagitis, the recommended dose is 40 mg omeprazole once daily, and healing is usually achieved within 8 weeks.

Long-term treatment of patients with cured reflux esophagitis

For long-term treatment of patients with cured reflux esophagitis, the recommended dose is 10 mg omeprazole once daily. If necessary, the dose of omeprazole can be increased to 20-40 mg once daily.

Treatment of symptomatic gastroesophageal reflux disease

The recommended dose is 20 mg omeprazole once daily. For some patients, a daily dose of 10 mg may be sufficient, so the dose should be adjusted individually.

If symptoms persist after 4 weeks of treatment with omeprazole 20 mg daily, the patient should be further evaluated.

Treatment of Zollinger-Ellison syndrome

For patients with Zollinger-Ellison syndrome, the dose should be selected individually. Treatment is continued until clinical symptoms disappear. The recommended initial dose of omeprazole is 60 mg once daily. Observation of more than 90% of patients with severe disease and insufficient response to other treatments has shown the effectiveness of maintenance therapy with omeprazole in doses of 20–120 mg per day. Daily doses of omeprazole above 80 mg should be divided and administered in 2 doses.

Children

Children aged 1 year and over and weighing ≥ 10 kg

Treatment of reflux esophagitis

Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease

Dosage recommendations:

Reflux esophagitis: treatment duration is 4–8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease: duration of treatment is 2–4 weeks. If the desired result is not achieved after 2–4 weeks, the patient should be further examined.

Adolescents and children aged 4 and over

Treatment of duodenal ulcers caused by H. pylori.

Combination therapy should be prescribed taking into account national and local characteristics of bacterial resistance. The duration of treatment (7 to 14 days) and the appropriate use of antibacterial drugs should also be considered.

Treatment should be carried out under the supervision of a doctor.

Dosage recommendations:

Special populations

Kidney dysfunction

No dose adjustment is required for patients with renal impairment.

Liver dysfunction

For patients with impaired liver function, a daily dose of 10–20 mg is sufficient.

Elderly patients

Elderly patients do not require dose adjustment.

Method of application

It is recommended to take Omeprazole capsules in the morning, swallowing them whole with half a glass of water. The capsules should not be chewed or crushed.

The capsules can be opened and the contents swallowed directly with half a glass of water, or mixed in a slightly acidic liquid, such as any fruit juice, applesauce, or unsalted water. This mixture should be drunk immediately after preparation or within 30 minutes. The mixture should be shaken before taking and washed down with half a glass of water.

Alternatively, the capsules themselves can be dissolved and then swallowed with half a glass of water. The gastro-resistant granules should not be chewed.

The capsule should be taken immediately after opening the individual blister. The capsules should not be stored outside the blister for later use.

Children.

The drug should be used in children over 1 year of age and weighing more than 10 kg as prescribed by a doctor for reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease and in children over 4 years of age for the treatment of duodenal ulcers caused by H. pylori, under the supervision of a doctor.

Overdose

Data on the effects of omeprazole overdose in humans are very limited. Dosages up to 560 mg omeprazole have been described in the scientific literature, and there are isolated reports of single oral doses of 2400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhea, and headache have been reported. Apathy, depression, and confusion have also been reported in isolated cases.

However, all of these symptoms were transient, and no serious consequences were reported. The rate of drug elimination did not change (first-order kinetics) with increasing dose. Symptomatic treatment should be administered if necessary.

Adverse reactions

The most common side effects (in 1–10% of patients) are headache, abdominal pain, constipation, diarrhea, bloating, and nausea/vomiting.

The following adverse reactions have been identified or suspected during clinical trials or post-marketing use of omeprazole. They were not found to be dose-related. Adverse reactions are listed by system organ class. The frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available information).

Frequency	Adverse reaction
Blood and lymphatic system disorders
Rarely	Leukopenia, thrombocytopenia
Very rare	Agranulocytosis, pancytopenia
On the part of the immune system
Rarely	Hypersensitivity reactions, such as fever, angioedema and anaphylactic reaction/shock
Metabolic disorders
Rarely	Hyponatremia
Frequency unknown	Hypomagnesemia, severe hypomagnesemia can lead to hypocalcemia. Hypomagnesemia, which can cause hypokalemia
Mental disorders
Infrequently	Insomnia
Rarely	Agitation, confusion, depression
Very rare	Aggression, hallucinations
From the nervous system
Often	Headache
Infrequently	Dizziness, paresthesia, drowsiness
Rarely	Taste disturbance
From the organs of vision
Rarely	Blurred vision
From the side of the organs of speech Specifications Characteristics Active ingredient Omeprazole Adults Can ATC code A DRUGS AFFECTING THE DIGESTIVE SYSTEM AND METABOLISM; A02 DRUGS FOR THE TREATMENT OF ACID-RELATED DISEASES; A02B DRUGS FOR THE TREATMENT OF PEPTIC ULCER AND GASTRO-ESOPHAGIAL REFLUX DISEASE; A02B C Proton pump inhibitors; A02B C01 Omeprazole Country of manufacture Ukraine Diabetics Can Dosage 20 мг Drivers With caution For allergies With caution For children From the 1st year with a body weight of more than 10 kg Form Capsules Method of application Inside, solid Nursing Can Pregnant Can Primary packaging blister Producer Farmak JSC Quantity per package 30 pcs Vacation conditions By prescription Reviews There are no reviews for this product. + Add review Write a review Omeprazole capsules 0.02 g blister No. 30 My mark: Continue There are no reviews for this product, be the first to leave your review. Answers & questions Add your question and we will answer as soon as possible. + Ask a question Ask a question Add your question and we will answer as soon as possible. * Your question Continue No questions about this product, be the first and ask your question. You are watched new Sold out SVR Ampoule Hydra Restorative Concentrate 30 ml Распродано 0 1 704.20 грн. new Sold out Uriage Cica Daily Day Face Cream Cica Daily Restorative Concentrate 50 ml Распродано 0 1 278.60 грн. new Sold out Eyelid cream Zelenaya Apteka against swelling and bags under the eyes 15 ml Распродано 0 133.20 грн. new Sold out Ylang-ylang essential oil 5 ml Распродано 0 86.60 грн. new Hit Bibright tablets 250 mg blister No. 20 In stock 0 528.10 грн. Add to Cart new Sold out Apivita Aqua Beelicious moisturizing cream, comfortable, rich texture, 40 ml Распродано 0 1 046.00 грн. new Alpa Lesana Alpa Lesana alcohol solution for massage, baths and compresses 160 ml In stock 0 302.00 грн. Add to Cart new Sold out Apivita Sea Buckthorn Laurel Conditioner Tonic 150 ml Распродано 0 818.40 грн.