Instructions for Omeprazole capsules 20 mg No. 28
Warehouse
active ingredient: omeprazole;
1 capsule contains: omeprazole pellets, which contain the substance, calculated as omeprazole – 20 mg;
excipients: lactose anhydrous; hypromellose; hydroxypropylcellulose; sodium lauryl sulfate; hypromellose phthalate; sodium hydrogen phosphate, dodecahydrate; diethyl phthalate; sugar spheres (sucrose, corn starch);
capsule shell composition: azorubine, carmoisine (E 122), titanium dioxide (E 171), gelatin.
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules No. 2, pale pink body, bright pink cap. Capsule contents – white or almost white pellets, spherical in shape.
Pharmacological group
Capsules.
Main physical and chemical properties: hard gelatin capsules No. 2, pale pink body, bright pink cap. Capsule contents – white or almost white pellets, spherical in shape.
Pharmacological properties
Pharmacodynamics.
Omeprazole is a specific inhibitor of the proton pump of parietal cells. Due to this, the secretion of hydrochloric acid in the stomach is suppressed. The effect of inhibiting acid secretion is reversible. Omeprazole is a weak base that accumulates and turns into an active form in the acidic environment of parietal cells, where it inhibits H + , K + -ATPase, i.e. affects the final stage of gastric acid secretion.
Inhibition of secretion is dose-dependent and affects both basal and stimulated acid secretion, regardless of the type of stimulation. Omeprazole does not affect cholinergic and histaminergic receptors. As with treatment with H2-receptor blockers, treatment with omeprazole leads to a decrease in gastric acidity and, accordingly, a proportional increase in gastrin levels. The increase in gastrin levels is reversible. With a long course of treatment, the number of glandular cysts in the stomach may increase. These changes are physiological and are a consequence of a decrease in acidity. The process is benign and reversible. Reducing gastric acidity with proton pump inhibitors or other substances that suppress acidity may lead to an increase in the number of bacteria present in the gastrointestinal tract. Therefore, such treatment poses a risk of an increased incidence of gastrointestinal infections caused by Salmonella, Campylobacter and Clostridium difficile in hospitalized patients.
The effect on acid secretion is directly proportional to the area under the concentration-time curve (AUC) and is independent of the plasma concentration of omeprazole.
It has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori with the simultaneous use of omeprazole and antibiotics allows you to quickly relieve the symptoms of the disease, achieve a high degree of healing of the affected mucosa and stable long-term remission, and reduces the likelihood of bleeding from the digestive tract.
In reflux ulcerative esophagitis, normalization of acid exposure in the esophagus and maintenance of intragastric pH > 4 for 24 hours with a decrease in the destructive properties of gastric contents (inhibition of the transition of pepsinogen to pepsin) contributes to the reduction of symptoms and complete healing of esophageal damage (level). Omeprazole is highly effective in the treatment of severe and complicated forms of erosive and ulcerative esophagitis resistant to H2-blockers of histamine receptors. Long-term maintenance therapy prevents relapses of reflux esophagitis and reduces the risk of complications.
Pharmacokinetics.
The active substance omeprazole in the form of microgranules is in an enteric coating. After oral administration, the drug is rapidly and significantly absorbed from the digestive tract, but the bioavailability is no more than 50–55% (first-pass effect). Binding to plasma proteins (albumin and acid alpha 1-glycoprotein) is very high - 95%.
After a single dose of 20 mg of omeprazole, inhibition of gastric secretion occurs within the first hour, reaches a maximum after 2 hours and lasts for about 24 hours, the manifestation of the effect depends on the dose. The ability of parietal cells to produce hydrochloric acid is restored within 3-5 days after the end of therapy.
Distribution
The volume of distribution in healthy volunteers is 0.3 l/kg and is similar to that in patients with renal insufficiency. In elderly patients and patients with hepatic insufficiency, the volume of distribution may be slightly reduced. Omeprazole is approximately 95% bound to plasma proteins.
Metabolism and excretion
Omeprazole is completely metabolized by the cytochrome P450 (CYP) system. The main part of the metabolism depends on the polymorphic CYP2C19, responsible for the formation of hydroxyomeprazole, the main metabolite in blood plasma. The rest depends on another specific isoform of CYP3A4, responsible for the formation of omeprazole sulfone. Due to the high affinity of omeprazole for CYP2C19, there is a possibility of competitive inhibition and metabolic interaction with other CYP2C19 substrates. However, due to the low affinity for CYP3A4, omeprazole has no ability to inhibit the metabolism of other CYP3A4 substrates.
The drug is transformed in the liver with the formation of less than 6 metabolites, which are characterized by the practical absence of antisecretory activity.
Excreted mainly by the kidneys as metabolites (72–80%) and through the intestines (18–23%). The half-life is 0.5–1 hour (with normal liver function) or 3 hours (with chronic liver disease).
Total plasma clearance is 30 to 40 l/h after a single dose. The elimination half-life of omeprazole is usually less than 1 hour after both single and repeated oral administration once daily. The AUC of omeprazole increases with repeated administration. The increase is dose-dependent and provides a non-linear relationship between AUC and dose after repeated administration. This time- and dose-dependence is due to a decrease in first-pass metabolism and systemic clearance, which is probably due to inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulfone). Omeprazole is completely eliminated from plasma between doses without a tendency for accumulation with once-daily administration.
No effect of metabolites on gastric secretion has been found. Almost 80% of an orally administered dose of omeprazole is excreted as metabolites in the urine, the remainder in the feces, mainly by biliary secretion.
Poor metabolizers: Approximately 3% of the European population and 15% of the Asian population lack the enzyme CYP2C19 and are classified as “poor metabolizers”. In these individuals, the metabolism of omeprazole is probably catalyzed by CYP3A4. After repeated administration of omeprazole at a dose of 20 mg once daily, the mean area under the curve (AUC) in these patients increases 5-10-fold compared with individuals who do not lack the enzyme CYP2C19 (extensive metabolizers). The mean peak plasma concentrations are also 3-5-fold higher. However, these findings do not affect the dosage of omeprazole.
Patients with hepatic impairment: The metabolism of omeprazole is impaired in patients with hepatic dysfunction, resulting in an increase in AUC. There was no tendency for accumulation of omeprazole with once-daily dosing.
Patients with renal insufficiency: The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, remain unchanged in patients with renal insufficiency.
Elderly patients: The metabolic rate in elderly patients (75-79 years) is somewhat reduced.
Indication
Adults
Treatment of duodenal ulcers;
prevention of recurrence of duodenal ulcers;
treatment of benign gastric ulcer;
prevention of recurrence of stomach ulcers;
use in combination with appropriate antibiotics for eradication of Helicobacter pylori in peptic ulcer;
treatment of gastric and duodenal ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs);
prevention of gastric and duodenal ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at risk;
treatment of reflux esophagitis;
long-term treatment of patients with gastroesophageal reflux disease;
treatment of gastroesophageal reflux disease;
treatment of Zollinger-Ellison syndrome.
Children
Omeprazole should be used in children from 1 year of age with a body weight of more than 10 kg as prescribed by a doctor for reflux esophagitis, for the symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease; in children from 4 years of age - for the treatment of duodenal ulcers caused by H. pylori, under the supervision of a doctor (see the section "Method of administration and dosage").
Contraindication
Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.
Omeprazole, like other proton pump inhibitors (PPIs), should not be used concomitantly with nelfinavir and atazanovir.
Interaction with other medicinal products and other types of interactions
Effect of omeprazole on the pharmacokinetics of other drugs.
Absorption. Reduced gastric acidity during treatment with the drug may increase or decrease the absorption of drugs whose absorption depends on the pH of the gastric juice.
Ketoconazole, itraconazole, posaconazole, erlotinib
As with other drugs that inhibit gastric acidity, the absorption and therefore the clinical efficacy of such drugs as posaconazole, erlotinib, ketoconazole, itraconazole may be reduced during the use of omeprazole. The concomitant use of omeprazole with posaconazole and erlotinib should be avoided.
Plasma concentrations of nelfinavir and atazanavir are decreased when these drugs are co-administered with omeprazole. Co-administration of omeprazole and nelfinavir is contraindicated. Co-administration of omeprazole (40 mg once daily) decreased the mean exposure of nelfinavir by approximately 40%, and the mean exposure of the pharmacologically active metabolite M8 decreased by approximately 75-90%. The interaction may involve inhibition of CYP2C19. Co-administration of omeprazole (40 mg once daily) with the combination of atazanavir 300 mg/ritonavir 100 mg in healthy volunteers resulted in a 75% decrease in atazanavir exposure. Increasing the dose of atazanavir to 400 mg did not compensate for the effect of omeprazole on atazanavir exposure. Co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg in healthy volunteers resulted in a 30% decrease in atazanavir exposure compared to atazanavir 300 mg/ritonavir.
Digoxin
Concomitant use of omeprazole (20 mg daily) and digoxin increases the bioavailability of digoxin by 10%. Cases of toxicity due to digoxin have been reported rarely. However, caution should be exercised when prescribing high doses of omeprazole to elderly patients. Therapeutic monitoring of digoxin saturation should be intensified.
Clopidogrel
Concomitant use of omeprazole and clopidogrel should be avoided. With concomitant use, the average platelet aggregation is reduced by 47% (after 24 hours) and by 30% (on day 5).
Metabolism
Omeprazole inhibits CYP2C19, the main enzyme involved in the metabolism of omeprazole.
Therefore, the metabolism of concomitant drugs that are also metabolized by CYP2C19, such as diazepam, phenytoin, warfarin (R-warfarin) or other vitamin K antagonists and cilostazol may be slowed.
Monitoring of phenytoin plasma concentrations is recommended during the first two weeks after starting treatment with the drug, and if the phenytoin dose has been adjusted, monitoring and further dose adjustment should be performed after the end of treatment with the drug.
Monitoring of INR (international normalized ratio) is recommended in patients taking warfarin or other vitamin K antagonists; dose reduction of warfarin (or other vitamin K antagonist) may be necessary.
Concomitant use of 20 mg omeprazole per day does not alter coagulation time in patients receiving long-term warfarin.
There is evidence that the use of 40 mg of omeprazole increases the Cmax and AUC of cilostazol by 18% and 26%, respectively, and the Cmax and AUC of one of its active metabolites by 29% and 69%, respectively.
Omeprazole is also partially metabolized by CYP3A4, but does not inhibit this enzyme.
Thus, omeprazole does not affect the metabolism of drugs that are metabolized by CYP3A4, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.
Omeprazole at a dose of 20-40 mg per day does not significantly affect other CYP enzymes.
The mechanisms of interaction are unknown.
Tacrolimus
There is evidence that concomitant use of omeprazole increases serum levels of tacrolimus. Increased monitoring of tacrolimus levels and renal function (creatinine clearance) is required, and if necessary, the dose of tacrolimus should be adjusted.
Methotrexate
There are reports of increased methotrexate levels in some patients when co-administered with proton pump inhibitors. If high doses of methotrexate are required, temporary discontinuation of omeprazole should be considered.
Saquinavir.
There are reports of increased serum levels of other antiretroviral agents, such as saquinavir. There are also antiretroviral agents whose serum levels were unchanged when co-administered with omeprazole.
Effect of other drugs on the pharmacokinetics of omeprazole.
CYP2C19 and CYP3A4 inhibitors.
Metabolism: Since omeprazole is metabolized by CYP2C19 and CYP3A4, drugs that inhibit CYP2C19, CYP3A4, or both enzymes (such as clarithromycin and voriconazole) may increase omeprazole plasma levels by slowing its metabolism. Concomitant use of voriconazole resulted in a more than two-fold increase in omeprazole exposure. Since high doses of omeprazole were well tolerated, no dose adjustment is necessary during temporary co-administration. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
CYP2C19, CYP3A4 inducers.
Drugs that induce CYP2C19, CYP3A4, or both enzymes (such as rifampicin, St. John's wort) may cause a decrease in serum levels of omeprazole by accelerating its metabolism.
Application features
In the presence of any alarming symptoms (e.g. marked weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and in the presence or suspicion of gastric ulcer, malignancy should be excluded, as treatment with omeprazole may alleviate symptoms and delay diagnosis.
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 cachexia or risk factors for reduced absorption of vitamin B12 during long-term therapy.
Kidney dysfunction
Acute tubulointerstitial nephritis (ATIN) has been reported in patients taking omeprazole and may occur at any time during omeprazole therapy (see Adverse Reactions). Acute tubulointerstitial nephritis may progress to renal failure.
If OTIN is suspected, omeprazole should be discontinued and appropriate treatment should be initiated immediately.
Omeprazole is an inhibitor of CYP2C19. When starting or ending treatment with omeprazole, the possibility of its interaction with drugs metabolized by CYP2C19 should be considered. An interaction has been observed between clopidogrel and omeprazole. An interaction has been observed between clopidogrel and omeprazole. The clinical significance of this interaction has not been determined. The concomitant use of omeprazole and clopidogrel should be avoided.
Treatment with proton pump inhibitors slightly increases the risk of developing gastrointestinal infections caused by Salmonella and Campylobacter.
As with any long-term treatment, especially if the period exceeds 1 year, it is necessary to monitor the patient's condition.
Patients taking proton pump inhibitors, including omeprazole, may develop significant hypomagnesemia for at least 3 months (in most cases of hypomagnesemia, patients have been taking the drug for about 1 year). Hypomagnesemia can be suspected by such serious manifestations as fatigue, tetany, seizures, delirium, dizziness, ventricular arrhythmia. However, it should be remembered that in some cases the manifestations may be masked, which prevents timely recognition of such a complication. In most patients, the manifestations of hypomagnesemia disappear, and the condition normalizes after the use of magnesium preparations and the withdrawal of proton pump inhibitors.
In patients requiring long-term use of proton pump inhibitors and in patients concomitantly taking digoxin or other drugs that may cause hypomagnesemia (e.g. diuretics), magnesium levels should be checked before starting treatment and periodically during treatment.
Proton pump inhibitors, especially at high doses and for long periods (> 1 year), are associated with a small increase in the risk of hip, wrist, and spine fractures, mainly in elderly patients or in the presence of other risk factors. Observational studies suggest that proton pump inhibitors increase the risk of fractures by an average of 10-40%. In some cases, this is associated with the presence of other risk factors (osteoporosis). Patients at risk of osteoporosis should receive appropriate treatment and adequate intake of vitamin D and calcium.
The use of proton pump inhibitors can sometimes cause the appearance of subacute cutaneous lupus erythematosus. If skin manifestations accompanied by arthralgia occur, especially in areas exposed to sunlight, you should immediately consult a doctor and consider discontinuing omeprazole. A history of subacute cutaneous lupus erythematosus that developed after the use of proton pump inhibitors increases the risk of subacute cutaneous lupus erythematosus with the use of other proton pump inhibitors.
Do not use if you are allergic to omeprazole. Omeprazole can cause serious skin reactions. Symptoms may include: skin redness; blisters; rash.
If you experience an allergic reaction, discontinue use and seek medical attention immediately.
In some cases, treatment of chronic diseases in children may require longer use of the drug, although this is not recommended.
Omeprazole may increase the concentration of chromogranin A (CgA). Increased CgA concentration may affect the results of tests for the detection of neuroendocrine tumors. Therefore, it is necessary to temporarily stop taking omeprazole 5 days before the CgA test.
The medicinal product contains sucrose (in the sugar spheres) as an excipient, therefore patients with rare hereditary forms of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase insufficiency should not use it.
The medicinal product contains lactose as an excipient, therefore the drug should not be used in patients with galactose intolerance, lactase deficiency or glucose/galactose malabsorption.
The medicine contains carmoisine (E 122), which may cause allergic reactions.
Use during pregnancy or breastfeeding
There is evidence of no negative effects of omeprazole on pregnancy or the health of the fetus/newborn, so the drug can be used during pregnancy.
Omeprazole passes into breast milk, but its effects on the baby are unknown, so breastfeeding should be avoided during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
It is recommended to refrain from driving vehicles and potentially hazardous activities that require increased attention and speed of psychomotor reactions, as side effects such as dizziness and blurred vision are possible.
Method of administration and doses
Dosage for adults
Treatment and prevention of duodenal ulcers and benign gastric ulcers, including those associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs)
The recommended dose for patients with duodenal ulcer is 20 mg omeprazole once daily. In most patients, duodenal ulcers heal within 4 weeks. For patients who do not fully heal after the initial course, further treatment for 2 weeks is recommended. In severe or recurrent cases, 40 mg omeprazole per day is recommended; healing is usually achieved within 4 weeks.
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. If the therapy is insufficiently effective, the dose can be increased to 40 mg.
In the treatment of gastric 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 or recurrent cases, 40 mg omeprazole per day is recommended, and wound healing is achieved within 8 weeks.
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 once daily.
For the treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs, the recommended dose is 20 mg omeprazole once daily. In most patients, healing occurs within 4 weeks. In patients who do not fully heal after the initial course, further treatment for 4 weeks is recommended.
For the prevention of gastric and duodenal ulcers associated with the use of nonsteroidal anti-inflammatory drugs in patients at increased risk (age 60 years, history of gastric and duodenal ulcers, upper gastrointestinal bleeding) 100 mg of omeprazole once a day.
Eradication of H. pylori in peptic ulcer disease
For H. pylori eradication, the choice of antibiotics should take into account individual drug tolerance and comply with national, regional, and local characteristics and treatment recommendations.
Omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1000 mg 2 times a day for 1 week.
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.
Omeprazole 40 mg once daily + amoxicillin 500 mg + metronidazole 400 mg (if necessary 500 mg or tinidazole 500 mg) 3 times daily for 1 week.
Treatment of gastroesophageal disease, including reflux esophagitis
The recommended dose is 20 mg omeprazole once daily. Most patients recover within 4 weeks. For patients who do not fully recover after the initial course, further treatment for 4 weeks is recommended. For patients with severe esophagitis, 40 mg omeprazole daily is recommended, with recovery usually achieved within 8 weeks.
For long-term treatment of patients with gastroesophageal reflux disease, the recommended dose is 10 mg omeprazole once daily. If necessary, the dose may be increased to 20-40 mg omeprazole once daily.
In the treatment of symptoms of gastroesophageal reflux disease, the recommended dose is 20 mg omeprazole once daily. The dose should be adjusted individually. If the desired result is not achieved after 4 weeks of treatment with omeprazole 20 mg daily, the patient should be further examined.
Treatment of Zollinger-Ellison syndrome
For patients with Zollinger-Ellison syndrome, the dose should be selected individually. Treatment is continued until clinical manifestations of the disease disappear. The recommended initial dose is 60 mg of omeprazole once a day. Observation of more than 90% of patients with severe diseases and insufficient response to other treatments has shown the effectiveness of maintenance therapy in doses of 20-120 mg per day. Daily doses above 80 mg should be divided and administered in 2 doses.
Dosage for children
Children from 1 year of age with a body weight ≥ 10 kg
Treatment of reflux esophagitis
Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease
Dosage recommendations:
| Age | Body weight | Dosage |
| ≥ 1 year | 10–20 kg | 10 mg once daily. If necessary, the dose can be increased to 20 mg once daily. |
| Children weighing more than 20 kg | 20 mg once daily. If necessary, the dose may be increased to 40 mg once daily. | |
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.
Children from 4 years old and adolescents
Treatment of duodenal ulcers caused by H. pylori
The selection of appropriate combination therapy should be based on official national, regional and local guidelines on bacterial resistance, including the duration of treatment (7 to 14 days) and the appropriate use of antibacterial agents.
Treatment should be carried out under the supervision of a doctor.
Dosage recommendations:
| Body weight | Dosage |
| 15–30 kg | Omeprazole 10 mg / amoxicillin 25 mg / kg body weight + clarithromycin 7.5 mg / kg body weight. Take the drugs together 2 times a day for 1 week. |
| 31-40 kg | Omeprazole 20mg + amoxicillin 750mg + clarithromycin 7.5mg/kg body weight. Take the drugs together 2 times a day for 1 week. |
| > 40 kg | Omeprazole 20mg + amoxicillin 1000mg + clarithromycin 500mg. Take the drugs together 2 times a day for 1 week. |
* If a dose of 10 mg is necessary, use the drug in the appropriate dosage.
Special patient groups
Kidney dysfunction
No dose adjustment is required for patients with renal impairment (see Pharmacokinetics).
Liver dysfunction
For patients with impaired liver function, a daily dose of 10–20 mg is sufficient (see section "Pharmacokinetics").
Elderly patients (65 years)
No dose adjustment is required for elderly patients (see section "Pharmacokinetics").
Method of administration
It is recommended to take Omeprazole capsules in the morning, preferably before meals, without damaging the capsule (the capsules should not be chewed or broken) and with a small amount of water.
Take the capsule immediately after opening the individual blister. Do not store the capsule outside the blister for later use.
For patients with swallowing difficulties and for children who can drink or swallow semi-solid food
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 or apple puree, or in unsalted water. This mixture should be drunk within 30 minutes of preparation. The mixture should be shaken before taking and washed down with half a glass of water. Do not use milk or carbonated water.
You can also dissolve the capsules themselves and then swallow the contents with half a glass of water. The enteric-coated granules should not be chewed.
* If a dose of 10 mg is necessary, use the drug in the appropriate dosage.
Children. Omeprazole should be used in children from 1 year of age with a body weight of more than 10 kg as prescribed by a doctor for reflux esophagitis, for the symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease; in children from 4 years of age - for the treatment of duodenal ulcers caused by H. pylori, under the supervision of a doctor.
Overdose
Isolated cases of overdose have been described. A single dose of 560 mg of omeprazole has been reported, and there is also evidence of a single oral dose of up to 2400 mg of omeprazole, i.e. 120 times the usual recommended dose. However, all of the symptoms described are transient, and no serious consequences have been reported.
Symptoms of overdose: apathy, headache, tachycardia, nausea, vomiting, flatulence, diarrhea, dizziness, abdominal pain, depression, confusion.
There is no specific antidote. Omeprazole binds to plasma proteins, as a result of which it is poorly removed by dialysis. Treatment is symptomatic.
Side effects
Adverse reactions that may occur with omeprazole are listed by system organ class. None of the events were considered dose-related. The most common adverse reactions (1–10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting.
From the side of the hematopoiesis and lymphatic system: leukopenia, thrombocytopenia; agranulocytosis, pancytopenia.
Immune system disorders: Hypersensitivity reactions including fever, angioedema and anaphylactic reactions/shock.
Nutritional and metabolic disorders: hyponatremia; hypomagnesemia. Severe hypomagnesemia may lead to hypocalcemia; hypomagnesemia may also lead to hypokalemia.
Psychiatric: insomnia; agitation, confusion, depression; aggression, hallucinations.
Nervous system disorders: headache; dizziness, paresthesia, drowsiness; taste changes.
On the part of the organs of vision: blurred vision.
From the organs of hearing and balance: vertigo.
Respiratory, thoracic and mediastinal disorders: bronchospasm.
Gastrointestinal: abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, fundic gland polyps (benign).
Skin and subcutaneous tissue disorders: dermatitis, pruritus, rash, urticaria; alopecia, photosensitivity; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), subacute cutaneous lupus erythematosus.
Musculoskeletal, connective tissue and bone disorders: fracture of the hip, wrist or spine, arthralgia, myalgia; muscle weakness.
Urinary system disorders: interstitial nephritis.
Reproductive system and breast disorders: gynecomastia.
General disorders: malaise, peripheral edema, increased sweating.
Expiration date
3 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister, 1 or 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Address.
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
