Esomeprazole Canon - instructions for use, dose, side effects, contraindications

Excipients: low-substituted giprolase (hydroxypropylcellulose) 14 mg, corn pregelatinised corn starch 37.2 mg, silicon dioxide colloid 2 mg, mannitol 23 mg, sodium stearyl fumarate 2 mg, cellulose

microcrystalline 140 mg; composition of film shell: Fill transparent with 8 mg, including: [hypromellose (hydroxypropyl methyl cellulose) 6.4 mg, macrogol (polyethyl glycol) 1.6 mg]. Acrylic-From green 22 mg, including:

[methacrylic acid and ethyl acrylate copolymer [1: 1] 14.52 mg, silicon dioxide colloid 0.22 mg, sodium hydrogen carbonate 0.22 mg, sodium lauryl sulfate 0.11 mg, iron oxide yellow 0.154 mg, dye indigocarmine 0.176 mg, blue diamond dye 0.066 mg, talc 3.63 mg, titanium dioxide 2.904 mg]. Triethyl citrate 2 mg.

The dosage of 40 mg

1 tablet enteric-coated, film-coated shell, contains:active substance: esomeprazole magnesium dihydrate 43.6 mg, calculated as esomeprazole 40 mg;

Excipients: low-substituted giprolase (hydroxypropyl cellulose) 28 mg, corn pregelatinized corn starch 74.4 mg, silicon colloidal dioxide 4 mg, mannitol 46 mg, sodium stearyl fumarate 4 mg, microcrystalline cellulose 280 mg; composition of film shell: Fill transparent with 16 mg, including: [hypromellose (hydroxypropylmethylcellulose) 12.8 mg, macrogol (polyethyl glycol) 3.2 mg]. Acryl-From green 44 mg, including: [methacrylic acid and ethyl acrylate copolymer [1: 1] 29.04 mg, silicon dioxide colloid 0.44 mg, sodium hydrogen carbonate 0.44 mg,sodium lauryl sulfate 0.22 mg, iron oxide yellow 0.308 mg, indigo carmine dye 0.352 mg, diamond brilliant blue 0.132 mg, talc 7.26 mg, titanium dioxide 5.808 mg). Triethyl citrate 4 mg.

Description:

Round, biconvex tablets, covered with a film coat from light green to green with a bluish tinge. On a cross-section from almost white to light yellow color.

Pharmacotherapeutic group:The agent reducing the secretion of the glands of the stomach is an inhibitor of the proton pump.

ATX: & nbsp

A.02.B.C.05 Esomeprazole

Pharmacodynamics:

Esomeprazole is S-isomer of omeprazole and reduces the secretion of hydrochloric acid in the stomach by specifically inhibiting the proton pump in parietal cells of the stomach. S- and R-isomers of omeprazole have a similar

pharmacodynamic activity. Mechanism of action

Esomeprazole is a weak base that transforms into an active form in a highly acidic environment of the secretory tubules of the parietal cells of the gastric mucosa and inhibits the proton pump - the enzyme H + / K +

- ATPase, with the inhibition of both basal and stimulated secretion of hydrochloric acid.

Effect on the secretion of hydrochloric acid in the stomach

After oral administration of 20 mg or 40 mg, the effect of esomeprazole develops within 1 hour. With daily intake of the drug for 5 days at a dose of 20 mg once a day, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is reduced by 90% (when measuring the acid concentration 6-7 hours after taking the drug on the 5th day of therapy).

In patients with gastroesophageal reflux disease (GERD) and clinical symptoms after 5 days of daily oral esomeprazole at a dose of 20 mg or 40 mg, the intragastric pH above 4.0 was maintained for an average of 13 and 17 hours out of 24 hours. Against the background of taking esomeprazole at a dose of 20 mg per day, the value of intragastric pH above 4.0 was maintained at least 8, 12 and 16 hours in 76%, 54% and 24% of patients, respectively.

A correlation was found between plasma concentration in the plasma and inhibition of hydrochloric acid secretion (the concentration AUC - area under the curve "concentration - time". The therapeutic effect achieved as a result of inhibition secretion of hydrochloric acid

When taking the drug at a dose of 40 mg, the healing of reflux esophagitis occurs in approximately 78% of patients after 4 weeks of therapy and in 93% of patients after 8 weeks of therapy.

Treatment with esomeprazole at a dose of 20 mg twice a day in combination with

appropriate antibiotics for one week leads to successful eradication Helicobacter pylori in about 90% of patients. Patients with uncomplicated peptic ulcer after a weekly eradication course do not need subsequent monotherapy with drugs that reduce the secretion of the glands of the stomach, to treat ulcers and eliminate symptoms.

The efficacy of esomeprazole in bleeding from peptic ulcers confirmed endoscopically is shown.

Other effects associated with inhibition of hydrochloric acid secretion During treatment with drugs that reduce the secretion of the gland of the stomach, the concentration of gastrin in the plasma increases as a result of a decrease in the secretion of hydrochloric acid. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA). Increase in concentration CgA can influence the results of examinations for the detection of neuroendocrine tumors.To prevent this effect, it is necessary to temporarily stop taking esomeprazole 5 days before the concentration test CgA.

Patients who received long-term esomeprazole, there was an increase in the number of enterochromaffin-like cells, probably due to an increase in the concentration of gastrin in the plasma.

In patients taking drugs that reduce the secretion of the glands of the stomach, for a long period of time, the formation of glandular cysts in the stomach is more often noted. These phenomena are caused by physiological changes as a result of pronounced inhibition of the secretion of hydrochloric acid. Cysts are benign and undergo reverse development.

The use of drugs that inhibit the secretion of hydrochloric acid in the stomach, including proton pump inhibitors, is accompanied by an increase in the content of the microbial flora in the stomach, normally present in the gastrointestinal tract. Application inhibitors of the proton pump can lead to an insignificant

increased risk of infectious diseasesethe intestinal tract,

caused by bacteria of the genus Salmonella spp. and Campylibacter spp and, probably,

Clostridium difficile in hospitalized patients.

In two comparative studies with ranitidine esomeprazole showed better efficacy in the treatment of gastric ulcers in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2).

Pharmacokinetics:

Absorption and distribution

Esomeprazole is unstable in an acidic environment, so for oral use, tablets are coated with enteric-coated membranes. In conditions in vivo Only a small fraction of esomeprazole is converted into Risomer.

Eating slows and reduces absorption of esomeprazole in the stomach, but this does not have a significant effect on the inhibition of hydrochloric acid secretion.

The drug is rapidly absorbed: the maximum concentration (C_mOh) in the plasma is achieved 1-2 hours after admission. Absolute bioavailability of esomeprazole after a single dose of 40 mg is 64% and increases to 89% on the background of daily administration once a day. For a dose of 20 mg of esomeprazole, these values are 50% and 68%, respectively.The volume of distribution at equilibrium concentration in healthy people is approximately 0.22 l / kg body weight. Esomeprazole binds to plasma proteins by 97%.

Metabolism and excretion

Esomeprazole undergoes a metabolism involving isoenzymes of the cytochrome P450 system. The main part is metabolized with the participation of a specific polymorphic isoenzyme CYP2C19, thus forming hydroxylated and demethylated metabolites of esomeprazole. Metabolism of the remainder is carried out isoferment CYP3A4, at This forms the sulfo derivative of esomeprazole, which is the main metabolite, determined in plasma.

The parameters given below mainly reflect the nature of pharmacokinetics in patients with increased isoenzyme activity CYP2C19.

The total clearance is approximately 17 l / h after a single dose and 9 l / h - after repeated administration. The half-life (T1/2) is 1.3 hours with a systematic admission once a day. AUC increases with repeated use of esomeprazole. Dose-dependent increase AUC with repeated administration of esomeprazole is nonlinear,which is a consequence of a decrease in metabolism during the "first passage" through the liver, as well as a decrease in systemic clearance, probably caused by inhibition of isofermite CYP2C19 with esomeprazole and / or its sulfo derivative.

With daily intake once a day esomeprazole completely removed from the blood plasma during a break between doses and does not cumulate.

The main metabolites of esomeprazole do not affect the secretion of hydrochloric acid in the stomach. When administered orally, up to 80% of the dose is excreted as metabolites by the kidneys, the other part by the intestine. In urine, less than 1% of unchanged esomeprazole is found.

Peculiarities of pharmacokinetics the some patient groups Approximately 2.9 ± 1.5% of the population has decreased isoenzyme activity CYP2C19. In such patients, the metabolism of esomeprazole is mainly carried out using isoenzyme CYP3A4. With the systematic administration of 40 mg of esomeprazole, once a day, the mean AUC 100% higher than this parameter in patients with increased isoenzyme activity CYP2C19. Mean values of maximum plasma concentrations in patients with reduced isoenzyme activity increased by approximately 60%. The waspsdo not affect the dose and a method of using esomeprazole. In elderly patients (71-80 years) metabolism of esomeprazole is not undergoes significant changes. After a single dose of 40 mg esomeprazole, the mean AUC in women it is 30% higher than that of men. With daily intake of the drug once a day, there are no differences in pharmacokinetics in men and women. These features do not affect the dose and method of use of esomeprazole.

In patients with hepatic insufficiency of mild to moderate severity, esomeprazole metabolism may be impaired. In patients with severe hepatic insufficiency, the metabolic rate is reduced, which leads to an increase in the value AUC for esomeprazole 2 times.

The study of pharmacokinetics in patients with renal insufficiency was not carried out.

Because the kidneys exclude not the most esomeprazole, but its metabolite, it can be assumed that the metabolism of esomeprazole in patients with renal insufficiency does not change.

In children aged 12-18 years after repeated administration of 20 mg and 40 mg of esomeprazole, the value AUC and time to reach the maximum concentration (TC_mOh) in blood plasma was similar to the value AUC and TS_mOh in adults.

Indications:

Gastroesophageal reflux disease (GERD)

Treatment of erosive reflux esophagitis:

- Long-term maintenance treatment after healing of erosive reflux esophagitis, prevention of relapses;

- Symptomatic treatment of GERD.

Stomach ulcer and duodenal ulcer

in combination therapy:

- Treatment of duodenal ulcers associated with Helicobacter pylori;

- Prevention of recurrences of peptic ulcers associated with Helicobacter pylori.

Long-term acid-suppressing therapy in patients who underwent bleeding from a peptic ulcer (after intravenous administration of drugs that reduce the secretion of the glands of the stomach, for the prevention of recurrence).

Patients taking long-term NSAIDs

- Treatment of gastric ulcers caused by the intake of NSAIDs;

- Prevention of gastric ulcer and duodenal ulcer caused by the intake of NSAIDs in patients at risk.

Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the glands of the stomach, including idiopathic hypersecretion.

Contraindications:

- increased sensitivity to esomeprazole, substituted benzimidazoles or other components of the drug;

- Children under 12 years of age (due to the lack of data on the effectiveness and safety of the drug in this group of patients);

- children age from 12 to 18 years for all indications, except for GERD;

- simultaneous reception with atazanavir and nelfinavir.

Carefully:Severe renal failure (limited experience).

Pregnancy and lactation:Currently, there is insufficient data on the use of esomeprazole during pregnancy. Results of epidemiological studies esomeprazole, which is a racemic mixture, showed absence of fetotoxic action or nfruiting development. In animal studies, no direct or indirect adverse effects on the development of the embryo or fetus, either with the administration of esomeprazole or with the administration of the racemic mixture, have been detected. Prescribe the drug to pregnant women only if the expected benefit to the mother exceeds the potential risk to the fetus. It is not known whether esomeprazole with breast milk, so the drug should not be used during breastfeeding.

Dosing and Administration:

Inside. The tablet should be swallowed whole, not liquid, squeezed with enough water.

Adults and children from the age of 12 Gastroesophageal reflux disease

Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks.

An additional 4-week course of treatment is recommended in cases when, after the first course, the healing of esophagitis does not occur or the symptoms persist.

Long-term maintenance treatment after healing of erosive reflux-esophagitis. prevention of relapses: 20 mg once daily. Symptomatic treatment of GERD: 20 mg once a day to patients without esophagitis. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient should be carried out. After eliminating the symptoms, you can go to the drug regimen "if necessary"

- 20 mg once a day with the resumption of symptoms. For patients taking NSAIDs and those at risk of developing gastric or duodenal ulcers, treatment is not recommended if necessary.

Adults

Stomach ulcer and duodenal ulcer As part of combination therapy for eradication Helicobacter pylori:

- treatment of duodenal ulcers associated with Helicobacter pylori: Esomeprazole Canon 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg. All drugs are taken 2 times a day for 1 week.

- prevention of recurrences of peptic ulcers associated with Helicobacter pylori: Esomeprazole Canon 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg. All drugs are taken 2 times a day for

1 of the week.

Long-term acid-suppressing therapy in patients who have undergone bleeding from peptic ulcer (after intravenous application drugs that reduce the secretion of the glands of the stomach, for prevention relapse): Esomeprazole Canon 40 mg 1 time per day for 4 weeks after intravenous use of drugs that reduce the secretion of the glands of the stomach.

Patients taking long-term NSAIDs

Treatment of gastric ulcers caused by the intake of NSAIDs: Esomeprazole Canon 20 mg once daily; duration of treatment 4-8 weeks.

Prevention of gastric ulcer and duodenal ulcer caused by with NSAIDs: Esomeprazole Canon 20 mg once daily.

Conditions characterized by abnormal hypersecretion of the glands of the stomach, including Zollinger-Ellison syndrome and idiopathic hypersecretion: The recommended initial dose of the drug is Esomeprazole Canon 40 mg 2 times a day. Then the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is an experience of using 80 to 160 mg of esomeprazole per day, when taking the drug more than 80 mg per day, it is recommended to divide the necessary dose into

2 reception. Renal insufficiency: dose adjustment Esomeprazole The canon is not required. However, experience with esomeprazole in patients with severe renal failure is limited, in this regard, with prescribing this patient should be respected caution. Liver failure: with hepatic insufficiency of mild and moderate severity, dose correction is not required. For patients with severe hepatic insufficiency, the maximum daily dose should not exceed 20 mg.

Older patients: dosage adjustment is not required.

Side effects:

Classification of frequency of development of side effects of the World

Health Organization (WHO):

very often -> 1/10 appointments (> 10%)

often from> 1/100 to <1/10 of prescriptions (> 1% and <10%)

infrequently - from> 1/1000 to <1/100 of prescriptions (> 0.1% and <1%)

rarely from> 1/10000 to <1/1000 appointments (> 0.01% and <0.1%)

very rarely - <1/10000 prescriptions (<0.01%)

frequency is unknown - can not be estimated from the available data. In each group, undesirable effects are presented in order of decreasing severity.

Disturbances from the nervous system Often: headache.

Infrequent: drowsiness, insomnia, dizziness, paresthesia.

Rarely: agitation, confusion, depression.

Very rarely: aggressive behavior, hallucinations.

Disturbances from the respiratory system Rarely: bronchospasm.

Disorders from the digestive system

Often: abdominal pain, diarrhea, flatulence, nausea, vomiting, constipation.

Infrequent: dry mouth, increased activity of "renal" enzymes.

Rarely: stomatitis, candidiasis gastrointestinal tract (GIT), hepatitis (with jaundice or without).

Very rarely: liver failure, hepatic encephalopathy in patients with a history of liver disease, microscopic colitis. Disorders from the kidneys and urinary tract Very rarely: interstitial nephritis.

Frequency unknown: renal failure.

Disorders from the reproductive system Very rarely: gynecomastia.

Musculoskeletal system disorders Rarely: arthralgia, myalgia.

Very rarely: muscle weakness.

The frequency is unknown: fractures of the neck of the hip, bones of the wrist, vertebrae. Disturbances from the skin

Infrequent: itching, rash, hives, dermatitis, peripheral edema.

Rarely: alopecia, photosensitivity, malaise, increased

sweating.

Very rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Violations from the organs of hematopoiesis Rarely: leukopenia, thrombocytopenia.

Very rarely: agranulocytosis, pancytopenia.

Impaired sensory organs Infrequent: blurred vision.

Rarely: a violation of taste.

Allergic reactions

Rarely: hypersensitivity reactions (eg, fever, angioedema, anaphylactic reaction / anaphylactic shock).

Laboratory and instrumental data Rarely: hyponatremia.

Very rarely: hypomagnesemia, hypocalcemia due to severe

hypomagnesemia, hypokalemia due to severe hypomagnesemia.

Overdose:

Currently, cases of overdose of the drug esomeprazole are described extremely rarely. Oral administration of esomeprazole at a dose of 280 mg was accompanied by general weakness and symptoms from the gastrointestinal tract. A single dose of 80 mg of esomeprazole did not cause any negative consequences.

Treatment: The specific antidote is unknown. Hemodialysis is ineffective. In case of an overdose, symptomatic and general maintenance therapy is recommended.

Interaction:

The effect of esomeprazole on the pharmacokinetics of other drugs drugs

The decrease in the secretion of hydrochloric acid in the stomach against the background of treatment with esomeprazole and other inhibitors of the proton pump can lead to a change in the absorption of drugs, the absorption of which depends on the acidity of the medium. Like antacids and other drugs that reduce the acidity of gastric juice, the use of esomeprazole can lead to a decrease in the absorption of ketoconazole, itraconazole and erlotinib, and an increase in the absorption of such drugs as digoxin.

Simultaneous reception of esomeprazole at a dose of 20 mg once a day and digoxin increases the bioavailability of digoxin by 10% (bioavailability of digoxin increased by an amountup to 30% in two of 10 patients).

It is known about the interaction of esomeprazole with some antiretroviral drugs. The mechanisms and the clinical significance of these interactions are not always known. Increase in pH with esomeprazole therapy

may affect the absorption of antiretroviral drugs. Also

possible interaction on the level of isoenzyme FROMYP2S19.

When co-prescribing esomeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, against the background of therapy with esomeprazole, there is a decrease in their concentration in the serum. Therefore, their simultaneous application is not recommended.

The simultaneous use of esomeprazole 40 mg once daily and atazanavir 300 mg / ritonavir 100 mg in healthy volunteers resulted in a significant decrease in the bioavailability of atazanavir (AUC, as well as the maximum and minimum concentrations decreased by approximately 75%). An increase in the dose of atazanavir to 400 mg did not compensate for the effect of esomeprazole on the bioavailability of atazanavir.

With the simultaneous use of esomeprazole and saquinavir, an increase in the concentration of saquinavir in serum was noted; When used with some other antiretroviral drugs, their concentration did not change.Given the similar pharmacokinetic and pharmacodynamic properties of omeprazole and esomeprazole, the combined use of esomeprazole with antiretroviral drugs, such as atazanavir and nelfinavir, Not recommended.

Esomeprazole inhibits isoenzyme CYP2C19 - the main enzyme involved in its metabolism. Accordingly, the joint use of esomeprazole with other drugs in the metabolism of which isoenzyme participates CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin , etc., can lead to an increase in the concentrations of these drugs in the plasma, which, in turn, may require a dose reduction. It is especially important to remember this interaction when prescribing the drug Esomeprazole Canon in "if necessary" mode. When co-administered 30 mg of esomeprazole and diazepam, which is a substrate of the isoenzyme CYP2C19, there is a decrease in clearance of diazepam by 45%.The administration of esomeprazole at a dose of 40 mg resulted in an increase in the residual concentration of phenytoin in patients with epilepsy by 13%. In this regard, it is recommended to monitor the concentrations of phenytoin in the plasma at the beginning of treatment with esomeprazole and when it is withdrawn.

Simultaneous use of esomeprazole in a dose of 40 mg leads to an increase in the concentration of phenytoin in the blood plasma in patients with epilepsy by 13%.

It is recommended to monitor the concentration of phenytonin in the blood plasma at the beginning of therapy with esomeprazole and when it is withdrawn.

When using esomeprazole in a dose of 40 mg once a day increases AUC and TSmah voriconazole (substrate isoenzyme CYP2C19) by 15% and 41% respectively.

The simultaneous administration of warfarin and 40 mg of esomeprazole does not lead to a change in coagulation time in patients taking long-term warfarin. However, several cases of a clinically significant increase in the INR index (an international normalized ratio) have been reported with the combined use of warfarin and esomeprazole. It is recommended to monitor the INR at the beginning and after the end of the joint use of esomeprazole and warfarin or other coumarin derivatives.

Joint use of cisapride with 40 mg of esomeprazole leads to an increase in the pharmacokinetic parameters of cisapride in healthy volunteers: AUC - by 18% and T1/2 by 26%, for one of the active metabolites of cytostasol, the increase was 29% and 69%, respectively.Simultaneous use of esomeprazole in a dose of 40 mg with cisapride increases the pharmacokinetic parameters of cisapride in healthy volunteers: AUC by 32% and T1/2 by 31%, however, C_max while not significantly changed.

Slight lengthening of the interval QT, which was observed with monotherapy with cisapride, did not increase with addition of esomeprazole.

Some patients reported increased concentrations of methotrexate in serum on the background of simultaneous use with proton pump inhibitors. When high doses of methotrexate are used

consider the possibility of temporary withdrawal of esomeprazole.

Esomeprazole does not cause clinically significant changes in the pharmacokinetics of amoxicillin and quinidine.

Studies evaluating the short-term joint use of esomeprazole and naproxen or rofecoxib have not revealed a clinically significant pharmacokinetic interaction.

Simultaneous short-term use of esomeprazole and naproxen or rofecoxib did not reveal clinically significant pharmacokinetic interaction.

In the clinical study, the interaction was studied using clopidogrel (300 mg loading dose, then 75 mg / day) with esomeprazole (80 mg) at the same time, at the same time for 5 days.The activity of the thiol metabolite (active metabolite) of clopidogrel was reduced by 46% (1st day of therapy) and 42% (5th day of therapy), with the use of clopidogrel and omeprazole at the same time. When taking clopidogrel and esomeprazole at one time, the average suppression of platelet aggregation (IRA) was reduced by 47% (within 24 hours of therapy) and 30% (5th day of therapy).

According to the results of another study: esomeprazole when used with clopidogrel not at one time, at different times, does not have an inhibitory effect on the isoenzyme CYP2C19. In the studies, conflicting evidence of clinical manifestations of interaction with clopidogrel in the cardiovascular system was recorded.

With simultaneous application with tacrolimus, an increase in serum concentrations of tacrolimus is possible.

The effect of drugs on the pharmacokinetics of esomeprazole In the metabolism of esomeprazole, isozymes participate CYP2C19 and CYP3A4. Joint use of esomeprazole with clarithromycin (500 mg 2 times in

day), which inhibits the isoenzyme value AUC esomeprazole 2 times.

Joint use of esomeprazole and a combined inhibitor of isoenzyme CYP3A4 and CYP2C19, for example, voriconazole, can lead to more than 2-fold increase in the value AUC for esomeprazole. As a rule, in such cases, do not need to adjust the dose of esomeprazole.

Medicines inducing isoenzymes CYP2C19 and CYP3A4, such as rifampicin and preparations of St. John's wort penetrated, with simultaneous use with esomeprazole may lead to a decrease in the concentration of esomeprazole in the blood plasma by accelerating the metabolism of esomeprazole.

Special instructions:

In the presence of any anxiety symptoms (for example, such as significant spontaneous weight loss, repeated vomiting, dysphagia, vomiting with a trace of blood or melena), and if there is a stomach ulcer (or suspected gastric ulcer), the presence of a malignant tumor treatment with esomeprazole may lead to a smoothing of the symptoms and delay the diagnosis. Patients taking the drug for a long period (especially more than a year) should be under regular medical supervision. Patients receiving esomeprazole "if necessary," should be instructed to contact their physician when changing the nature of the symptoms.Taking into account the fluctuations in the plasma esomeprazole concentration when the therapy is administered "if necessary", the interaction of the drug with other drugs should be taken into account (see the section "Interaction with other drugs and other types of drug interactions").

When using esomeprazole for eradication Helicobacter pylori must

The possibility of drug interactions for all

components of triple therapy. Clarithromycin is a powerful

inhibitor of isoenzyme CYP3A4, so when applying

Eradication therapy for patients receiving other drugs,

metabolized with the participation of isoenzyme CYP3A4 (e.g.,

cisapride), possible contraindications and

interaction of clarithromycin with these drugs.

When using proton pump inhibitors, especially when they are

use in large doses and for an extended period

(more than 1 year) there is a risk of a fracture of the neck of the hip, bones

wrists and vertebrae (especially in elderly patients). It is also noted

the formation of glandular cysts in the stomach, a decrease in the absorption of vitamin B12,

development of hypomagnesemia.

Effect on the ability to drive transp. cf. and fur:

During the treatment, dizziness, blurred vision and drowsiness may occur, therefore, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets are enteric, film-coated 20 mg and 40 mg.

Packaging:By 7, 10 or 14 tablets in a contour mesh box made of PVC film, PVC / PVC film, PVC / PCTFE film or aluminum multilayer foil and aluminum lacquered aluminum foil. For 1, 2, 4 contour squares for 7, 10 or 14 tablets with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003017

Date of registration:02.06.2015

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp02.06.2015

Illustrated instructions

Instructions

Esomeprazole Canon (Ezomeprazole Canon)