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

core: sugar grits (sucrose 8.1 mg, corn starch 0.7 mg) 8.8 mg; hypromellose 3cp 8.7 mg; giprolose 6.6 mg; polysorbate 80 1.9 mg; talc 10.9 mg; shell: magnesium stearate 0.9 mg; methacrylic acid and ethyl acrylate copolymer [1: 1], 30% dispersion 28.5 mg; triethyl citrate 8.5 mg; glyceryl monostearate 4.3 mg; stearoyl macrogol glycerides 0.3 mg; cellulose microcrystalline (180 microns) 209.1 mg; cellulose microcrystalline (100 microns) 108.7 mg; sodium stearyl fumarate 1.1 mg; Opadrai® pink 5B94241 (hypromellose 60%, titanium dioxide 31.29%, macrogol 8%, iron dye red oxide 0.4%, iron dye oxide 0.31% yellow oxide) 21.0 mg. Tablets are enteric-soluble. 40 mg

Active substance: esomeprazole magnesium dihydrate - 43.4 mg (in terms of esomeprazole

- 40.0 mg).

Excipients:

core: sugar grits (sucrose 16.1 mg, corn starch 1.4 mg) 17.5 mg; Hypromellose ZSR 17.3 mg; giprolose 13.1 mg; polysorbate 80 3.9 mg; talc 21.8 mg; shell: magnesium stearate 1.9 mg; methacrylic acid and ethyl acrylate copolymer [1: 1], 30% dispersion 57.0 mg; triethyl citrate 17.1 mg; glyceryl monostearate 8.6 mg; stearoyl macroglycerides 0.6 mg; cellulose microcrystalline (180 microns) 257.1 mg; cellulose microcrystalline (100 microns) 139.2 mg; sodium stearyl fumarate 1.5 mg;

Opadrai® pink 5B94243 (hypromellose 60%, gitanium dioxide 29.83%, macrogol 8%, iron dye oxide red 2.13%, iron dye oxide black 0.04%) 24.0 mg.

Description:

Tablets of 20 mg: biconvex oval tablet of light pink color, covered with a shell, engraved "20" on one side.

Tablets 40 mg: biconvex oval shaped tablets of pink color, covered with a shell, engraved "40" on one side.

Pharmacotherapeutic group:The iron of the stomach secretion is a reducing agent - a proton pump inhibitor.

ATX: & nbsp

A.02.B.C.05 Esomeprazole

Pharmacodynamics:

Esomeprazole is S-isomer of omeprazole. The drug reduces the secretion of hydrochloric acid in the stomach due to specific target mechanisms of action. The drug is a specific inhibitor of the proton pump in parietal cells of the gastric mucosa. Sisomer and R-isomer of omeprazole have similar pharmacodynamic activity.

Localization and mechanism of action

Esomeprazole is a weak base; the drug is concentrated and passes into the active form in the sharply acidic environment of the secretory tubules of parietal cells, where it inhibits the proton pump, the ATPase enzyme. Esomeprazole inhibits both basal and stimulated gastric secretion.

Effect on secretion of acid in the stomach

After taking esomeprazole inside at a dose of 20 mg or 40 mg, the therapeutic effect develops within 1 hour. With daily intake of the drug for 5 days to 20 mg

1 once a day, the average maximum release of hydrochloric acid after stimulation with pentagastrin is reduced by 90% when measured 6-7 hours after taking the dose on the 5th day of treatment.

In patients with symptomatic GERD (gastroesophageal reflux disease), after 5 days of daily intake of esomeprazole at a dose of 20 mg or 40 mg, the pH in the stomach was higher

4,0 for an average of 13 and 17 hours per day, respectively. Among patients taking the drug at a dose of 20 mg per day, maintaining pH in the stomach at a higher level

4,0 during 8. 12 and 16 hours was achieved in 76%, 54% and 24% of patients, respectively. When using 40 mg of esomeprazole per day, this ratio was 97%, 92% and 56%, respectively.

There is a correlation between the concentration of the drug in plasma and inhibition of hydrochloric acid secretion (to estimate the concentration, the parameter AUC - area under the curve "concentration - time").

Therapeutic effect of reducing acidity

When taking esomeprazole at a dose of 40 mg per day, the treatment of reflux esophagitis occurs in approximately 78% of patients after 4 weeks of treatment and in 93% after 8 weeks of treatment.

Treatment with esomeprazole at a dose of 20 mg twice a day in combination with the appropriate antibiotics for one week resulted in successful eradication of H. pylori in about 90% of patients.

Patients with an uncomplicated duodenal ulcer after a week of eradication treatment do not need follow-up monotherapy with antisecretory drugs to effectively treat ulcers and eliminate symptoms.

The efficacy of esomeprazole in bleeding from peptic ulcers has been shown in a study in patients with peptic ulcer bleeding confirmed endoscopically.

Other effects of reduced acidity

During treatment with antisecretory drugs, the content of gastrin in the blood plasma increases as a result of decreased acid secretion. Due to a decrease in the acidity of the gastric juice, the level of chromogranin A (CgA).

It is possible that an increase in the number of enterochromaffin-like cells is associated with an increase in the concentration of gastrin in the blood serum, which is observed in some patients with prolonged treatment with esomeprazole.

During long-term treatment with drugs that reduce the secretion of the glands of the stomach, there was a slight increase in the incidence of glandular cysts in the stomach.These phenomena are caused by physiological changes as a result of pronounced inhibition of the secretion of hydrochloric acid. Cysts are benign in nature and undergo reverse development. Reduction of the acidity of gastric juice due to any drugs, including proton pump inhibitors, leads to an increase in the number of bacteria in the stomach (which are usually present in the gastrointestinal tract). Treatment with proton pump inhibitors can lead to a slight increase in the risk of gastrointestinal infections, such as Salmonella spp. and

Campylobacter spp.

In two comparative studies with ranitidine as an active comparator, esomeprazole showed greater efficacy in the treatment of peptic 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 of tablets containing granules of the drug, the shell of which is resistant to the action of gastric juice. In conditions in vivo Only a small fraction of esomeprazole is converted into Risomer. Esomeprazole quickly absorbed, the maximum concentration in the cryopreservation plasma is reached approximately in 1-2 hours after administration. Absolute bioavailability after a single dose of 40 mg is 64% and increases to 89% against repeated use once a day. For a dose of 20 mg of esomeprazole, these values are 50% and 68%, respectively. The volume of distribution at an equilibrium concentration in healthy subjects is approximately 0.22 L / kg body weight. Binding to plasma proteins is 97%. Eating slows and reduces the absorption of esomeprazole in the stomach, but this does not significantly affect its effectiveness in inhibiting the secretion of hydrochloric acid.

Metabolism and excretion.

Esomeprazole is completely metabolized with the participation of enzymes of the cytochrome P450 system (CYP). The main part is metabolized with the participation of a polymorphous isoenzyme form CYP2C19, thus formed hydroxylated and desmethylated metabolites of esomeprazole. Metabolism of the rest of the drug is due to another specific isoenzyme CYP3A4, thus forming a sulfo derivative of esomeprazole, which is the main metabolite, determined in blood plasma. The parameters given below mainly reflect the nature of pharmacokinetics in patients with increased isoenzyme activity CYP2C19.

The total plasma clearance is approximately 17 l / h after a single dose and 9 l / h after repeated administration. The half-life of plasma is 1.3 hours with multiple administration once a day. The pharmacokinetics of esomeprazole was studied with a dose of 40 mg twice daily. Area under the pharmacokinetic curve "concentration-time" (AUC) increased with

repeated administration of esomeprazole. Dose-dependent increase AUC with repeated administration of esomeprazole is nonlinear. Such a time and dose dependence is a consequence of a decrease in the metabolism of esomeprazole on the first pass, and a consequence of a decrease in systemic clearance, probably related to that. what esomeprazole and / or its sulfonic metabolite inhibit the isoenzyme CYP2C19. With daily intake 1 time per day esomeprazole is completely eliminated from the blood plasma during the interval between doses, and does not accumulate.

The main metabolites of esomeprazole do not affect the secretion of gastric acid.When administered orally to 80% of the dose of the drug is excreted as metabolites by the kidneys, the rest is output through the intestine. In urine, less than 1% of unchanged esomeprazole is found.

Peculiarities of pharmacokinetics in some groups of patients.

In elderly patients (71-80 years old), the metabolism of esomeprazole does not undergo

significant change.

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 mild and moderate hepatic insufficiency, the metabolism of esomeprazole 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 metabolites, 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 (t_max) in blood plasma was similar to the values AUC and t_max in adults.

Indications:

reflux disease (GERD):

- treatment of erosive reflux esophagitis;

- prolonged maintenance treatment after healing of erosive reflux esophagitis to prevent relapse;

- symptomatic treatment of GERD.

Stomach ulcer and duodenal ulcer.

In the 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 lowered the secretion of the glands of the stomach, for prophylaxis relapse).

Patients taking long-term NSAIDs:

treatment of gastric ulcer caused by the intake of NSAIDs;

prevention of gastric and duodenal ulcers 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:

- Hypersensitivity to esomeprazole, substituted benzimidazoles or other ingredients that make up the drug.

- Hereditary intolerance to fructose, glucose - galactose malabsorption or sugarazo - isomaltase deficiency.

- 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) and children over 12 years of age on other indications other than GERD.

- Joint reception with atazanavir and nelfinavir (see section "Interaction with other drugs").

- The period of breastfeeding.

Carefully:

with severe renal failure (experience of use is limited), during pregnancy.

Pregnancy and lactation:

At present, there is not enough evidence on the use of esomeprazole during pregnancy. Data on the use of the racemic mixture of omeprazole, obtained during epidemiological studies, indicate the absence of a teratogenic or fetotoxic effect. Animal studies do not indicate a direct or indirect adverse effect of esomeprazole on the development of an embryo or fetus, as well as on the course of labor or postnatal development.

Prescribe the drug to pregnant women only if the expected benefit to the mother exceeds the possible risk to the fetus.

It is not known whether esomeprazole with breast milk. Therefore, appoint esomeprazole during feeding, the pile is not recommended.

Dosing and Administration:

Assigned inside. The tablet should be swallowed whole, washed down with liquid. Tablets can not be chewed or crushed.

For patients with difficulty swallowing, you can dissolve tablets in half a glass of still water (do not use other liquids, since the protective shell of microgranules can dissolve), stirring until the tablet dissolves, and then the slurry should be drunk immediately or for 30 minutes, then refill Glass with water half, place the leftovers and drink. Do not chew or grind microgranules.

For patients who can not swallow, the tablets should be dissolved in still water and injected through a nasogastric tube. Instructions for preparation and administration of the drug through the nasogastric tube are given in the section "Administration of the drug through the nasogastric zonend".

Adults and children from the age of 12 Gastroesophageal reflux disease

Treatment of erosive reflux esophagitis: 40 mg of the drug Esomeprazole Zentiva once a day for 4 weeks.

An additional 4-week course of treatment is recommended in cases when after the first course of healing the esophagitis does not come or the symptoms remain. Long-term maintenance treatment after healing of erosive reflux esophagus to prevent relapse: 20 mg of the drug Ezomeprazole Zentiva once a day. Symptomatic treatment of gastroesophageal reflux disease: 20 mg of the drug Esomeprazole Zentiva once a day to patients without esophagitis. If the symptoms do not disappear after 4 weeks of treatment, an additional examination of the patient should be made. After eliminating the symptoms, you can go to the "if necessary" medication regimen, i.e. Take the drug Esomeprazole Zentiva but 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 Zentiva 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All medications are taken twice a day for 1 week;

- prevention of recurrences of peptic ulcers associated with Helicobacter pylori: Esomeprazole Zentiva 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All medications are taken twice a day for 1 week.

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):

Esomeprazole Zentiva 40 mg once a day for 4 weeks after the end of intravenous therapy with drugs that reduce the secretion of the glands of the stomach.

Patients taking long-term NSAIDs:

- Treatment of gastric ulcer associated with NSAID: Esomeprazole Zentiva 20 mg or 40 mg once daily. The duration of treatment is 4-8 weeks.

- prevention of gastric and duodenal ulcers associated with the administration of NSAIDs: Esomeprazole Zentiva 20 mg or 40 mg once a day.

Conditions associated with pathological hypersecretion of the glands of the stomach, including Zollinger-Ellison syndrome and idiopathic hypersecretion: The recommended initial dose of Esomeprazole Zentiva is 40 mg twice daily. In the future, the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is an experience of using the drug in doses of 80 mg twice a day.

Renal insufficiency: dosage adjustment is not required. However, experience with esomeprazole in patients with severe renal insufficiency is limited; Therefore, when prescribing the drug, such patients should be careful (see section "Pharmacokinetics").

Liver failure: with mild and moderate hepatic insufficiency, dose adjustment 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.

Administration of the drug through a nasogastric tube.

When prescribing the drug through a nasogastric tube:

1. Place the tablet in a syringe and fill the syringe with 25 ml of water and approximately

5 ml of air.For some probes, dilution of the preparation in 50 ml of drinking water may be required in order to prevent the probe from clogging the pellets with a tablet.

2. Immediately shake those syringes for about two minutes to dissolve the tablet.

3. Hold the syringe tipped up and make sure that the tip is not clogged.

4. Insert the tip of the syringe into the probe, continuing to hold it pointed upwards.

5. Shake the syringe and flip it down with a tip. Immediately insert 5-10 ml of dissolved drug into the probe. After the injection, return the syringe to its previous position and shake it (the syringe should be held up by the tip to avoid clogging the tip),

6. Turn the syringe tip down and insert another 5-10 ml of the drug into the probe. Repeat this operation until the syringe is empty.

7. In case of the remainder of the drug in the form of a sludge in the syringe, fill the syringe with 25 ml of water and 5 ml of air and repeat the operations described in clauses 5 and 6. For some probes, 50 ml of drinking water may be needed for this purpose.

Side effects:

The frequency of adverse reactions was determined according to the following gradation (classification of the World Health Organization):

- very frequent - more than 1/10,

- frequent - from more than 1/100 to less than 1/10.

- infrequent - from more than 1/1000 to less than 1/100,

- rare - from more than 1/10000 to less than 1/1000,

- very rare - from less than 1/10000. including individual messages.

Disturbances from the blood system and lymphatic system: very rare - agranulocytosis, pancytopenia; rare - leukopenia, thrombocytopenia.

Immune system disorders: rare - hypersensitivity reactions (fever, angioedema and anaphylactic reaction / shock).

Disorders from the metabolism and nutrition: infrequent - peripheral edema; rare - hyponatremia; very rare - hypomagnesemia (severe hypomagnesemia can correlate with hypocalcemia).

Disorders of the psyche: infrequent - insomnia, drowsiness; rare - agitation, confusion, depression; very rare - aggression, hallucinations.

Impaired nervous system: frequent - headache; infrequent - dizziness, paresthesia; rare - a taste disorder.

Disorders from the side of the organ of vision: rare - blurred vision.

Disturbances from the organs of hearing and balance: infrequent - vertigo.

Disturbances from the respiratory system, chest and mediastinal organs: rare - bronchospasm.

Disorders from the gastrointestinal tract: frequent - abdominal pain, constipation, diarrhea, bloating, nausea, vomiting; infrequent - dry mouth: rare - stomatitis, candidiasis of the gastrointestinal tract; frequency is unknown - microscopic colitis. Disorders from the liver and bile ducts: infrequent - increased activity of "liver" enzymes; rare - hepatitis (with jaundice or without it); very rare - liver failure, encephalopathy in patients with liver disease.

Disturbances from the skin and subcutaneous tissues: infrequent - dermatitis, itching, rash, urticaria; rare - alopecia, photosensitivity; very rare - polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN). Disturbances from the musculoskeletal and connective tissue: infrequently - fractures of the neck of the hip, bones of the wrist, vertebrae; rare - arthralgia, myalgia; very rare - muscle weakness.

Disorders from the kidneys and urinary system: very rare - interstitial nephritis, kidney failure.

Violations of the genitals and mammary glands: very rare - gynecomastia. General disorders and complications at the site of administration: rare - malaise, increased sweating.

Overdose:

At the moment, very rare cases of deliberate overdose are described. The intake of esomeprazole inside 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. The antidote of esomeprazole is unknown. The drug binds well to plasma proteins, so dialysis is ineffective. In case of an overdose, it is necessary to carry out symptomatic and general supportive treatment.

Interaction:

Drugs with pH-dependent absorption

A decrease in intragastric acidity during treatment with esomeprazole may increase or decrease absorption of drugs if the absorption mechanism depends on the acidity in the stomach.

Esomeprazole, like antacids and other drugs that reduce the secretion of hydrochloric acid in the stomach, can lead to a decrease in the absorption of ketoconazole and itraconazole. Digoxin absorption may increase during treatment with esomeprazole. The concomitant treatment with omeprazole (20 mg per day) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two of the ten subjects). The toxic effect of digoxin was rare.However, caution should be exercised when using esomeprazole in high doses in elderly patients. Therefore, monitoring of digoxin content in blood should be strengthened.

It was shown that omeprazole interacts with some antiretroviral drugs. The mechanisms and the clinical significance of these interactions are not always known. An increase in pH on the background of omeprazole therapy may affect the absorption of antiretroviral drugs. It is also possible to interact at the isoenzyme level CYP2C19. When co-prescribing omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, against the background of therapy with omeprazole. there is a decrease in their concentration in the serum. The simultaneous administration of omeprazole (40 mg once daily) with atazanavir 300 mg / ritonavir 100 mg to healthy volunteers resulted in a significant decrease in the bioavailability of atazanavir (the area under the concentration-time curve, the maximum (C_max) and minimal (C_min) concentrations decreased by approximately 75%). An increase in the dose of atazanavir to 400 mg did not compensate for the effects of omeprazole on the bioavailability of atazanavir.

With the simultaneous administration of omeprazole and saquinavir, an increase in the concentration of saquinavir in serum was noted. When administered 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.

When using esomeprazole in combination with drugs involved in the metabolism of isoenzyme CYP2C19. such as diazepam, citalopram, imipramine, clomipramine, phenytoin , etc., plasma concentrations of these drugs may increase, which may require a dose reduction. This should especially be taken into account when prescribing esomeprazole for treatment in the "if necessary" mode. Simultaneous use of 30 mg of esomeprazole leads to a decrease in the clearance of diazepam by 45%, which is the substrate of the isoenzyme CYP2C19. Simultaneous use of 40 mg of esomeprazole leads to an increase in the residual concentration of phenytoin in the blood plasma in patients with epilepsy by 13%.In this regard, it is recommended to monitor the concentration of phenytoin in the blood plasma at the beginning of treatment with esomeprazole and when it is withdrawn.

The simultaneous administration of warfarin with 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 - 32% and half-life at 31%, but the maximum concentration of cisapride in blood plasma, however, does not change significantly. Slight lengthening of the interval QT, which was observed with monotherapy with cisapride, did not increase with addition of esomeprazole (see section "Special instructions").

Effect of drugs on the pharmacokinetics of esomeprazole.

In the metabolism of esomeprazole, isozymes participate CYP2C19 and CYP3A4. Its combined use with clarithromycin (500 mg twice a day), which inhibits isoenzyme CYP3A4, leads to an increase in the value AUC esomeprazole 2 times. Joint use of esomeprazole and a combined inhibitor of isoenzymes CYP3A4 and CYP2C19, for example, voriconazole, can lead to more than 2-fold increase in the value AUC esomeprazole. As a rule, in such cases, dose adjustment is not required. Correction of the dose may be required in patients with severe impairment of liver function and with prolonged therapy.

Drugs that induce isoenzymes CYP2C19 or CYP3A4. or both enzymes (such as rifampicin and St. John's wort), can lead to a decrease in the concentration of esomeprazole in the blood serum due to a more intensive metabolism of the drug.

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 taking esomeprazole Zentiva "but necessary" should be instructed to contact their physician if the symptoms change. Taking into account the fluctuations in the plasma esomeprazole concentration when administering therapy "as necessary", it is necessary to take into account the interaction of the drug with other drugs (see the section "Interaction with other drugs") .In the appointment of esomeprazole for eradication Helicobacter pylori the possibility of drug interactions for all components of therapy should be taken into account. Clarithromycin is a potent inhibitor of isoenzyme CYP3A4,therefore, in the appointment of eradication therapy to patients receiving other drugs metabolized with the participation of isoenzyme CYP3A4 (eg, cisapride), it is necessary to take into account possible contraindications and interactions of clarithromycin with these drugs.

Tablets Esomeprazole Zentiva contain sucrose, so they are contraindicated in patients with hereditary intolerance to fructose,Glucose-galactose malabsorption or sugar-isomaltase deficiency.

Treatment with proton pump inhibitors can lead to a slight increase in the risk of gastrointestinal infections, such as Salmonella and Campylobacter. Influence on the indicators of laboratory studies.

Esomeprazole is able to cause an increase in the level of chromogranin A, which can distort the results of examinations in neuroendocrine tumors. To avoid these problems, treatment with esomeprazole should be temporarily suspended, at least five days before the determination of chromogranin A.

Esomeprazole, like all drugs that reduce acidity, can lead to reduced absorption of the vitamin B12(cyanocobalamin) in connection with hypo- or chlorhydria. This should be considered in patients with risk factors for reducing absorption of vitamin B12 with long-term therapy.

When using proton pump inhibitors, especially when used in large doses and for an extended period (> 1 year), there may be a risk of fracture of the femoral neck, wrist and vertebrae (especially in elderly patients).

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

Due to the fact that during therapy with esomeprazole Zentiva may experience dizziness, blurred vision and drowsiness, use caution when driving and other mechanisms.

Form release / dosage:

Tablets are enteric-soluble 20 mg, 40 mg.

Packaging:For 5, 7 or 10 tablets in a blister of PVC / aluminum foil. 3 blisters of 5 tablets, 1, 2 or 4 blister but 7 tablets, 3, 5, 6 or 9 blisters 10 tablets together with instructions for use in paper cartons.

Storage conditions:

Store in a dry 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 stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003136

Date of registration:10.08.2015

Date of cancellation:2018-05-07

The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic

Manufacturer: & nbsp

ZENTIVA, k.s. Czech Republic

Representation: & nbspZENTIVA ZENTIVA Czech Republic

Information update date: & nbsp07.05.2018

Illustrated instructions

Instructions

Esomeprazole Zentiva (Ezomeprazol Zentiva)