Ortanol - instructions for use, dose, side effects, contraindications

Excipients: giprolose low-substituted 20.0 mg / 20.0 mg, microcrystalline cellulose 14.0 mg / 14.0 mg, anhydrous anhydrous 117,0 mg / 112.0 mg, croscarmellose sodium 20.0 mg / 20.0 mg, povidone 8,0 mg / 8.0 mg, polysorbate 80 1.0 mg / 1.0 mg, hypromellose phthalate 48,612 mg / 48,612 mg, dibutyl sebacate 0,893 mg / 0,893 mg, talc 0,495 mg / 0,495 mg;

Capsule shell: hypromellose 54.8025 mg / 63.8600 mg, carrageenan 0.2160 mg / 0.2500 mg, potassium chloride 0.3600 mg / 0.4200 mg, titanium dioxide 1.6215 mg / 1.8957 mg, iron (III) oxide yellow - / 0.0453 mg, iron (III) oxide red - / 0.029 mg, water 3.0000 mg / 3.5000 mg;

Inks for inscription (E 172) 24-28%, shellac 24-27%, ethanol anhydrous 23-26%, isopropanol anhydrous 1-3%, propylene glycol 3-7%, butanol 1- 3%, ammonium hydroxide 1-2%, potassium hydroxide 0.05-0.1%, purified water 15-18%).

Description:

Capsules 20 mg: solid capsule number 2, body and cover white, on both sides of the capsule inscription OME 20 black.

Capsules 40 mg: hard capsule number 1, white cap, body of light pinkish-brown color, on both sides of the capsule inscription OME 40 black.

For both dosages: the contents of the capsule are light-yellow granules.

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

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:Mechanism of action

Omeprazole is a racemic mixture of two enantiomers, reduces the secretion of gastric juice through a highly selective mechanism of action. Omeprazole is a weak base, accumulates in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, is activated and inhibits the enzyme H⁺, K-ATPase. Effect of omeprazole on the last stage of the formation of hydrochloric acid in the stomach is dose-dependent and provides a highly effective inhibition of basal and stimulated secretion of hydrochloric acid regardless of the stimulating factor. After a single dose of the drug inside the action of omeprazole occurs within the first hour and lasts for 24 hours. The maximum effect is achieved after 2 hours. After discontinuation of the drug, the secretory activity is completely restored after 3-5 days.

Effect on the secretion of hydrochloric acid in the stomach

When omeprazole is administered once a day, rapid and effective inhibition of day and night secretion of gastric juice is provided. The maximum effect is achieved within 3-5 days of treatment. In patients with duodenal ulcer, the administration of 20 mg of omeprazole causes an average of 80% reduction in 24-hour gastric acidity. The average decrease in the maximum acid secretion after stimulation with pentagastrin is about 70% after 24 hours. In oral administration of 20 mg of omeprazole, patients with peptic ulcer of the duodenum maintain an intragastric pH of> 3 on average for 17 hours per day.

Inhibition of acid secretion depends on the area under the concentration-time curve (AUC) omeprazole, and not from the plasma concentration of omeprazole at a given time.

Action on Helicobacter pylori

Omeprazole has a bactericidal effect on N. pylori in vitro. Eradication N. pylori when omeprazole is used together with antibacterial drugs it is accompanied by a rapid elimination of symptoms, a high degree of healing of defects in the gastrointestinal mucosa (GI tract) and a prolonged remission of peptic ulcer, which reduces the likelihood of complications such as bleeding,as effectively as constant maintenance therapy.

Other effects associated with inhibition of acid secretion

There are reports of a slight increase in the incidence of glandular cysts in the stomach in patients with prolonged treatment. Similar changes are the physiological consequences of pronounced inhibition of acid secretion, they are benign and reversible with continued therapy.

The decrease in acid secretion in the stomach by proton pump inhibitors or other acid-inhibiting agents can lead to a slight increase in the risk of intestinal infections caused by pathogens such as Salmonella spp., Campylobacter spp., and also, probably, Clostridium difficile.

During the use of drugs that reduce the secretion of the glands of the stomach, the concentration of gastrin in the serum increases. Due to a decrease in the concentration of hydrochloric acid, the concentration of chromogranin A (CgA) in blood plasma, which can lead to false-positive results in the diagnosis of patients with suspected neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be stopped at least 5-14 days before the study concentration CgA. If during this time the concentration did not return to the normal value, the study should be repeated.

In children and adults who use for a long time omeprazole, there was an increase in the number of enterochromaffin-like cells, probably due to an increase in the concentration of gastrin in the blood serum. Clinical significance of this phenomenon is not.

Pharmacokinetics:

Omeprazole is rapidly absorbed from the digestive tract, the maximum concentration in the blood plasma is reached after 1-2 hours. antisecretory effect occurs within the first hour, reaching a maximum 2 hours after oral administration. Absorption of omeprazole occurs in the small intestine and is completely completed within 3-6 hours. Inhibition of 50% of maximum secretion continues for 24 hours.

Bioavailability when taking a single dose is 30-40% and increases with repeated admission to 60%. The connection with blood plasma proteins is about 97%. The volume of distribution is 0.3 l / kg.

Omeprazole is almost completely is metabolized in the liver with the help of cytochrome P450 isoenzymes (RMS) with the formation of 6 pharmacologically inactive enzymes. The main pathway of metabolism is through isoenzyme CYP2C19. Another way - with the participation of cytochrome isoenzyme CYP3A4. The result of the high affinity of omeprazole to the isoenzyme CYP2C19 is the possibility of competitive inhibition and metabolic interactions with other isoenzyme substrates CYP2C19. However, due to the low affinity to the isoenzyme CYP3A4 omeprazole does not inhibit the metabolism of other isoenzyme substrates CYP3A4. Omeprazole has no inhibitory effect on the main isoenzymes of the cytochrome system CYP.

Approximately 3% of Caucasians and 15-20% of Asians reduced isoenzyme activity CYP2C19, those. they are "slow" metabolizers. In these individuals, the metabolism of omeprazole, in all probability, occurs primarily through isoenzyme CYP3A4. With the repeated use of 20 mg of omeprazole once a day, the mean AUC was 5-10 times higher in "slow" metabolizers, compared with individuals with normal isoenzyme activity CYP2C19. The mean peak plasma concentrations were also 3-5 times higher. These data have no effect on the dosage regimen of omeprazole.

Excretion

The total plasma clearance is 0.3-0.6 l / min.

The half-life is 0.5-1 hour. It is excreted as metabolites by the kidneys (70-80%) and with bile (20-30%).

In patients with impaired liver function increased bioavailability of omeprazole and a significant decrease in plasma clearance.

In patients with impaired renal function There were no significant changes in the pharmacokinetics of omeprazole. In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.

In elderly patients (older than 75 years) slightly decreases the metabolic rate of omeprazole.

Indications:

- Stomach ulcer and duodenal ulcer (including prevention of relapses);

- eradication Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (as part of combination therapy);

- reflux-esophagitis (including maintenance therapy of reflux-esophagitis in the phase of remission and symptomatic treatment of gastro-esophageal reflux);

- hypersecretory conditions (Zollinger-Ellison syndrome, polyendocrine adenomatosis, systemic mastocytosis, stress ulcers of the gastrointestinal tract);

- prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of non-steroidal anti-inflammatory drugs (dyspepsia, erosion of the mucous membrane, peptic ulcer);

- dyspepsia associated with increased acidity.

Contraindications:

- Hypersensitivity to omeprazole or other components of the drug;

- rare hereditary forms of lactose intolerance, deficiency of lactase, sucrose / isomaltase or impaired absorption of glucose / galactose (because the composition contains lactose);

- simultaneous use with nelfinavir, erlotinib and posaconazole;

- Children under 2 years of age and with a body weight of less than 20 kg (with the treatment of reflux-esophagitis, symptomatic treatment of heartburn and eructations with acidic in gastroesophageal reflux disease);

- Children under 4 years of age (or with a body weight of less than 31 kg) (in the treatment of duodenal ulcers caused by Helicobacter pylori).

Carefully:

- Severe hepatic impairment;

- kidney failure;

- the presence of "anxious" symptoms: unintentional significant weight loss, repeated vomiting, vomiting with a trace of blood (hematemesis), swallowing disorders, discoloration of stool (tarry stool - melena);

- risk of vitamin B deficiency12 (cyanocobalamin);

- Osteoporosis;

- simultaneous use with atazanavir (see. section "Special instructions"), clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, St. John's wort preparations (see p. section "Interaction with other drugs"");

- Pregnancy.

Pregnancy and lactation:

Pregnancy

The results of three prospective epidemiological studies (more than 1000 observations) showed that the use of omeprazole in pregnant women does not adversely affect the course of pregnancy and fetus / newborn health. Ortanol® can be used during pregnancy.

Breast-feeding

Omeprazole penetrates into breast milk, but when applied in therapeutic doses, exposure to the baby is unlikely. Ortanol® can be used in the period breastfeeding.

Fertility

Studies in animals with by oral administration racemic mixture of omeprazole is not revealed the effects of the drug on fertility.

Dosing and Administration:

Application the of adults

Inside, preferably before meals (usually in the morning before breakfast).

The capsule should be swallowed whole, with enough liquid. If the patient can not swallow the capsule of Ortanol® whole, you can dissolve the contents in a small amount of water, fruit juice (for example,apple or orange) or yogurt and use the resulting suspension for 30 minutes. Do not use the drug with milk or soda water. If you missed taking the drug, you must take the drug immediately, as soon as you remember. If it is time to take the next dose of Ortanol®, take it without doubling.

Peptic ulcer disease of the duodenum

Recommended The dose for treatment of patients with duodenal ulcer during the exacerbation is 20 mg once a day for 2 weeks. In the event that after the first course of the drug is not fully healing of the ulcer, a second two-week course of therapy is prescribed. For patients with insufficient response to treatment, Ortanol® capsules 40 mg once a day are prescribed. In this case, ulceration usually occurs within four weeks.

To prevent recurrence of patients with duodenal ulcer recommend the drug Ortanol® 20 mg once a day. If necessary, the dose can be increased to 40 mg once a day.

Stomach ulcer

Recommended dose for the treatment of patients with gastric ulcer in the acute stage is 20 mg 1 time perday for 4 weeks. In the event that after the first course of application of the drug there is no complete healing, appoint a second four-week course of therapy. With gastric ulcer resistant to therapy, use the drug Ortanol capsules 40 mg once a day. In this case, healing usually occurs within eight weeks.

To prevent recurrence of patients with peptic ulcer disease recommend the drug Ortanol ® 20 mg once a day, if necessary, it is possible to increase it to 40 mg once a day.

Eradication Helicobacter pylori in combination therapy

Preparation Ortanol capsules 20 mg twice daily before meals for 1 -2 weeks in combination with antibacterial drugs. When choosing an antibiotic, one should be guided by the patient's individual sensitivity and national, regional and local recommendations. The following combinations are most often used three-component scheme treatment:

- omeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg twice a day, morning and evening;

- omeprazole 20 mg + metronidazole 400 mg (or 500 mg) + clarithromycin 250 mg (or 500 mg) twice a day, morning and evening;

- omeprazole 20 mg + tinidazole 500 mg + clarithromycin 500 mg twice a day, morning and evening;

- omeprazole 20 mg + amoxicillin 1000 mg + levofloxacin 500 mg twice a day, morning and evening.

It is also possible to use the following combinations four-component treatment regimens:

- omeprazole 20 mg twice a day + metronidazole 400 (or 500) mg twice daily + tetracycline 500 mg 4 times a day + bismuth tricalcium dicitrate 120 mg 4 times a day;

- omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1000 mg + metronidazole 500 mg twice a day, morning and evening.

It is also effective to use a sequential therapy regimen:

- 5 days - omeprazole 20 mg + amoxicillin 1000 mg twice a day;

- then 5 days - omeprazole 20 mg + clarithromycin 500 mg 2 times a day + tinidazole 500 mg twice a day.

In those cases when, after taking a course of treatment, a test for Helicobacter pylori remains positive, the course of treatment can be repeated.

Treatment of reflux esophagitis

Ortanol capsules are prescribed 20 mg once a day for 4 weeks. In the event that after the first course of the drug is not fully cured, a four-week course of therapy is prescribed. In severe forms of reflux esophagitis, the dose can be increased to 40 mg per day, recovery usually occurs within 8 weeks.

Supportive treatment of patients with reflux-esophagitis in remission

The recommended dose for prolonged maintenance treatment of patients with reflux-esophagitis in remission is 20 mg per day. If necessary, it is possible to increase the dose of Ortanol® to 40 mg once a day.

Symptomatic gastroesophageal reflux disease

The dosage regimen is set individually. The drug is used for 20 mg / day. The course of treatment (Ortanol® 20 mg once a day) is 4 weeks. If the symptoms do not disappear after the therapy, an additional examination of the patient is recommended.

For pain, heartburn, or discomfort in the epigastric region associated with acid-dependent dyspepsia the dosage regimen is set individually. The drug is prescribed at 20 mg / day. The course of treatment is 4 weeks. If the symptoms do not disappear after 4 weeks of Ortanol® 20 mg per day, an additional examination of the patient is recommended.

Hyper-secretory conditions

The dose of Ortanol® and the duration of treatment for patients with Zollinger-Ellison syndrome are selected individually.

The recommended initial dose for adults is 60 mg once a day, the maximum - 120 mg per day.When appointing a dose exceeding 80 mg / day, it is divided into several receptions.

Prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs)

Prophylaxis - 1 capsule of Ortanol® 20 mg daily before breakfast during the whole course of treatment with NSAIDs.

Treatment - 20 mg per day for 4-8 weeks.

Application the children

Treatment of reflux esophagitis

Symptomatic treatment of heartburn and eructations with acidic gastroesophageal reflux disease

In children older than 2 years and with a body weight of more than 20 kg, the use of Ortanol capsules 20 mg is recommended once a day. If necessary, the dose can be increased to 40 mg once a day.

The duration of treatment is 4-8 weeks.

Symptomatic treatment of heartburn and eructations with acidic gastroesophageal reflux disease

The duration of treatment is 2-4 weeks. If omeprazole is used for 2-4 weeks, the symptoms do not disappear, further examination is recommended.

Children older than 4 years (or weighing more than 31 kg) and adolescents

Treatment of duodenal ulcers caused by Helicobacter pylori

When choosing an antibiotic for the appropriate combination therapy, individual patient tolerability of the drugs must be considered. Drugs should be administered in accordance with the nature of the resistance and the treatment guidelines adopted in the country in question. at the regional level, and also at the local level, taking into account the duration of treatment (usually 7 days, sometimes 14 days) and the appropriate use of antibacterial drugs.

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

The following doses are recommended:

Body mass	Dose
31-40 kg	Combination with two antibiotics: 20 mg of omeprazole, 750 mg of amoxicillin and clarithromycin 7.5 mg / kg body weight simultaneously twice a day for one week
> 40 kg	Combination with two antibiotics: 20 mg omeprazole, 1 g amoxicillin and 500 mg clarithromycin simultaneously twice a day for one week

Have patients with impaired liver function the daily dose should not exceed 20 mg.

Have patients with impaired renal function correction of the dose is not required.

Have elderly patients (older than 65 years) dose adjustment is not required.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Violations of the blood and lymphatic system

rarely: leukopenia, thrombocytopenia;

rarely: agranulocytosis, pancytopenia.

Immune system disorders

rarely: hypersensitivity reactions (eg, fever, angioedema, anaphylactoid reactions / anaphylactic shock);

rarely: eosinophilia.

Disorders from the metabolism and nutrition

rarely: hyponatremia;

frequency is unknown: hypomagnesemia (severe hypomagnesemia may lead to hypocalcemia) may be associated with hypokalemia.

Disorders from the digestive system

often: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain;

infrequently: increased activity of "liver" transaminases and alkaline phosphatase;

rarely: dryness of the oral mucosa, stomatitis, candidiasis of the gastrointestinal tract, hepatitis (with jaundice or without), microscopic colitis;

rarely: hepatic failure, hepatic encephalopathy (in patients with a previous severe liver disease).

Disturbances from the nervous system

often: headache;

infrequently: dizziness, paresthesia, drowsiness, insomnia;

rarely: stimulation, confusion, depression, violation of taste sensations;

rarely: aggression, hallucinations.

Disturbances on the part of the organ of sight

rarely: blurred vision.

Hearing disorders and labyrinthine disorders

infrequently: Vertigo.

Disturbances from the skin and subcutaneous tissues

infrequently: urticaria, skin rash, itching, dermatitis;

rarely: photosensitivity, alopecia;

rarely: multiforme exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis;

frequency is unknown: subacute cutaneous lupus erythematosus.

Disturbances from musculoskeletal and connective tissue

infrequently: fracture of the femoral neck, bones of the wrist and spine long-term therapy;

rarely: myalgia, arthralgia;

rarely: muscle weakness.

Disturbances from the respiratory system, chest and mediastinal organs

rarely: bronchospasm.

Disorders from the kidneys and urinary tract

rarely: interstitial nephritis.

Violations of the genitals and mammary gland

rarely: gynecomastia.

Common disorders and disorders together

infrequently: malaise, peripheral edema;

rarely: increased sweating.

There have been reports of the formation of gastric glandular cysts during prolonged treatment with proton pump inhibitors (a consequence of inhibiting the secretion of hydrochloric acid, is benign).

Overdose:

Single use of 560 mg omeprazole by adults caused symptoms of moderate intoxication. A case of application of 2400 mg of omeprazole at a time is described, not causing any severe toxic symptoms. With increasing dose, the elimination rate of the drug did not change (first-order kinetics), but no specific treatment was required.

Symptoms: dryness of the oral mucosa, nausea, vomiting, flatulence, diarrhea, increased sweating, headache, drowsiness, dizziness,confusion, visual impairment, tachycardia.

Treatment: symptomatic. There is no specific antidote. Hemodialysis is ineffective to remove the omeprazole from the body in connection with a high degree of protein binding.

Interaction:

With simultaneous application with omeprazole, there may be an increase or decrease in absorption drugs, bioavailability of which is largely determined by the acidity of the gastric juice (incl. erlotinib, ketoconazole, itraconazole, posaconazole, iron preparations and cyanocobalamin).

Simultaneous application omeprazole with posaconazole and erlotinib it is contraindicated.

With simultaneous application with omeprazole, a significant decrease in plasma concentration atazanavir and nelfinavir. Simultaneous the use of these drugs is not recommended.

When used simultaneously with omeprazole there is an increase in plasma concentration saquinavir / ritonavir up to 70%, while the tolerability of treatment for patients with HIV infection does not deteriorate.

Bioavailability digoxin at simultaneous application with 20 mg of omeprazole is increased by 10%.Care should be taken when applying these drugs in elderly patients.

With simultaneous application with omeprazole, an increase in plasma concentration and an increase in the half-life warfarin (R-warfarin) or other antagonists of vitamin K, cilostazol, diazepam, phenytoin, as well as other drugs metabolized in the liver by isoenzyme CYP2C19 (a reduction in the doses of these drugs may be required). but concomitant therapy with omeprazole 20 mg does not affect the concentration of phenytoin in the blood plasma of patients taking the drug for a long time. When using omeprazole patients receiving warfarin or other antagonists of vitamin K, it is necessary to monitor International Normalized Relationship (INR). In some cases, you may need a reduced dose of warfarin or other antagonist of vitamin K. However, co-treatment with omeprazole in a daily dose of 20 mg leads to a change of coagulation time in patients receiving long-term warfarin. The use of omeprazole at a dose of 40 mg once a day led to an increase in the maximum plasma concentration and AUC of cystostaxol by 18% and 26% respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.

Simultaneous application The use of clopidogrel and omeprazole should be avoided (alternative routes antiaggregant therapy). when combined, plasma concentration decreases Clopidogrel by 46% on the first day and 42% on the fifth day of use, and the maximum inhibition of ADP-induced aggregation

thrombocytes on average by 16%. In this case, the use of drugs at different times of the day does not exclude the possibility of their interaction. Omeprazole with simultaneous application increases the plasma concentration tacrolimus, which may require dose adjustment. During the period of combined treatment, the concentration of tacrolimus in the blood plasma and the kidney function (creatinine clearance) should be carefully monitored.

Some patients reported increased plasma concentrations of methotrexate against the background of simultaneous use with proton pump inhibitors. When using high doses of methotrexate, the possibility of temporary discontinuation of the drug should be considered.

Simultaneous application with inhibitors of isoenzymes CYP2C19 and CYP3A4 (such as clarithromycin, voriconazole) can lead to an increase in the plasma concentration of omeprazole more than double, which may require correction of the dose of omeprazole in patients with severe hepatic insufficiency in the case of its long-term use. However, due to the good tolerability of high doses of omeprazole, with a short simultaneous use of these drugs, no dose adjustment is required. Inductors of isoenzymes CYP2C19 and CYP3A4 (eg, rifampicin, preparations of St. John's wort perfumed (Hypericum perforatum)) with simultaneous application with omeprazole can increase its metabolism, thereby reducing its concentration in the plasma.

No clinically significant interaction of omeprazole with antacids, theophylline, caffeine, S-warfarin, piroxicam, diclofenac, naproxen, quinidine, lidocaine, propranolol, metoprolol, ethanol.

Special instructions:

In the presence of any "alarming" symptoms (unintended significant weight loss without obvious cause and / or lack of appetite,repeated vomiting, vomiting with an admixture of blood (hematemesis), violation of swallowing, discoloration of stool (tarry stool - melena)), as well as with suspected or confirmed gastric ulcer before the start of therapy, it is necessary to exclude the presence of malignant process, t. treatment, masking the symptoms, can delay the setting of the correct diagnosis.

The diagnosis of reflux esophagitis should be confirmed with a gastroscopy.

Patients over the age of 45 with symptoms of heartburn, suffering from heartburn for the first time, can take Ortanol® only after consulting a doctor.

Some children with chronic illness may require long-term treatment with omeprazole, despite the fact that it is not recommended.

Treatment with medicinal drugs that reduce production of hydrochloric acid may increase the risk of developing gastrointestinal infection caused by Salmonella spp. or Campilobacter spp.

It is not recommended to take atazanavir from proton pump inhibitors. If necessary combination therapy atazanavir and inhibitors proton pump should be monitored viral load with a simultaneous increase in dose atazanavir up to 400 mg in combination with ritonavir 100 mg.An increase in the dose of omeprazole over 20 mg is not recommended.

Omeprazole, like all drugs that lower the level of acidity, can lead to reducing the absorption of vitamin B12 (cyanocobalamin). This should be taken into account when using Ortanol in patients with insufficiency or risk development of vitamin B12 deficiency in long-term therapy.

With prolonged use of omeprazole (for three months or more), patients experienced severe hypomagnesemia, the clinical signs of which may be fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia. In most cases, signs of hypomagnesemia occur with magnesium therapy and / or discontinuation of proton pump inhibitors. Therefore, with prolonged therapy of patients with Ortanol®, as well as with simultaneous use with digoxin or drugs that can cause hypomagnesemia (eg, diuretics), it is necessary to monitor the magnesium content in the blood plasma.

With prolonged use (more than 1 year) of omeprazole, there is a risk of fracture of the neck of the hip, wrist and spine, especially in elderly patients, and also in the presence of other known risk factors. Clinical studies have shown that proton pump inhibitors increase overall risk the occurrence of fractures by 10-40%, which may be associated with other risk factors.

Patients with suspicion on osteoporosis it is necessary to provide additional treatment in accordance with the current recommendations for the use of vitamin preparations D and calcium.

In the case of prolonged therapy with proton pump inhibitors, especially for more than one year, a regular examination of the patient is necessary.

During the treatment with Ortanol®, an increase concentration of Chromogranin A, used to diagnose neuroendocrine tumors, therefore it is recommended that omeprazole be canceled at least 5 days before the study.

If the values of the concentrations of Chromogranin A and gastrin are not decrease to reference values after the initial study, repeat the study 14 days after the end of the use of proton pump inhibitors.

The use of proton pump inhibitors is associated with very rare cases of development subacute cutaneous lupus erythematosus (PKKV).If skin lesions occur, especially in open sunlight, in conjunction with arthralgia, the patient should immediately seek medical help and the doctor must consider the decision to cancel omeprazole. PKKV in the treatment of proton pump inhibitors in an anamnesis may increase the risk of developing PKKV with the use of other inhibitors of the proton pump.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions when destroying an unused preparation.

Effect on the ability to drive transp. cf. and fur:During the treatment with Ortanol ®, dizziness, drowsiness, and visual impairment may occur, therefore, care should be taken when driving vehicles and performing other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions. When the above-described undesirable phenomena appear, one should refrain from performing these activities.

Form release / dosage:Capsules 20 mg, 40 mg.

Packaging:

For 7 capsules in a blister of rigid matte aluminum foil / soft matte aluminum foil. For 1.2 or 4 blisters together with instructions for use in cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007825/08

Date of registration:06.10.2008 / 29.03.2012

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp15.06.2018

Illustrated instructions

Instructions

Ortanol® (Ortanol®)