Ortanol, 40 mg 14 pcs.

Reflux esophagitis, Pain in the epigastric region, Heartburn, Gastric and duodenal ulcer, Sour belching, Nausea, GI infections caused by Helicobacter pylori

Symptoms of gastroesophageal reflux, such as heartburn, sour belching.

Active ingredient

Omeprazole

Composition

1 capsule contains:

Active substance:

omeprazole 40 mg;

Associates:

Hyprolose low substituted;

MCC;

anhydrous lactose;

sodium croscarmellose;

p> povidone;

polysorbate 80;

hypromellose phthalate;

dibutylsebakat;

talc;

Capsule shell:

Hypromellose; carrageenan; potassium chloride; titanium dioxide; iron (III) oxide yellow; iron (III) oxide red; water; ink for the inscription (ferric (III) oxide black (E172), shellac, anhydrous ethanol, anhydrous isopropanol, propylene glycol, butanol, ammonium hydroxide, potassium hydroxide, purified water).

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How to take, the dosage

Ingestion, before meals.

The initial dose is 20 mg (2 capsules) once daily. When symptoms begin to disappear, the dose may be reduced to 10 mg daily and increased again to 20 mg once daily if symptoms reappear. It may be necessary to take the drug for 3 to 4 days to achieve relief of symptoms.

The maximum daily dose of the drug should not exceed 20 mg.

The lowest effective dose should always be used. The maximum course of treatment is 14 days. The interval between 14-day courses of treatment without consulting a physician should be at least 4 months.

If within 2 weeks there is no relief of symptoms or they worsen, you should see your doctor.

The capsule should be swallowed whole with plenty of fluid. If the patient is unable to swallow the Ortanol® capsule whole, the contents may be dissolved in a small amount of water or fruit juice (do not dissolve in carbonated beverages). The resulting solution of the drug should be drunk immediately after preparation with an additional 1/2 cup of water.

Patients with impaired renal function:Dose adjustment is not required.

Patients with impaired liver function:Consult a physician before use.

Elderly patients:Although the metabolic rate of omeprazole is reduced in elderly persons, no dose adjustment is required when using the drug at a daily dose of 20 mg or less.

Interaction

A physician should be consulted before taking Ortanol® when treating one or more of the drugs listed in this section.

Concomitant use with omeprazole may result in increased or decreased absorption of drugs whose bioavailability is largely determined by gastric acidity (including erlotinib, ketoconazole, itraconazole, iron preparations and cyanocobalamin).

Concomitant use with omeprazole may significantly decrease the plasma concentration of atazanavir. Simultaneous use is possible only if prescribed by a physician (dosage and regimen of atazanavir are corrected if necessary).

The bioavailability of digoxin in concomitant use with omeprazole increases by 10% (dosing regimen of digoxin may need to be adjusted). Caution should be exercised when concomitant use of these drugs in elderly patients.

In concomitant use of omeprazole with clopidogrel a decrease in the antiaggregant effect of the latter is observed.

The concomitant use of Omeprazole increases the plasma concentration of tacrolimus, which may require dose adjustment.

Concomitant use of omeprazole increases plasma concentrations of saquinavir/ritonavir up to 70%, and tolerability in patients with HIV infection is not impaired.

Simultaneous use with CYP2C19 and CYP3A4 isoenzyme inhibitors (such as clarithromycin, voriconazole) may lead to increased plasma concentrations of omeprazole, which may require adjustment of the omeprazole dose in patients with severe hepatic impairment if used long-term.

The inducers of CYP2C19 and CYP3A4 isoenzymes (e.g., rifampicin, preparations of Hypericum perforatum) may increase metabolism of omeprazole, thereby reducing its plasma concentration.

No clinically significant interaction of omeprazole with antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, metoprolol, ethanol has been established.

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Special Instructions

Omeprazole is not indicated for occasional heartburn (heartburn less than 2 times a week).

Before starting therapy with omeprazole, it is important to rule out the presence of a malignancy, because treatment, by masking symptoms, can delay a correct diagnosis.

Omeprazole will decrease gastric acidity, which may slightly increase the risk of digestive tract infections.

Influence on the ability to drive vehicles and perform other activities requiring concentration and quick psychomotor reactions

Influence on the ability to drive and perform other activities requiring concentration and quick psychomotor reactions. During treatment with omeprazole dizziness, somnolence, visual disturbances may occur, and therefore caution should be exercised when driving motor vehicles and performing other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Special precautions for disposal of unused drug. Not required.

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Contraindications

• high sensitivity to omeprazole or other drug components
• age under 18 years
• concomitant use with nelfinavir;
• hereditary forms of galactose intolerance, lactase deficiency or glucose/galactose absorption disorders (because they contain lactose).

Cautions:Consider the following before using:

• presence of previously diagnosed peptic ulcer disease, severe liver disease accompanied by liver failure, jaundice, previous GI surgery;
• presence of alarming symptoms: significant weight loss, recurrent vomiting, vomiting blood (hematemesis), impaired swallowing, change in stool color (tarry stool – melena);
• appearance of new symptoms or change in existing GI symptoms; having symptomatic treatment for digestive disorders or heartburn for 4 weeks or more; concurrent use with one or more of the following drugs atazanavir, clopidogrel, digoxin, erlotinib, ketoconazole, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, St John’s wort preparations.

You should also consult your physician before using Ortanol® during pregnancy and lactation.

The drug should not be used for prophylactic purposes.

Side effects

Allergic reactions: infrequent – urticaria, skin rash, itching; rare – fever, angioedema, anaphylactoid reactions; very rare – eosinophilia.

Gastrointestinal disorders: frequently – nausea, vomiting, abdominal pain, diarrhea or constipation, flatulence; infrequently – increased transaminase and ALP activity; rarely – dry mouth, stomatitis, gastrointestinal candidiasis, hepatitis (with or without jaundice); very rarely – liver failure (in patients with previous severe liver disease).

Nervous system: frequently – headache; infrequently – dizziness, paresthesia, somnolence, insomnia; rarely – agitation, reversible confusion, depression, violation of taste; very rarely – aggression, hallucinations; against severe liver disease – encephalopathy.

Skin disorders: infrequent dermatitis, photosensitization, alopecia, very rare erythema multiforme, Stevens-Johnson syndrome (severe erythema multiforme characterized by spots and blisters on the skin and mucous membranes with fever and pain in the joints), toxic epidermal necrolysis.

Sensory organs: rarely – visual impairment.

Musculoskeletal system: rarely – myalgia, arthralgia, very rarely – muscle weakness.

Respiratory system: rare – bronchospasm.

The urinary system: rarely – interstitial nephritis.

Hematopoietic organs: rare – leukopenia, thrombocytopenia; very rare – agranulocytosis, pancytopenia.

Others: infrequent peripheral edema; rare – increased sweating, hyponatremia; very rare – hypomagnesemia, gynecomastia.

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Overdose

Symptoms: dry mouth, nausea, vomiting, increased sweating, headache, drowsiness, confusion, visual disturbances, tachycardia.

Treatment: symptomatic. There is no specific antidote. Hemodialysis is ineffective.

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Similarities

Omez, Omisak, Gastrozol, Losek MAPS, Ultop, Ortanol, Omitox, Omeprazol, Omeprazol-Teva