International name: Omeprazole, 

ATC CODE: AO2BCO1.

Capsule size number 1.

Capsules "omeprazole Neo" micro-granules contain enteric coated.

COMPOSITION: Active substance: omeprazole (omeprazole in the form of pellets 8.5%) - 20 mg.

Excipients: starch; lactose; talc; calcium carbonate; titanium dioxide; sucrose; sodium carboxymethylcellulose; sorbitol;

Pharmacological group: proton pump inhibitor.

PHARMACHOLOGIC EFFECT:

Pharmacodynamics: "Omeprazole Neo" is a drug for the treatment of gastric ulcer and duodenal ulcer.

The parietal cells of the gastric mucosa, omeprazole is converted to its active form - sulfonamide that inhibits enzyme system (proton pump) H + / K + -ATPase located on the apical membrane of the secretory cells and thereby blocking the final stage of the formation of hydrochloric acid. Depending on the dose of the drug inhibits both basal (DSA), and stimulated secretion of hydrochloric acid (diet, insulin, pentagastrin).

In view of the sharp increase in gastric juice PH, "Omeprazole Neo" has a gastroprotective action: has a bactericidal effect on Helicobacter pylori. High levels PH neutralization occurs ammonium formed by Helicobacter pylori by hydrolysis and becomes detrimental accumulation (toxic) for the microorganisms themselves. This effect occurs only in the antral part of the stomach, and the fundus of the stomach, where the pH reaches the critical index population Helicobacter pylori contrary, multiply by omeprazole as conditions become favorable for bacteria. The phenomenon of displacement of Helicobacter pylori in the antral part of the stomach fundic portion is an important property of the drug. Under the influence "of omeprazole Neo" in the fundus of the stomach multiply antibiotic-sensitive vegetative forms. Therefore, it creates the best conditions for the therapy of H. pylori.

"Omeprazole Neo" for a day keeps a pH level, which has a positive effect on the healing of gastric ulcer and duodenal ulcer. The treatment has been a rapid improvement (passes pain syndrome and dyspepsia), normal morphological state, accelerating the healing process of peptide ulcer.

Pharmacokinetics of omeprazole is unstable in an acidic environment in the stomach of the capsule is rapidly dissolved and released microgranules are coated with a special coating. When injected into the alkaline environment of the duodenum shell microgranules dissolved, providing a gradual absorption of omeprazole. The rate of absorption is independent of food intake. Maximum plasma concentration is reached after 0.5-2 hours. The bioavailability is 30-40%. Repeated dose bioavailability of the drug is increased to 60-70%. The plasma protein binds 95% of the drug. The half-life of 0.5-1 hours. Omeprazole is almost completely metabolized in the liver to form inactive metabolites that are excreted through the kidneys are allocated (70-80%) and intestine (20-30%).

INDICATIONS:

• Stomach ulcer and duodenal ulcer;

• Stomach ulcer and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs;

• Gastroesophageal reflux; reflux esophagitis (erosive or ulcerative);

• Pathological hypersecretory conditions (Zollinger - Ellison syndrome, multiple endocrine adenomatosis, systemic mastocytosis, stress ulcer);

• Peptide ulcer caused by Helicobacter pylori (in combination with antibacterial agents)

• Destruction (eradication) Helicobacter pylori in the gastric mucosa;

• acid-indigestion;

DOSAGE AND METHOD OF ADMISSION: You are advised to take "Omeprazole Neo" one-off in the morning, before or after a meal. It is unacceptable chewing, crushing, damage the capsule.

In gastric ulcer and duodenal ulcer "Omeprazole Neo" is prescribed in an amount of 20 mg (1 capsule) 1 times a day. If necessary, the dose is increased to 40 mg (2 capsules) 1 time per day. The duration of treatment with the duodenal ulcer is at least 4 weeks, and gastric ulcer 6-8 weeks. Short Course "omeprazole Neo" (1-2 weeks) at a dose of 20 mg is sufficient for treatment of gastritis, relieves hyperacidity and stomach irritation.

The syndrome Zollinger - Ellison individual dosage. The initial dose is 60 mg (3 capsules) disposable, then performance can be increased dose up to 120 mg (6 capsules) distributed in 2 hours. The treatment duration is of 2 to 8 weeks.

When reflux esophagitis administered 20-40 mg (1-2 capsules) for 4-12 weeks.

With Helicobacter pylori infection of 20-40 mg administered one time a day for 2 weeks with amoksatsillinom which take in an amount of 750 mg two times a day for 2 weeks.

In gastric ulcer and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs are prescribed 20 mg 1 time a day during 4-8 weeks.

When non-ulcer dyspepsia is prescribed 20 mg 1-2 times a day for 2-3 weeks.

Patients with impaired liver function "Omeprazole Neo" is prescribed in an amount of 20 mg.

When you miss a dose treatment should be continued for the primary circuit.

Cautions: Before treatment to rule out malignancy in the gastrointestinal tract, especially gastric ulcer, because the method of "Omeprazole Neo" may result in masking the symptoms and complications of diagnosis.

For patients with impaired liver function the daily dose should not exceed 20 mg (increased bioavailability).

For the elderly and patients with impaired renal function does not require adjustment of the treatment regimen.

The drug is not administered to children due to the lack of clinical trials data.

SIDE EFFECTS:

"Omeprazole Neo" is generally well tolerated. Side effects are rare, are mild and are reversible.

From the digestive system: diarrhea or constipation, abdominal pain, nausea, flatulence.

From the nervous system: headache, rarely - sleep disturbance, irritability, drowsiness, paresthesia;

From the musculoskeletal system: myalgia, arthralgia, muscle weakness;

Hematopoietic system: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

Allergic reactions: skin rash, itching, hives.

CONTRAINDICATIONS: Hypersensitivity to the components that make up the drug.

LIMITATION OF USE:

Chronic liver disease; pregnancy; lactation; Children's age (except for Zollinger - Ellison syndrome);

Pregnancy and lactation:

In the absence of clinically confirmed information, the use of "Omeprazole Neo" during pregnancy is allowed under the supervision of a physician only when the intended benefits to the mother outweighs the potential risk of adverse effects on the fetus.

If necessary, receive "omeprazole Neo" in the period of lactation, it is necessary to temporarily stop breastfeeding.

DRUG INTERACTIONS sredstavmi or other interactions, "Omeprazole Neo" reduces the metabolism of those drugs, which oxidation occurs in the liver enzyme cytochrome P450. The plasma concentration of diazepam increases, carbamazepine, phenytoin, warfarin and adjust their dose.

When you receive a "omeprazole Neo" together with warfarin is recommended regular monitoring of anticoagulant concentration in serum or control of prothrombin.

"Omeprazole Neo" reinforces the effect of coumarin and difenina. Because lowering gastric acidity decreases the bioavailability of the drugs whose absorption is pH dependent (ketoconazole, iron salts). At simultaneous reception "omeprazole Neo" and clarithromycin increases their concentration in plasma. During the period of treatment is recommended to refrain from smoking and drinking alcohol.

OVERDOSE:

Symptoms: drowsiness, headaches, dizziness, dry mouth, nausea, tachycardia, abdominal pain, fever.

Treatment: symptomatic, there are no specific antidote, activated charcoal or other absorbent material.

Impact on the ability of driving motor transport and mechanisms: In therapeutic doses, the drug has no effect on the ability to concentrate. However, caution should be exercised for patients who have manifested individually drowsiness or weakness and their work requires concentration and quick psychomotor reactions.

SHELF LIFE: 2 years.

After the expiration date of the drug or defects by visual inspection, not allowed to use the drug.

STORAGE: Store at 15-25 ° C, dry, protected from light and away from children.

ORDER OF ISSUANCE: III group of a pharmaceutical product sold without a prescription.

PACKAGING: Primary Packaging: 10 capsules on a blister. Secondary packaging: 4 blisters in a cardboard box.

Producer: "Neofarmi."

Georgia. Tbilisi. D. Agmashenebeli Highway 12th km.