Omez, lyophilizate 40 mg

Gastrointestinal infections caused by Helicobacter pylori, Heartburn, Reflux esophagitis, Peptic ulcer, Pain in the epigastric region, Nausea, Sour belching As an alternative to oral therapy if it is impossible:

• in gastric and duodenal ulcer disease (including prevention of relapse);
• in gastroesophageal reflux disease (GERD);
• with hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);
• for prevention and treatment of gastric and duodenal mucosal damage caused by taking non-steroidal anti-inflammatory drugs (NSAID gastropathy): dyspepsia, mucosal erosions, peptic ulcer;
• to prevent aspiration of acidic stomach contents into the airways during general anesthesia (Mendelsohn syndrome).

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Indications

As an alternative to oral therapy if it is not possible:
for peptic ulcers of the stomach and duodenum (including prevention of relapses);
for gastroesophageal reflux disease (GERD);
for hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);
for the prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of nonsteroidal anti-inflammatory drugs (NSAID gastropathy): dyspepsia, erosion of the mucous membrane, peptic ulcer;
to prevent aspiration of acidic stomach contents into the respiratory tract during general anesthesia (Mendelssohn syndrome).

Pharmacological effect

Pharmacodynamics

Special instructions

If a gastric ulcer is suspected in the early stages, it is necessary to undergo an X-ray or endoscopic examination to establish the correct diagnosis and prescribe adequate treatment.

In the presence of any alarming symptoms, such as significant spontaneous weight loss, frequent vomiting, dysphagia, hematemesis or melena, as well as in the presence of a gastric ulcer (or suspected gastric ulcer), the possibility of malignancy should be excluded, since treatment with Omez® may lead to improvement of symptoms and delay diagnosis.
Patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision, although a causal relationship between omeprazole/esomeprazole and osteoporotic fractures has not been established.

Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. Increased concentrations of CgA in blood plasma may affect the results of examinations to detect neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days before the CgA concentration study. If during this time the CgA concentration has not returned to normal, the study should be repeated.

During treatment with omeprazole, dizziness, drowsiness, and blurred vision may occur, so care should be taken when driving vehicles and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Omeprazole

Composition

Each bottle contains:

Pregnancy

The use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug.

Side Effects

The frequency of adverse drug reactions is presented in accordance with the following gradation: very often (>1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000, including isolated cases).

Interaction

Long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to changes in their concentrations in the blood plasma.

Overdose

Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.

Treatment: symptomatic. Hemodialysis is not effective enough.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ºС.

Shelf life

2 years

Manufacturer

Colep Consumer Products Portugal S.A., Portugal