GASTROMEG® EZO
GASTROMEG® EZO

Инструкция по применению

Для специалистов здравоохранения

Indications

Adults:

Gastroesophageal reflux disease (GERD): 

- Treatment of erosive reflux esophagitis;

- long-term maintenance treatment after healing of erosive reflux esophagitis to prevent recurrence;

- symptomatic treatment of gastroesophageal reflux disease.

As part of combined therapy: 

- Treatment of duodenal ulcer associated with Helicobacterpylori;

- prevention of recurrences of peptic ulcer associated with Helicobacterpylori.

- Long-term acid-suppressive therapy in patients who have undergone bleeding fr om peptic ulcer (after intravenous administration of drugs decreasing gastric gland secretion to prevent recurrence).

Patients taking NSAIDs for a long time:

- healing of gastric ulcer associated with NSAID intake;

- prevention of gastric and duodenal ulcers associated with NSAID intake in patients at risk.

- treatment of Zollinger-Ellison syndrome.

The drug is used in adolescents over 12 years of age:

Gastroesophageal reflux disease (GERD):

- Treatment of erosive reflux esophagitis;

- long-term maintenance treatment after erosive reflux esophagitis has healed to prevent recurrence;

- symptomatic treatment of gastroesophageal reflux disease.

In combination with antibiotics in the treatment of duodenal ulcer caused by Helicobacterpylori:

- Gastroesophageal reflux disease (GERD);

- erosive reflux esophagitis;

- bleeding from a peptic ulcer;

- Zollinger-Ellison syndrome;

- as part of combination therapy: gastric and 12-perintestinal ulcer disease associated with Helicobacterpylori (treatment and prophylaxis).


Information on proper use


How to use and dosage


Oral capsules.

The medicine should be taken without chewing and with a small amount of liquid.

Adults:

Gastroesophageal reflux disease (GERD)

Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. An additional 4-week course of treatment is recommended in cases wh ere healing of esophagitis does not occur after the first course or symptoms persist.

Long-term maintenance treatment after healing of erosive reflux esophagitis to prevent recurrence: 20 mg once daily.

Symptomatic treatment of gastroesophageal reflux disease: 20 mg once daily for patients without esophagitis. If after 4 weeks of treatment the symptoms do not disappear, the patient should be further evaluated. After elimination of symptoms it is possible to switch to the "as needed" regimen, i.e. to take the medicinal product Gastromeg® EZO 20 mg once a day in case of symptoms recurrence.

As a part of combined therapy 

Treatment of Helicobacterpylori-associated duodenal ulcer and prevention of recurrence of Helicobacterpylori-associated peptic ulcers: Gastromeg® EZO 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All medications are taken twice daily for 7 days.

Healing of gastric ulcer associated with taking NSAIDs: the usual dose is 20 mg once daily. The duration of treatment is 4-8 weeks. 

Prevention of gastric and duodenal ulcers associated with NSAID intake in patients at risk: 20 mg or 40 mg once daily.

Long-term therapy for the prevention of recurrences after ongoing treatment of peptic ulcer: 40 mg once daily for 4 weeks.

Treatment of Zollinger-Ellison syndrome: the recommended initial dose is Gastromeg® EZO 40 mg twice daily. Further the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is experience in the use of esomeprazole in doses up to 80 - 160 mg per day. At a dose above 80 mg per day it should be divided into two doses.

Special groups of patients

Patients with renal insufficiency: no dose adjustment of the drug is required. Due to limited experience of use in patients with severe renal insufficiency, the drug Gastromeg® EZO should be administered with caution in this group.

Patients with hepatic insufficiency: in case of mild and moderate hepatic insufficiency no dosage adjustment of the medicinal product is required. For patients with severe hepatic insufficiency the maximum daily dose of 20 mg should not be exceeded.

Elderly patients: no dose adjustment of the medicinal product is required.

Adolescents over 12 years of age:

Gastroesophageal reflux disease (GERD)

Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. An additional 4-week course of treatment is recommended in cases when after the first course healing of esophagitis does not occur or symptoms persist.

Long-term maintenance treatment after healing of erosive reflux esophagitis to prevent recurrence: 20 mg once daily.

Symptomatic treatment of gastroesophageal reflux disease: 20 mg once daily in patients without esophagitis. If after 4 weeks of treatment symptoms do not disappear, the patient should be further evaluated. After elimination of symptoms it is possible to switch to the "as needed" regimen, i.e. to take the medicinal product Gastromeg® EZO 20 mg once a day in case of renewal of symptoms.

To prevent gastric and duodenal ulcers caused by NSAID therapy, the dose is 20 mg once a day for patients at risk.

Treatment of Helicobacterpylori-associated duodenal ulcers

When selecting appropriate combination therapy, official national, regional, and local recommendations regarding bacterial resistance, duration of therapy (most often 7 days, sometimes up to 14 days), and appropriate use of antibacterial drugs should be considered. Treatment should be carried out under the supervision of a physician.

Children under 12 years of age

This medicinal product should not be used in children under 12 years of age, as data on such use are not available.