tablets "Neksium" are applied at indications which are provided below.

Adult:

• gastroesophageal reflux disease (GERD):
  • treatment erosive reflux esophagitis;
  • long-term treatment of patients with the cured esophagitis for prevention of a recurrence;
  • symptomatic treatment of a gastroesophageal reflux disease (GERD);
• in combination with the appropriate antibacterial medicines for Helicobacter pylori eradikation:
  • treatment of an ulcer of the duodenum caused by Helicobacter pylori;
  • prevention of a recurrence of round ulcers at patients with the ulcers caused by Helicobacter pylori;
• patients demanding prolonged use of non-steroidal anti-inflammatory medicaments (NPVP):
  • healing of the stomach ulcers caused by use of NPVP;
  • prevention of the stomach ulcers and a duodenum caused by use of NPVP for patients, relating to risk group;
• long-term treatment after intravenous use of medicament for prevention of a recurrence of bleeding from round ulcers;
• treatment of a syndrome of Zollingera-Ellison.

Children aged from 12 years:

• gastroesophageal reflux disease (GERD):
  • treatment erosive reflux esophagitis;
  • long-term treatment of patients with the cured esophagitis for prevention of a recurrence;
  • symptomatic treatment of a gastroesophageal reflux disease (GERD);
• in combination with antibiotics at treatment of an ulcer of the duodenum caused by Helicobacter pylori.

Structure

Active ingredient - esomeprazole (an odga the tablet, coated, contains magnesium esomeprazole trihydrate that corresponds to 40 mg of esomeprazole).

Excipients: glitserol monostearate, hydroxypropyl cellulose, a gipromelloza, magnesium stearate, methacrylate copolymer (type A), cellulose microcrystalline, paraffin synthetic, a macrogoal, polysorbate 80, krospovidon, the sodium stearylfumarating sugar spherical, talc, the titan dioxide (E 171), triethyl citrate, ferrous oxide henna-red (E 172).

Contraindication

• hypersensitivity to active ingredient, the substituted benzimidazoles or to any of excipients;
• esomeprazole should not be applied along with nelfinaviry.

Route of administration

Gastroesophageal reflux disease (adult)

Treatment erosive reflux esophagitis: 40 mg once a day within 4 weeks. Patients with not cured esophagitis or resistant symptoms are recommended to use in addition medicament within 4 weeks.

Long-term treatment of patients with the cured esophagitis for prevention of a recurrence: 20 mg once a day.

Symptomatic treatment of a gastroesophageal reflux disease (GERD). The dose for patients without esophagitis makes 20 mg once a day. If after 4 weeks of treatment of control over symptoms the patient did not manage to reach, it is necessary to undergo additional inspection. After disappearance of symptoms for their further control there can be sufficient a use of 20 mg once a day. If necessary it is possible to pass to administration of medicament in the mode "on demand", that is to use medicament on 20 mg once a day. Drug use "as necessary" for the subsequent control of symptoms is not recommended to patients with risk of developing the stomach ulcers and a duodenum accepting NPVP.

In combination with the appropriate antibacterial medicines for Helicobacter pylori eradikation (adult)

Also for treatment of an ulcer of the duodenum caused by Helicobacter pylori and prevention of a recurrence of round ulcers at patients with the ulcers caused by Helicobacter pylori: 20 mg of the medicament "Neksium" with one of amoxicillin and 500 mg of a klaritromitsin twice a day within 7 days.

Patients demanding prolonged use of non-steroidal anti-inflammatory medicaments (NPVP) (adult)

Treatment of stomach ulcer, NPVP caused by use: the usual dose makes 20 mg once a day. Duration of treatment is 4-8 weeks.

Prevention of the stomach ulcers and a duodenum caused by use of NPVP for patients, relating to risk group: 20 mg once a day.

Long-term treatment after intravenous use of medicament for prevention of a recurrence of bleeding from round ulcers (adult)

Recommended dose - 40 mg once a day within 4 weeks after intravenous use of medicament for prevention of a recurrence of bleeding from round ulcers.

Treatment of a syndrome of Zollingera-Ellison (adult)

Recommended initial dose of the medicament "Neksium" makes 40 mg twice a day. Further the dose is adjusted individually; treatment continues as long as it is demanded by clinical indications. Proceeding from the available clinical data, at most of patients the control of a state can be reached at doses from 80 to 160 mg of esomeprazole a day. If doses exceed 80 mg a day, the dose should be divided and applied twice a day.

Gastroesophageal reflux disease (children are more senior than 12 years)

Treatment erosive a reflux esophagitis: 40 mg once a day within 4 weeks. Patients with not cured esophagitis or resistant symptoms are recommended to use in addition medicament within 4 weeks.

Long-term treatment of patients with the cured esophagitis for prevention of a recurrence: 20 mg once a day.

Symptomatic treatment of a gastroesophageal reflux disease (GERD). The dose for patients without esophagitis makes 20 mg once a day. If after 4 weeks of treatment of control over symptoms the patient did not manage to reach, it is necessary to undergo additional inspection. After stopping of symptoms the subsequent control over them can be reached by use of medicament in a dose of 20 mg once a day.

Treatment of an ulcer of the duodenum caused by Helicobacter pylori (children are more senior than 12 years)

When choosing the corresponding combination therapy should consider official nation-wide, regional and local recommendations about bacterial resistance, treatment duration (usually - 7 days, but sometimes - up to 14 days) and appropriate use of antibacterial drugs. Treatment has to be carried out under observation of the expert.

Recommendation about a medicament dosage:

• body weight of 30-40 kg - in combination with two antibiotics: Neksium of 20 mg, amoxicillin of 750 mg and klaritromitsin 7.5 mg/kg of body weight - all medicaments are used at the same time two times a day within a week;
• body weight> 40 kg: in combination with two antibiotics: Neksium of 20 mg, amoxicillin of 1 g and klaritromitsin 500 mg - all medicaments are used at the same time two times a day within a week.

Feature of use

Pregnant

with care medicament to pregnant women.

Esomeprazole should not be applied during feeding by a breast.

lack of influence of omeprazolum on fertility in case of oral administration of drug.

Drivers

Esomeprazole has the minimum impact on ability to run vehicles or to work with other mechanisms. It is reported about such side reactions as dizziness (rarely) and illegibility of sight (seldom). If such disorders are observed, patients should not run vehicles or to work with other mechanisms.

Now data on deliberate overdose are very limited to

. The symptoms described at administration of medicament in a dose of 280 mg included symptoms from digestive tract and weakness. Single intake of esomeprazole in a dose of 80 mg did not cause any negative consequences. Specific antidote is unknown. Esomeprazole considerably contacts proteins of blood plasma therefore a conclusion by means of dialysis is insignificant. As well as at any overdose it is necessary to provide the symptomatic and general supporting treatment.

Side effects

Among side effects most of which often meet during conduct of clinical trials (and also during postregistration use of drug), are noted a headache, an abdominal pain, diarrhea and nausea.

to Store

at a temperature not above 30 °C, out of children's reach. To store in the blister for the purpose of protection against moisture penetration.

Expiration date - 3 years.