Relief of gastrointestinal symptoms of functional non-ulcer dyspepsia (chronic gastritis), namely: flatulence; a feeling of rapid satiety; pain and discomfort in the upper abdomen; anorexia; heartburn; nausea; vomit.

Hypersensitivity to itopride hydrochloride or other components of the preparation. conditions in which increased contractile activity of the gastrointestinal tract may be harmful, for example, with gastrointestinal bleeding, mechanical obstruction, or perforation.

active substance: itopride hydrochloride;

1 tablet contains 50 mg of itopride hydrochloride;

excipients: lactose hydrate, corn starch, carmellose, anhydrous silicic acid, magnesium stearate;

tablet shell: hypromellose, macrogol 6000, titanium dioxide (E 171), carnauba wax.

For adults, the recommended dose of Ganaton is 150 mg/day (1 tablet (50 mg) 3 times a day before meals). the indicated dose can be reduced taking into account the patient's age and symptoms.

Itopride hydrochloride enhances the effect of acetylcholine and can show cholinergic side reactions. there are no data on long-term use. Itopride hydrochloride should be used with caution in elderly patients.

Use during pregnancy and breastfeeding. Itopride hydrochloride should not be used during pregnancy. Itopride hydrochloride passes into breast milk. An appropriate decision should be made to discontinue breast-feeding or to discontinue treatment, taking into account the importance of therapy to the mother.

Children. The safety of the use of itopride hydrochloride in children under the age of 16 has not been established.

The ability to influence the speed of reaction when driving a motor vehicle or working with other mechanisms. There is no information on the possible effect on reaction speed, but when deciding on the issue of driving vehicles or working with other mechanisms, the possibility of dizziness must be taken into account.

Metabolic interactions are not expected due to the fact that itopride hydrochloride is primarily metabolized by flavin monooxygenase and not by isoenzymes of the cytochrome p450 system.

No changes in protein binding were noted when used simultaneously with warfarin, diazepam, diclofenac, ticlopidine, nifedipine and nicardipine hydrochloride. Due to the fact that itopride hydrochloride strengthens the motility of the stomach, it can affect the absorption process of other medicines when used simultaneously. Care should be taken when using preparations with a low therapeutic index, dosage forms with delayed release or enteric coating.

Antiulcer preparations, such as cimetidine, ranitidine, teprenone and cetraxate, do not affect the prokinetic effect of itopride hydrochloride.

Anticholinergic preparations can reduce the effect of itopride hydrochloride.

Cases of overdose have not been reported.

Treatment. In case of overdose, it is necessary to take the usual measures of gastric lavage and carry out symptomatic treatment.

Adverse reactions reported in clinical trials. during clinical studies (i-iii phases) itopride hydrochloride was well tolerated, the development of serious adverse reactions was not reported. in total, 19 cases of adverse reactions were reported, which were noted in 14 of 572 patients, which is 2.4%. most of the indicated adverse reactions observed in more than 1 patient were: diarrhea (0.7%), headache (0.3%), abdominal pain (0.3%). deviations of laboratory parameters that were observed during clinical studies: a decrease in the level of leukocytes (leukopenia) (0.7%), an increase in the level of prolactin (0.3%).

Adverse reactions reported during postmarketing surveillance and clinical trials (ongoing) in patients treated with itopride hydrochloride

From the blood and lymphatic system: leukopenia, thrombocytopenia.

From the side of the immune system: anaphylactoid reactions.

From the endocrine system: increased prolactin level, gynecomastia.

From the side of the nervous system: dizziness, headache, tremor.

From the digestive system: diarrhea, constipation, abdominal pain, increased salivation, nausea.

From the side of the liver and biliary tract: jaundice.

From the skin and subcutaneous tissue: rash, redness, itching.

Laboratory studies: increase in the level of AsAT, AlAT, γ-glutamyl transpeptidase, LF, bilirubin.

Does not require special storage conditions.