Publisher: PRO.MED.CS Praha a.s., Telฤskรก 377/1, Michle, 140 00 Praha 4, Czech Republic
Treatment of gastrointestinal symptoms of functional, non-ulcer dyspepsia, like feelings of bloating, gastric fullness, discomfort to pain in epigastrium, anorexia, heartburn, nausea and vomiting.
The medicinal product is intended for adults.
The recommended dose for adults is 150 mg daily, i.e. 1 tablet 3 times a day before meal. This dose can be reduced if required in the course of disease. The exact dosage and duration of treatment depends on the clinical state of the patient. The duration of the administration in clinical studies was maximally 8 weeks.
The safety and efficacy of itopride in paediatric population has not been established.
Itopride is metabolised in liver. Itopride and its metabolites are excreted mainly via kidneys. Patients with reduced hepatic or renal functions should be carefully monitored and in case of adverse reactions it is necessary to take appropriate measures, as e.g. to reduce the dosage or to discontinue the therapy.
It was shown in clinical studies that the incidence of adverse effects in patients aged 65 years and older was not higher than in younger patients. Itopride should be administered in elderly patients with adequate caution because of increased incidence of hepatic and renal function disorders, other diseases or treatment with additional drugs.
Tablets should be swallowed whole with a sufficient amount of liquid.
Overdose was not experienced in humans. In case of overdose the usual measures of gastric lavage and symptomatic therapy should be applied.
5 years.
This medicinal product does not require any special storage conditions.
OPA/Al/PVC/Al blister or transparent PVC/PVdC/Al blister, carton.
Pack size: 10, 20, 30, 40, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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