Source: Medicines Authority (MT) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Toprisan is indicated in adults as atreatment of gastrointestinal symptoms in functional, non-ulcer dyspepsia (chronic gastritis), such as: flatulence, gastric fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting.
The recommended daily dose for adults is 150 mg daily, i.e. 1 tablet 3 times a day before meals. This dose may be reduced depending on the patient’s age and symptoms (see section 4.4).
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 precaution because of increased incidence of hepatic and renal function disorders, other diseases or treatment with additional drugs.
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.
The duration of administration of itopride during clinical studies was of maximum 8 weeks.
If there is no improvement in gastrointestinal symptoms, Toprisan should not be used more than 8 weeks.
Oral use. The tablets should be taken before meals.
Itopride overdose in humans has not been reported. In the case of a large overdose, standard measures are needed, such as gastric lavage and symptomatic treatment.
30 months.
This medicinal product does not require any special storage conditions.
Clear PVC/PE/PVDC-Alu blisters and Clear PVC/PVDC-Alu blisters.
The available pack sizes are: 20, 30, 40 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Avoid release in environment.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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