Itopride Tablets (Itopride Hydrochloride)

Adult dose

Adults: Administer itopride hydrochloride 50 mg orally 3 times daily before meals. Adjust the dose as appropriate according to symptoms.

This medication should not be used in patients who have had allergic reactions to it or its components. It should also not be administered to patients for whom gastrointestinal motility stimulation may be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. This medication contains lactose, which should not be used in patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Serious allergic reactions such as shock or anaphylaxis may occur during treatment, so if symptoms arise, administration should be stopped immediately and appropriate treatment should be sought. Liver dysfunction or jaundice may occur, so regular liver function tests should be conducted, and administration should be stopped if any abnormalities are found. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, and neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness have also been reported. Endocrine disturbances such as gynecomastia or elevated prolactin levels may occur, and if symptoms arise, administration should be discontinued. Thrombocytopenia or leukopenia may occur, so regular blood tests should be conducted to monitor the condition. Blood test values indicating changes in kidney function may also increase, necessitating caution. Rarely, hypersensitivity reactions such as skin rash, itching, and erythema may occur, and if these symptoms arise, administration should be stopped. Extrapyramidal symptoms, such as tremors, may occur, so immediate action should be taken if any unusual signs are observed. Chest pain or fatigue may occasionally occur, so the patient's condition should be closely monitored. This medication enhances the action of acetylcholine, so this should be considered during use, and prolonged use is not recommended if gastrointestinal symptoms do not improve. When taken with anticholinergics, the effectiveness of this medication may be reduced, so care should be taken to adjust the dosing interval. Women who are pregnant or may become pregnant should only use this medication when the benefits of treatment outweigh the risks, as its safety has not been established. Nursing mothers should avoid this medication as it may be secreted in breast milk; if it must be used, breastfeeding should be suspended. The safety in children has not been fully confirmed, so this medication should be administered with caution in pediatric patients. Elderly patients may experience adverse reactions more easily due to decreased body function, so careful observation is necessary during administration, and dosage adjustments or discontinuation may be needed. This medication should be stored out of reach of children, and caution should be exercised to avoid transferring it to other containers, as this may pose a risk of accidents or alter the quality of the medication.

• Shock
• anaphylactic-like symptoms
• hypotension
• difficulty breathing
• laryngeal edema
• urticaria
• pallor
• sweating
• liver dysfunction
• jaundice

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is best to store it at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 tablets/bottle