Topiride Tablets (Itopride Hydrochloride)

Adult dose

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

This medication should not be used in patients who have a history of allergy or hypersensitivity to this medication or its components. It should not be administered to patients for whom gastrointestinal motility stimulation could be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. This medication contains lactose, so it should not be used in patients with lactose intolerance or certain genetic metabolic disorders. While using this medication, serious allergic reactions such as shock or anaphylaxis can occur, so symptoms should be closely monitored. Regularly check liver health status as liver dysfunction or jaundice symptoms may occur. Gastrointestinal symptoms such as nausea, diarrhea, constipation, and abdominal pain may appear, along with neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness. Endocrine disturbances such as gynecomastia or increased prolactin levels may occur, and periodic testing is necessary as thrombocytopenia or leukopenia may be found in blood tests. As it may affect kidney function, kidney-related tests should be performed. Rarely, hypersensitivity reactions such as skin rash and pruritus may occur, and symptoms such as body trembling or tremors should be reported immediately to healthcare professionals. As it enhances acetylcholine action, this should be considered when using the medication, and long-term use should be avoided if gastrointestinal symptoms do not improve. When taken with anticholinergics, the efficacy may be reduced, so caution is needed to adjust the dosing intervals. Pregnant women or those who may become pregnant should only use this medication if the benefit outweighs the risk, as its safety has not been established. During breastfeeding, as this medication may be secreted into breast milk, it should be avoided if possible, and in unavoidable cases, breastfeeding should be discontinued. Safety in children has not been sufficiently verified, so it should be used with caution. Elderly patients may experience adverse reactions more easily due to decreased physiological function, so symptoms should be closely monitored, and doses may need to be adjusted or temporarily discontinued if necessary. This medication should be kept in a safe place out of reach of children, and transferring it to another container can cause accidents or quality degradation, so caution is advised.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. By doing so, the medication's effectiveness can be maintained for a longer period.

Appearance

White round film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle