Samsing Itopride Tablets (Itopride Hydrochloride)

Adult dose

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

This medication should not be used in patients with a history of allergic reactions to this drug or its components. Patients with gastrointestinal bleeding, mechanical obstruction, perforation, or other issues should not be administered this medication as it may promote gastrointestinal motility. Additionally, because this drug contains lactose, it should not be given to patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. When using this drug, serious allergic reactions such as shock or anaphylaxis may occur, so symptoms should be carefully monitored. If low blood pressure, difficulty breathing, hives, pallor, excessive sweating, or similar symptoms occur, administration should be stopped immediately, and appropriate treatment should be sought. If liver enzyme levels rise or jaundice symptoms appear, the use of this medication should be stopped and medical attention should be sought, as it may adversely affect liver function. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, so attention should be paid to these symptoms. Neurological symptoms such as headache, restlessness, sleep disturbances, and dizziness may occur; reports should be made if unusual symptoms arise. Endocrine abnormalities like gynecomastia or elevated prolactin levels may occur; treatment may need to be discontinued if these symptoms appear. Regular blood tests should be conducted to check for thrombocytopenia or leukopenia. Since it may affect kidney function, it's advisable to periodically check BUN and creatinine levels. Rarely, hypersensitivity reactions such as skin rash, redness, and itching may occur, and administration should be discontinued if unusual symptoms arise. Extrapyramidal symptoms such as tremors may occur; monitoring for these symptoms is essential. This medication enhances acetylcholine action, so this should be taken into consideration during use. If gastrointestinal symptoms do not improve, long-term use should be avoided. If used with anticholinergics, the effect of this drug may be reduced, so caution should be exercised in managing the dosing interval. Pregnant women or women who may become pregnant should only use this medication if the benefits outweigh the potential risks, as its safety has not been established. During breastfeeding, this medication may be excreted in breast milk, so use should be avoided; if unavoidable, breastfeeding should be discontinued. Safety in children has not been sufficiently established, so caution in use is advised. Elderly patients may experience atypical reactions due to decreased physical function, so symptoms should be monitored closely and the dosage adjusted as needed. This medication should be kept out of the reach of children, and care should be taken not to transfer it to other containers as this may alter its quality.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best to avoid direct sunlight and store it at room temperature between 1°C and 30°C.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle