Hytos Tablets (Itopride Hydrochloride)

Adult dose

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

This medication should not be used in patients who have had an allergic reaction to this drug or its components. It should also not be administered to patients with conditions where gastrointestinal stimulation could be harmful, such as gastrointestinal bleeding, mechanical obstruction, or perforation. This medication contains lactose, so it should not be used in patients with genetic disorders such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Serious allergic reactions such as shock or anaphylaxis may occur while using this medication, so if symptoms such as hypotension, dyspnea, angioedema, hives, pallor, or excessive sweating occur, stop administration immediately and seek appropriate treatment. Liver function impairment or jaundice symptoms may occur, so liver function should be carefully monitored, and if abnormalities are found, the medication should be discontinued. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur. Psychoneurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may occasionally occur. Endocrine symptoms such as gynecomastia or elevated prolactin levels may also appear; if such symptoms arise, the medication should be discontinued. Thrombocytopenia or leukopenia may occur, so regular blood tests should be performed to check for abnormalities, and if found, administration should be stopped. This medication may affect kidney function, potentially leading to increased BUN or creatinine levels. Liver enzyme levels (AST, ALT, γ-GTP, ALP) may be elevated, so liver health should be carefully observed. Allergic reactions such as rash, erythema, and itching may rarely occur; if these symptoms appear, administration should be ceased. Extrapyramidal symptoms such as tremors or rigidity may occur, so discontinue the medication if abnormal symptoms appear. Chest or back pain and fatigue may occasionally occur. This medication enhances acetylcholine activity; therefore, it should be used with consideration, and long-term use should be avoided if gastrointestinal symptoms do not improve. The effectiveness of this medication may be reduced when taken with anticholinergic agents, so it should be used cautiously with an appropriate interval. Safety during pregnancy has not been established; thus, women who are pregnant or may become pregnant should only use this medication if the benefits outweigh the risks. During breastfeeding, this medication may be secreted into breast milk, so it should be avoided if possible, and if it must be used, breastfeeding should be discontinued. Safety in children has not been adequately established; therefore, it should be used with caution. Elderly patients may experience abnormal reactions more easily due to decreased bodily functions; thus, symptoms should be monitored closely, and dosages should be reduced or administration discontinued if necessary. This medication should be kept out of reach of children, and transferring it to another container may lead to accidents or affect the quality, so it should be stored in its original container.

• Shock
• anaphylactic-like symptoms
• hypotension
• respiratory distress
• laryngeal edema
• urticaria
• pallor
• sweating
• hepatic dysfunction
• jaundice

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps maintain the efficacy of the medication and prevents deterioration.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle