International Itorride Tablet (Itopride Hydrochloride)

Adult dose

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

This medication should not be administered to patients who have had an allergic reaction to it or its components. It should also not be used in patients where gastrointestinal motility may be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. Serious allergic reactions such as shock or anaphylaxis may occur during the use of this medication, so symptoms should be monitored closely. If hypotension, difficulty in breathing, laryngeal edema, hives, pallor, or excessive sweating occur, the medication should be stopped immediately and appropriate treatment sought. Due to the potential for liver function impairment or jaundice, regular liver function tests should be conducted, and if abnormalities are found, the medication should be discontinued. Gastrointestinal adverse effects such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur. Central nervous system symptoms such as headache, anxiety, sleep disturbances, and dizziness may also arise, requiring careful attention. Gynecomastia or elevated prolactin levels may occur, so any unusual symptoms should be discussed with a physician. Blood abnormalities such as thrombocytopenia or leukopenia may occur, necessitating regular blood tests to monitor the condition. Renal function may be affected, with potential increases in serum BUN and creatinine levels, requiring caution. Rarely, hypersensitivity reactions such as skin rash, erythema, and itching may present, and should severe symptoms occur, the medication should be discontinued. Tremors may occur as a symptom affecting motor control, and the medication should be stopped if symptoms are severe. Occasionally, chest or back pain and fatigue may be noted, and if these symptoms persist, consultation with a healthcare professional is recommended. If gastrointestinal symptoms do not improve, it is important not to continue long-term use of this medication. This medication enhances the action of the neurotransmitter acetylcholine, which should be taken into consideration when using. When taken together with anticholinergics, the effect of this medication may be diminished, so it should be used with caution, maintaining time intervals between doses. Safety has not been established during pregnancy, so women of childbearing potential should carefully weigh the benefits and risks before using this medication. During breastfeeding, this medication may be secreted in breast milk, so use should be avoided if possible, and if unavoidable, breastfeeding should be discontinued. Safety in pediatric patients has not been sufficiently established, so caution is advised when used in this population. Elderly patients may experience adverse reactions more easily due to decreased physical functions, so symptoms should be observed closely, and dosage adjustments may be necessary. This medication should be kept out of reach of children, and transferring it to other containers should be avoided due to the risk of accidents and degradation of quality.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, it is important to maintain room temperature, specifically between 1 to 30 degrees Celsius, to preserve its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle