Winatone 50 mg Tablet (Itopride Hydrochloride)

Adult dose

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

This medicine should not be used in patients who have had allergic reactions to this medication or its components. It should also not be administered to patients who may be harmed by gastrointestinal stimulation due to gastrointestinal bleeding, mechanical obstruction, or perforation. Additionally, since this medication contains lactose, it is advisable not to use it in patients with lactose intolerance or specific genetic issues. Serious allergic reactions such as shock or anaphylaxis may occur during treatment, so symptoms should be closely monitored. Because liver function may be affected, liver enzyme changes should be carefully monitored, and if problems are found, the medication should be discontinued. Gastrointestinal symptoms such as nausea, diarrhea, constipation, and abdominal pain may occur; if discomfort persists, consultation with a physician is recommended. Neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may also occur, necessitating caution. Endocrine disorders such as gynecomastia or increased prolactin levels have also been reported; if abnormal symptoms occur, the medication should be discontinued. Blood-related issues such as thrombocytopenia or leukopenia may occur, so regular blood tests are necessary. This medication may affect kidney function, so BUN and creatinine levels should also be monitored. In rare cases, hypersensitivity reactions such as skin rashes or itching may occur, and if symptoms arise, the medication should be stopped. If extrapyramidal symptoms such as tremors occur during treatment, a doctor should be consulted immediately. Chest or back pain and fatigue may manifest, so if these symptoms persist, medical personnel should be informed. As this medication enhances the action of acetylcholine, it should be used with this consideration in mind; if gastrointestinal symptoms do not improve, prolonged use should be avoided. If taken with anticholinergics, the effectiveness of this medication may be reduced, so caution should be taken regarding dosage intervals. Pregnant women or those who may become pregnant should use this medication only when necessary, as its safety has not been established. During breastfeeding, this medication may be secreted into breast milk; it should preferably be avoided, and if unavoidable, breastfeeding should be suspended. In children, safety has not been sufficiently established, so it should be used with caution. In the elderly, as physical functions are diminished, the risk of adverse reactions is heightened, necessitating careful observation and dose adjustments if needed. This medication should be stored out of reach of children and not transferred to other containers.

• Shock
• symptoms resembling anaphylaxis
• hypotension
• dyspnea
• laryngeal edema
• urticaria
• pallor
• sweating
• hepatic dysfunction
• jaundice

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle