Itoran Tablets (Itopride Hydrochloride)

Adult dose

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

This medication 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 with conditions in which gastrointestinal motility stimulation may be harmful, such as gastrointestinal bleeding, mechanical obstruction, or perforation. Additionally, this medication contains lactose, so patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. During use, careful observation is needed as serious allergic reactions such as shock or anaphylaxis may occur. Liver dysfunction or jaundice symptoms may appear, so regular liver function tests should be conducted, and if any abnormal signs occur, administration should be stopped immediately. Gastrointestinal adverse reactions such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur. CNS symptoms such as headache, anxiety, sleep disturbances, and dizziness may also appear; caution is necessary. Gynecomastia symptoms or elevated prolactin levels may occur, so if any unusual symptoms arise, consultation with a physician is advised. Hematologic issues like thrombocytopenia or leukopenia may also occur, necessitating regular blood tests. Renal function may be affected, so kidney-related tests are also recommended. Rarely, hypersensitivity reactions such as skin rash, itching, or erythema may occur; if any unusual symptoms arise, the medication should be stopped, and a doctor's evaluation should be sought. Extrapyramidal symptoms such as tremors may occur, so caution is advised. Chest pain or fatigue may manifest; if these symptoms persist, consultation with a physician is crucial. This medication increases acetylcholine action, which should be considered during use, and if gastrointestinal symptoms do not improve, long-term use is discouraged. When taken with anticholinergics, the effectiveness of this medication may be reduced, so it should be used cautiously with intervals in administration. Safety during pregnancy has not been established; therefore, women who are pregnant or may become pregnant should consult a physician before use. If breastfeeding, as this medication may be excreted in breast milk, it is advisable to avoid administration, and if it must be administered, breastfeeding should be suspended. Safety in pediatric patients has not been sufficiently verified, so caution is warranted when administering to children. Elderly patients may be more susceptible to adverse reactions due to reduced physiological function, so symptoms should be monitored carefully, and dosage may need to be adjusted or temporarily discontinued as necessary. This medication should be kept out of reach of children and should not be transferred to other containers, as this could lead to accidents and may adversely affect quality.

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

This medication must be stored in a tightly sealed container to protect it from air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the efficacy and safety of the medication over time.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle