Ganitofen 50 mg (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 by those who have experienced allergic reactions to this medication or its components. Additionally, it should not be administered to patients where gastrointestinal motility stimulation may be harmful, such as those with gastrointestinal bleeding, mechanical bowel obstruction, or perforation. As this medication contains lactose, it should not be used by patients with genetically determined disorders that impede lactose digestion. Serious allergic reactions, such as shock or anaphylaxis, may occur during use of this medication; if symptoms such as hypotension, difficulty breathing, or hives appear, administration should be stopped immediately, and appropriate treatment should be sought. Since liver dysfunction or jaundice symptoms may occur, regular liver function tests should be conducted, and if unusual signs appear, administration should be halted. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, and neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may also be experienced. Gynecomastia symptoms or elevated prolactin levels may occur; if such changes happen, consulting a doctor is necessary. Blood abnormalities such as thrombocytopenia or leukopenia may arise, so blood tests should be done regularly to check the condition. This medication may affect kidney function, so monitoring blood BUN and creatinine levels is advised. Rarely, hypersensitivity reactions such as skin rash, itching, and redness may occur; if there are any unusual symptoms, the medication should be stopped. Symptoms such as tremors, chest pain, and fatigue have also been reported, so these should be communicated to healthcare providers if they arise. This medication enhances acetylcholine action; therefore, this should be considered during use, and if gastrointestinal symptoms do not improve, long-term use should be avoided. If taken with anticholinergic drugs, the efficacy of this medication may be decreased, so caution is needed regarding dosing intervals. Pregnant women or those who may become pregnant should only use this medication if absolutely necessary, as its safety has not been established; during breastfeeding, use should be avoided if possible or breastfeeding should be halted. Safety has not been sufficiently verified for children, so caution should be exercised when using it in this population. Elderly patients may exhibit more adverse reactions due to decreased bodily function; thus, symptoms should be closely monitored, and dosages should be adjusted or administration stopped as necessary. This medication should be stored out of the reach of children, and care should be taken to avoid transferring it to other containers which may lead to accidents or quality degradation.

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

This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. Additionally, avoid storing in excessively hot or cold locations, and it is safest to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 tablets/bottle