Gafride Tablets (Itopride Hydrochloride)

Adult dose

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

This medication should not be used in patients who have had an allergic reaction to this drug or any of its components. It should not be administered to patients for whom stimulation of gastrointestinal motility may be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. Additionally, this drug contains lactose; therefore, it should not be used by patients with lactose intolerance, galactose intolerance, or congenital lactase deficiency. During the intake of this medication, severe allergic reactions such as shock or anaphylaxis may occur, so symptoms should be carefully monitored. If symptoms like hypotension, dyspnea, urticaria, or sweating occur, the medication should be stopped immediately, and consultation with a healthcare professional is necessary. As liver function impairment or jaundice symptoms may occur, regular liver function tests should be conducted, and the medication should be discontinued if abnormalities are found. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may also occur, so attention to these symptoms is required. Neuropsychiatric symptoms such as headache, anxiety, sleep disturbances, and dizziness may arise, so the condition should be observed closely. Endocrine disorders such as gynecomastia or elevated prolactin levels may appear, so if any abnormal symptoms arise, the medication should be stopped. Blood abnormalities such as thrombocytopenia or leukopenia may occur, so blood tests should be performed to regularly check the condition. This drug may affect kidney function; hence, BUN and creatinine levels should also be monitored. Hypersensitivity reactions such as skin rash, redness, and itching may rarely occur, and if these symptoms appear, the medication should be discontinued. Extrapyramidal symptoms like tremors may occur, so if any abnormal symptoms arise, medication should be stopped, and appropriate measures should be taken. Chest or back pain and fatigue may occur, so attention should be paid to one's physical condition. This medication enhances the action of acetylcholine, so this should be taken into account during use. If gastrointestinal symptoms do not improve, it is advisable not to use the drug for extended periods. Taking this medication with anticholinergics may reduce its effectiveness, so it should be used cautiously with intervals in between doses. Safety during pregnancy has not been established; therefore, pregnant women or those who may become pregnant should only use it after consulting a doctor and with caution. This drug may be excreted in breast milk, so it should be avoided, or breastfeeding should be discontinued if necessary during administration. Safety in children has not been sufficiently confirmed, so caution is required for use in this population. Elderly patients may have reduced physiological functions, making them more prone to adverse effects; thus, their condition should be monitored closely, and dosage adjustments or drug holidays may be necessary.

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

This medication is susceptible to air and moisture; therefore, it must be stored in a tightly sealed container. A storage temperature of between 1 degree and 30 degrees Celsius is recommended.

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle