SPC Nizatidine Tablet

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, in the morning and evening, orally. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. In cases of active gastric ulcers, malignancy must be ruled out before treatment. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results of longer-term administration are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dosage adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg daily; < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day; < 20 ml/min: 150mg every 3 days Some elderly patients may have a creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should be reduced in these patients as well to account for decreased renal function. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

This medication should not be used in certain patients. Patients who have had allergic reactions to this drug or similar drugs should not take it. This drug should be used cautiously in patients with a history of allergic reactions, poor liver function, and impaired kidney function. In particular, patients with poor kidney function may retain the drug in their body for a long time, necessitating a reduction in dosage or an increase in the dosing interval. While rare, symptoms such as skin rashes, itching, difficulty breathing, and severe allergic reactions may occur, and if these symptoms appear, use should be discontinued immediately. Blood abnormalities can lead to anemia or changes in white blood cell counts; in such cases, the use of the medication should also be stopped. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may occur. There is a rare possibility of elevated liver function test results or liver issues such as hepatitis or jaundice. Psychological confusion, headache, drowsiness, dizziness, and weakness may occur rarely, and in severe cases, seizures can happen. There may be a temporary increase in heart rate. In women, symptoms such as breast enlargement may occur rarely, and in men, erectile dysfunction or decreased libido have been reported. Skin-related side effects such as sweating, hives, rashes, dermatitis, and rarely vasculitis may occur. Additionally, symptoms unrelated to gout or kidney stones, such as elevated uric acid levels, fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough have been reported. This drug can conceal symptoms of stomach cancer, so it is important to confirm that it is not cancer before use. Because it is primarily excreted through the kidneys, patients with impaired kidney function may need dosage adjustments. If no therapeutic effects are observed, it is advisable to switch to another medication, and regular blood tests or liver and kidney function tests should be conducted during treatment. Pregnant or breastfeeding women should use this drug only when its safety is fully confirmed and under a doctor's judgment if absolutely necessary. The safety and efficacy for children have not been adequately established. Elderly individuals often have impaired kidney function, so kidney function tests should be performed before use, and kidney status should be closely monitored during treatment. This drug may affect some clinical test results, so caution is needed when interpreting test results. In case of overdose, symptoms such as vomiting, diarrhea, and pupil constriction may appear, and emergency treatment such as activated charcoal administration or gastric lavage may be required. This drug has minimal interactions with other medications, but when used with high-dose aspirin, it may affect blood drug concentrations.

• rash
• itching
• bronchial asthma
• laryngeal swelling
• anaphylactic symptoms
• anemia
• leukopenia
• neutrophilia
• thrombocytopenic purpura
• constipation

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is advisable to store it at room temperature between 15 degrees and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle