Newpeshin Tablet 5mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including the elderly) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used in patients with urinary retention, severe gastrointestinal diseases, myasthenia gravis, or narrow-angle glaucoma. It is also not safe for patients with allergies to this medication or its components, those undergoing hemodialysis, and patients with severe hepatic or renal impairment. Caution is advised when used in patients at risk of urinary retention or with gastrointestinal obstructive diseases or decreased gastrointestinal motility. Patients with severe renal impairment, moderate hepatic impairment, or those taking strong CYP3A4 inhibitors should also have their dosage limited or monitored. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly, dry mouth and constipation may occur more frequently with higher doses, so caution is needed. Severe gastrointestinal adverse reactions such as fecal impaction, colonic obstruction, and intestinal obstruction have been reported; if these symptoms occur, consult a physician immediately. This medication can cause serious allergic reactions such as angioedema or anaphylaxis; if symptoms appear, discontinue use and seek treatment immediately. Patients with heart disease or electrolyte imbalances may have an increased risk of arrhythmias while taking this medication, so caution is required. Be aware that symptoms such as drowsiness, blurred vision, and fatigue may occur when driving or operating machinery. The effectiveness may be enhanced or side effects may increase when used with other anticholinergic medications, so caution is advised when combined. This medication interacts with drugs that increase gastrointestinal motility, potentially reducing its effectiveness. Since this medication is primarily metabolized by hepatic CYP3A4 enzymes, dosage adjustment may be necessary when taken with drugs that strongly inhibit this enzyme. Women who are pregnant should use this medication cautiously as its safety has not been established, and nursing mothers should avoid it as it may pass into breast milk and affect the newborn. Safety in children has also not been confirmed, so it should not be administered to pediatric populations. In cases of overdose, symptoms such as changes in consciousness, headache, dizziness, drowsiness, and blurred vision may occur, and immediate medical treatment should be sought. Gastric lavage or activated charcoal may be needed in cases of overdose, and in severe instances, artificial respiration or anticonvulsant treatment may be required. It is important to inform the physician of any history of heart disease, renal or hepatic function status, and allergies before taking this medication, and to regularly monitor for adverse reactions.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• dyspepsia
• epigastric pain
• vomiting
• urinary tract infection

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to store the medication at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness safely.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP*10)]