Newpessin Tablet 10mg (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 by patients with urinary retention symptoms. Patients with toxic megacolon or severe gastrointestinal issues should also not be administered this medication. It is contraindicated for patients with myasthenia gravis and narrow-angle glaucoma. Patients allergic to this medication or its components should avoid use. Patients undergoing hemodialysis and some with severe liver or kidney impairment should not take this medication. Patients with certain genetic metabolic disorders should also refrain from administration. Patients at risk for urinary retention or with obstructive gastrointestinal conditions should use this medication cautiously. Dosage adjustment is required for patients with moderate to severe renal and hepatic dysfunction. Caution is also needed when used in conjunction with strong CYP3A4 inhibitors, and patients with certain gastrointestinal diseases or autonomic neuropathy require careful administration. When taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur. Especially dry mouth and constipation are common and may occur more frequently at higher doses. Serious gastrointestinal-related side effects, such as fecal impaction or intestinal obstruction, have been rarely reported; if symptoms are severe, immediate consultation with healthcare professionals is necessary. This medication can also cause serious allergic reactions such as angioedema and anaphylaxis; if such symptoms occur, administration must be stopped immediately, and appropriate treatment sought. Care should be taken while driving or operating machinery due to the risk of drowsiness or blurred vision. Using this medication alongside other anticholinergic drugs may enhance effectiveness or exacerbate side effects. When used in conjunction with medications that increase gastrointestinal motility, effectiveness may be reduced. Additionally, this medication is metabolized by certain enzymes (CYP3A4) in the liver; therefore, co-administration with medications that inhibit this enzyme may increase the concentration of this medication, necessitating dosage adjustment. Safety during pregnancy has not been established; therefore, caution should be exercised when administered to pregnant women. Breastfeeding women are recommended to avoid use, as this medication may be excreted in breast milk. Safety and effectiveness in pediatric patients have not been confirmed; therefore, this medication should not be used in children. Overdose may result in symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision, requiring appropriate treatment and management. Prolonged use of this medication has been reported to not significantly increase the risk of genotoxicity or tumor occurrence; however, if abnormal symptoms arise while using this medication, immediate consultation with healthcare professionals is required.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance

Pale pink round film-coated tablet

Package unit

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