BESYPHENA Tablet 5mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken with or without food and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dosage 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), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), use with caution and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent 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 or serious gastrointestinal diseases such as toxic megacolon. It should also not be administered to patients with myasthenia gravis, narrow-angle glaucoma, or allergies to this drug or its components. Patients undergoing dialysis or those with severe liver or kidney impairment who are taking strong CYP3A4 inhibitors should also avoid this medication. Patients with genetic galactose intolerance or lactase deficiency should not take this drug. Caution is required when administering to patients at risk of urinary retention, bladder outlet obstruction, gastrointestinal obstructive diseases, and reduced gastrointestinal motility. Patients with severe renal impairment or moderate liver impairment should have their maximum daily dose limited, and caution is advisable when co-administering with strong CYP3A4 inhibitors. Patients taking medications that could exacerbate gastroesophageal reflux disease or esophagitis and those with autonomic neuropathy should also use this medication with caution. This drug may cause side effects such as dry mouth, constipation, blurred vision, urinary retention, dryness of the eyes, and others. Especially, serious gastrointestinal side effects may occur with high doses, so caution is necessary. Stopping medication often occurs primarily due to dry mouth. Patients with heart-related diseases or at risk of QT prolongation or hyperkalemia should be cautious due to the potential for cardiac arrhythmias from this medication. If serious allergic reactions such as angioedema or anaphylaxis occur, the medication should be discontinued immediately, and appropriate treatment should be administered. Women who are pregnant should exercise caution as the safety of this medication has not been established, and nursing mothers should avoid it due to the possibility of transmission through breast milk. The safety and efficacy in children have not been confirmed, so this drug should not be used in pediatric patients. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may appear, and appropriate specialized treatment is necessary if severe symptoms occur. This drug may enhance the effects or worsen side effects when taken with other anticholinergic medications, so caution is advised. It may also reduce the effectiveness of medications that promote gastrointestinal motility, so a consultation with a healthcare provider is required when co-administering. Since this medication is metabolized by a specific enzyme (CYP3A4) in the liver, taking it with medications that strongly inhibit this enzyme may increase drug concentration, necessitating dosage adjustments. Conversely, caution is also required when co-administering with drugs that induce this enzyme as it may reduce drug effectiveness.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

This medication should be stored in a tightly closed container to prevent air and moisture exposure, and it's recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP×10)