Solifenacin Tablets 10 mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), 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 in patients with urinary retention symptoms or serious gastrointestinal issues such as toxic megacolon, patients with myasthenia gravis, patients with angle-closure glaucoma, and patients allergic to this drug or its ingredients. Additionally, it should not be administered to patients undergoing hemodialysis, those with severe liver impairment, severe renal impairment, or certain genetic conditions. Caution should be exercised when prescribing this medication to patients at risk for urinary retention, gastrointestinal obstructive disease, those at risk for decreased gastrointestinal motility, patients with severe renal impairment or moderate liver impairment, or when used in conjunction with potent CYP3A4 inhibitors. Patients with heat exhaustion, gastroesophageal reflux disease, and autonomic neuropathy should also be given cautious consideration. Side effects when taking this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with dry mouth and constipation being particularly common. Severe gastrointestinal adverse reactions such as fecal impaction, colonic obstruction, and intestinal obstruction have been reported, so if symptoms are severe, consult a physician immediately. Patients with a risk of QT prolongation syndrome or hyperkalemia may experience cardiac arrhythmias, so caution is needed for those with heart-related issues. Serious allergic reactions such as angioedema or anaphylaxis may occur, so if symptoms appear, discontinue use immediately and seek treatment. During the use of this medication, caution may be necessary for driving or operating machinery, as drowsiness, blurred vision, or fatigue may occur. This medication may enhance the effects or side effects when used with other anticholinergic medications, so consultation with a physician is recommended. It may also reduce the effectiveness of medications that increase gastrointestinal motility. Co-administration with potent CYP3A4 inhibitors may increase the blood concentration of this medication, requiring dosage adjustments, and patients with severe renal or liver impairment should avoid such combinations. The safety of this medication during pregnancy has not been established, so pregnant women should consult a physician before use, and breastfeeding women are advised to avoid this medication. The safety and efficacy in pediatric patients have not been established, so it should not be used in children. In the case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and in severe cases, professional treatment may be required. This medication has been reported to not increase the risk of tumor formation even with long-term use, and it has been confirmed not to affect fertility or embryonic development.

• 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 or moisture from entering. It is important to maintain a storage temperature of room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a longer period.

Appearance

Pale pink, round film-coated tablet

Package unit

100 tablets (10 tablets/PTP × 10)