Vesicare Tablets 10 mg (Solfenacin 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 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 a strong cytochrome P450 3A4(CYP3A4) inhibitor: For patients receiving 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 disorders, myasthenia gravis, narrow-angle glaucoma, and in patients who are allergic to this medication or its components. Patients undergoing hemodialysis, with severe hepatic or renal impairment, and those with certain genetic metabolic disorders should also avoid this medication. Administration should be cautious in patients at risk of urinary retention or with gastrointestinal obstruction, renal or hepatic function moderately impaired, those taking strong CYP3A4 inhibitors, and patients with gastroesophageal reflux disease or autonomic neuropathy. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, and particularly high doses may lead to serious adverse reactions like gastrointestinal obstruction. Severe allergic reactions, such as angioedema or anaphylaxis, have been reported; in such cases, administration must be stopped immediately, and appropriate treatment should be sought. Care should be taken when driving or operating machinery due to the risk of accidents from symptoms like blurred vision, drowsiness, and fatigue. The effects may be enhanced or side effects may worsen when taken with other anticholinergic medications, and it may reduce the effect of medications that increase gastrointestinal motility. Particularly, when combined with strong CYP3A4 inhibitors, the blood concentration of this medication may increase, necessitating dosage adjustments, and combination should be avoided in patients with severe liver or kidney impairment. Safety during pregnancy has not been established, caution is needed during use, and breastfeeding women should avoid using this medication. The safety and efficacy in pediatric patients have not been confirmed; hence, it should not be used in children. In case of overdose, central nervous system symptoms, cardiac effects, and urinary retention may occur, requiring immediate medical attention and appropriate detoxification measures. There is a low risk of genotoxicity or tumorigenesis with prolonged use of this medication, and no effects on reproductive ability have been reported.

• 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 protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets/box [10 tablets/PTPX10]