Vesicaver Tablet 5 mg (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 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 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 receiving a potent cytochrome P450 3A4 (CYP3A4) inhibitor 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 severe gastrointestinal diseases such as toxic megacolon. Patients with myasthenia gravis, angle-closure glaucoma, and those allergic to this medication or its components should also avoid taking it. Patients undergoing hemodialysis or with severe liver or kidney dysfunction should avoid this medication as well. Moreover, it should not be administered to patients with certain genetic issues. Patients at risk of urinary retention, bladder outlet obstruction, gastrointestinal obstructive diseases, or decreased gastrointestinal motility should use this medication cautiously. Patients with moderate to severe impairment of renal or hepatic function should be careful not to exceed the maximum dose per day, and dose adjustments are necessary when combined with strong CYP3A4 inhibitors. Patients taking medications that may cause or exacerbate gastroesophageal reflux disease or esophagitis, as well as those with autonomic neuropathy, should exercise caution. Dry mouth, constipation, blurred vision, urinary retention, and dry eyes are common side effects of this medication, and the occurrence of these symptoms may increase with higher doses. In severe cases, significant gastrointestinal adverse reactions such as fecal impaction or intestinal obstruction may occur. While taking this medication, severe allergic reactions such as angioedema or anaphylaxis may occur, so if these symptoms appear, discontinue immediately and seek appropriate treatment. There may be blurred vision, drowsiness, or fatigue when driving or operating machinery, so caution is necessary. This medication may enhance effects or exacerbate side effects when taken with other anticholinergic agents; therefore, caution is advised in combination therapy. Also, taking it with strong CYP3A4 inhibitors may increase drug concentration, requiring dose adjustments. The safety of this medication during pregnancy has not been established; thus, careful consideration is needed if taken by pregnant women. Breastfeeding women are advised to avoid this medication as it may be excreted in breast milk. Safety and efficacy in pediatric patients have not been established, so it should not be used in children. In case of overdose, central nervous system symptoms or cardiovascular abnormalities may occur, and immediate medical attention should be sought for appropriate treatment. This medication has been reported to pose no risk of genotoxicity or tumor formation and is known to have no significant impact on reproductive ability or fetal development.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• vascular-neurogenic edema
• nausea

This medication should be kept in a tightly sealed container to protect it from air and moisture. Furthermore, it is advisable to store the medication at room temperature between 1°C and 30°C. It is safe to avoid very hot or very cold places.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP × 10]