Vesigard 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 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 dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required when administering to patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Caution is required when administering to patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 3. Patients receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medicine should not be used by patients with urinary retention who cannot properly pass urine. Patients suffering from serious gastrointestinal diseases such as toxic megacolon should not take this medicine. This medicine is not suitable for patients with a disease causing muscle weakness called myasthenia gravis. Patients with narrow-angle glaucoma, which increases eye pressure, should also avoid this medication. Patients with allergic reactions to this medicine or its ingredients should refrain from using it. The use of this medicine is not recommended for patients undergoing hemodialysis. Patients with severe liver dysfunction should not be administered this medicine. Patients with severely diminished kidney function or those taking strong CYP3A4 inhibitors among those with moderate to severe liver dysfunction should not use this medication. This medicine contains lactose monohydrate, and should not be given to patients with genetic diseases that prevent the proper breakdown of sugars like lactose or galactose. Caution should be taken when administering this drug to patients at high risk of urinary retention due to bladder outlet obstruction or gastrointestinal obstruction, or patients at risk of decreased gastrointestinal motility. Patients with severely reduced kidney function, moderate liver dysfunction, and those taking strong CYP3A4 inhibitors should use this medicine with caution. Patients taking medications that may worsen gastroesophageal reflux or esophagitis, as well as patients with autonomic neuropathy should also use this medication with caution. This medication may cause dry mouth and constipation, and symptoms such as blurred vision or difficulty urinating may occur. Reported side effects include dry mouth, constipation, indigestion, dizziness, dry eyes, and urinary difficulty. In severe cases, serious side effects such as intestinal obstruction, angioedema, allergic reactions, liver dysfunction, and cardiac arrhythmias may occur, so caution is necessary. It may take about 4 weeks for this medicine to show its efficacy, so it should be taken consistently. Caution is advised while driving or operating machinery due to the risk of accidents from drowsiness or blurred vision. Combining this medication with other anticholinergic medications may enhance efficacy or worsen side effects, and consultation with a healthcare professional is recommended. As this medicine is metabolized in the liver, dose adjustment is necessary in patients with liver function impairment or those taking CYP3A4 inhibitors. Pregnant women should consult a doctor before taking this medicine as its safety has not been established. Breastfeeding women should avoid using this medicine as it may be secreted in breast milk and affect the newborn. Safety and efficacy for children have not been established, so it should not be administered to minors. In case of overdose, do not induce vomiting and use activated charcoal; appropriate treatment should be obtained if necessary. Patients with heart disease or those at risk of QT prolongation should be especially cautious as overdose may result in cardiac arrhythmias.

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

This medicine should be stored in a tightly closed container to avoid exposure to air or moisture. It is best stored at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)