Vesicare Tablets 10 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 given to patients with urinary retention, severe gastrointestinal problems, myasthenia gravis, glaucoma with high intraocular pressure, patients allergic to this medication or its ingredients, patients undergoing hemodialysis, or those with severe liver or kidney dysfunction. Use cautiously in patients at risk for urinary retention or gastrointestinal obstruction, patients with severe kidney or liver impairment, patients taking strong CYP3A4 inhibitors, certain gastrointestinal patients, and patients with autonomic neuropathy. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur with this medication, especially when taken at high doses where serious adverse reactions such as gastrointestinal obstruction could occur. Severe allergic reactions such as angioedema or anaphylaxis may appear, so if any symptoms occur, stop taking the medication immediately and seek medical assistance. This medication may cause drowsiness or blurred vision, which could be hazardous when driving or operating machinery, so caution is needed. Taking this medication with other anticholinergic drugs may increase effects or exacerbate side effects, and it may interact with medications that increase gastrointestinal motility. This medication is metabolized in the liver, and when taken with strong CYP3A4 inhibitors, the concentration may increase, raising the risk of side effects, thus requiring dosage adjustments. The safety of this medication has not been established in pregnant women, so it should be administered cautiously, and in lactating mothers, it should be avoided as it may be excreted in breast milk and could harm the infant. Safety and efficacy have not been confirmed in children, so it should not be used in pediatric populations. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and in severe cases, professional treatment might be necessary. Before taking this medication, it is important to check for cardiovascular risk factors such as heart disease, hypokalemia, or prolonged QT syndrome, and special caution is required for these patients.

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

This medication must be stored in a tightly closed container to protect it from air and moisture exposure. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright pink round film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 3), 100 tablets (10 tablets/PTP × 10)