Vesicaren 5.33 mg (Solifenacin Tartaric Acid)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5.33mg (equivalent to 5mg of solifenacin succinate) once daily. If needed, the dose may be increased to a maximum of 10.66mg (equivalent to 10mg of solifenacin succinate) once daily. This medicine may be taken with or without food and should be swallowed whole with water. 1. Patients with renal impairment No dose 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 5.33mg (equivalent to 5mg of solifenacin succinate) once daily. 2. Patients with hepatic impairment No dose 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 5.33mg (equivalent to 5mg of solifenacin succinate) 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 5.33mg (equivalent to 5mg of solifenacin succinate).

This medication should not be used in patients with urinary retention symptoms, severe gastrointestinal problems, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should be avoided in those allergic to this medication or its components, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction. Caution is advised when used in patients with bladder outlet obstruction, gastrointestinal obstruction, or decreased motility. Patients with moderate to severe renal or hepatic impairment may require dose adjustments, and care should be taken when using certain medications concurrently. While taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur. Notably, dry mouth and constipation relatively frequently occur, and the incidence of side effects may increase with high-dose administration. Serious gastrointestinal adverse reactions have been rarely reported; if any unusual symptoms occur during use, immediate consultation with a healthcare provider is necessary. This medication can cause severe allergic reactions like angioedema or anaphylaxis; if these symptoms appear, administration should be immediately discontinued and treatment sought. Caution is needed when driving or operating machinery due to the risk of drowsiness or blurred vision. This medication may increase effects or intensify side effects when used with other anticholinergic drugs, so caution is warranted. Moreover, it may interact with certain medications, altering its blood concentration; patients should inform healthcare providers of any concurrent medications. Safety in pregnant or breastfeeding women has not been established, so use should be avoided. Safety in pediatric patients has also not been confirmed, so it should not be administered to children. In cases of overdose, appropriate treatment is required, and in severe instances, professional emergency care may be necessary. No genotoxicity or tumorigenic risk has been reported with long-term use of this medication. Always consult with a healthcare provider before taking this medication, sufficiently informing them of your health status and any medications you are taking.

• 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 exposure to air and moisture. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius to maintain the medication's efficacy.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3], 100 tablets/box [10 tablets/PTP X 10]