Solifenacin Tablets 10 mg (Solifenacin 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 required 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 required 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This drug should not be used in patients with urinary retention, severe gastrointestinal disease, myasthenia gravis, or glaucoma. It should also not be administered to patients with hypersensitivity to this drug, those undergoing hemodialysis, or those with severe liver or kidney impairment. This medication contains lactose and is not suitable for patients with lactose intolerance or related genetic diseases. It should be used cautiously in patients at risk of urinary retention or with obstructive gastrointestinal disease or reduced gastrointestinal motility. Patients with severe kidney or liver impairment should have their dose limited, and caution is needed when used in combination with certain strong medications. Dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur as side effects during treatment, so symptoms should be monitored carefully. If serious side effects occur, treatment should be stopped immediately and medical consultation should be sought. This drug requires caution when driving or operating machinery due to the risk of drowsiness or blurred vision. When used in combination with other anticholinergic medications, the effect may be enhanced, or side effects may increase, so consultation with a professional is advised. Caution is required for use in pregnant or nursing women, and it is advisable to avoid use during breastfeeding. Safety and efficacy in children have not been established, and it should not be used in pediatric patients. In case of overdose, immediate medical attention is needed, and appropriate treatment should be provided depending on the symptoms. This medication also requires special caution in patients with heart disease or those at risk for QT prolongation.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)