Solifenacin 10mg Tablet (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. No dosage adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. No dosage adjustment is necessary in patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 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 or serious gastrointestinal diseases such as toxic megacolon. It should also be avoided in patients with myasthenia gravis or angle-closure glaucoma, and in those allergic to this medication or its components. Patients undergoing dialysis or those with severe liver or kidney impairment may also be at risk when using this medication. Caution is required for patients with moderate liver impairment taking strong CYP3A4 inhibitors. Patients with genetic galactose intolerance or lactose deficiency should also avoid this medication. This medication should be used cautiously in patients at risk of urinary retention or bladder outlet obstruction, those with gastrointestinal obstructions, or patients at risk of reduced gastrointestinal motility. Patients with severe renal impairment or moderate liver impairment should have their doses limited, and caution is needed when used in conjunction with strong CYP3A4 inhibitors. Caution is also advised in patients with gastroesophageal reflux disease or autonomic neuropathy when using this medication. Common side effects of this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. In particular, dry mouth and constipation tend to occur more frequently at higher doses. Rarely, serious side effects such as angioedema or severe gastrointestinal obstruction have been reported. This medication may cause cardiac rhythm disorders in patients at risk of heart problems such as QT prolongation syndrome or hyperkalemia. Serious allergic reactions such as angioedema or anaphylaxis may occur; if such symptoms arise, immediate discontinuation and treatment are necessary. Caution is required while driving or operating machinery, as symptoms such as drowsiness, fatigue, and blurred vision may occur rarely. Using this medication in conjunction with other anticholinergic drugs may enhance effects or increase side effects, therefore caution is required. It may also reduce the effects of medications that increase gastrointestinal motility. This medication is primarily metabolized by the CYP3A4 enzyme, so taking it with strong CYP3A4 inhibitors may increase its plasma concentration and elevate the risk of side effects. Therefore, doses should be reduced when using it with such drugs, and concurrent use should be avoided in patients with severe renal or liver impairment. The safety of this medication during pregnancy has not been established, so pregnant women should use it cautiously. Nursing women should avoid using this medication as it may be excreted in breast milk and could affect the newborn. The safety and efficacy of this medication in children have not been confirmed, so it should not be used in pediatric patients. Overdosage may result in symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision, requiring appropriate emergency treatment. If severe central nervous system symptoms, heart problems, or urinary retention occur, professional treatment is needed.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP × 10)