Solifenacin Tablet 5mg (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. 1. Patients with renal impairment: No dosage adjustment is necessary in 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 necessary in 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

This medication should not be used in patients with urinary retention symptoms or severe gastrointestinal diseases such as toxic megacolon. Patients with myasthenia gravis or angle-closure glaucoma, as well as those allergic to this medication or its components, should also avoid this medication. It is contraindicated in patients undergoing hemodialysis or with severe liver or kidney impairment. Caution is needed for patients with moderate liver impairment taking strong CYP3A4 inhibitors. It should be administered cautiously to patients at risk of urinary retention or gastrointestinal obstructive disease, or those with decreased gastrointestinal motility. The maximum daily dose should be limited for patients with severe kidney impairment or moderate liver impairment, and dose adjustment is necessary when used with strong CYP3A4 inhibitors. Patients taking medications that may cause or worsen heat intolerance, gastroesophageal reflux disease, or esophagitis should also be cautious. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Serious adverse reactions such as gastrointestinal obstruction have been reported, particularly at high doses, making dose adjustment important. If there are symptoms of angioedema or anaphylactic reaction, administration should be stopped immediately, and appropriate treatment should be sought. This medication can cause drowsiness or blurred vision, so caution is needed when driving or operating machinery. The co-administration with anticholinergic medications may increase side effects and reduce the effects of medications that increase gastrointestinal motility. Since this medication is metabolized by the CYP3A4 enzyme, dose adjustments are necessary when used with strong CYP3A4 inhibitors. Its safety during pregnancy has not been established, so it should be used with caution; it is recommended to avoid use during breastfeeding. The safety and efficacy for children have not been confirmed, so it should not be administered to children. In case of overdose, appropriate emergency treatment such as gastric lavage and administration of activated charcoal is necessary, and professional treatment may be required for severe central nervous system symptoms or cardiac abnormalities.

• 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 protect it from air and moisture. It is best to store it at room temperature between 1°C and 30°C.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP*10)]