Solifenacin Tablets 10 mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken regardless of meals 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 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 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 5mg 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 5mg.

This drug should not be used in patients with urinary retention symptoms or severe gastrointestinal diseases, myasthenia gravis, and narrow-angle glaucoma. Patients with allergic reactions to this drug or its ingredients, patients on dialysis, and those with severe liver or kidney dysfunction should also avoid administration. Particularly, patients with moderate or worse liver or kidney dysfunction or those taking strong CYP3A4 inhibitors should use with caution and dose limitation may be necessary. Patients with certain conditions such as urinary obstruction, intestinal obstruction, and autonomic neuropathy should also be administered with caution. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, so symptoms should be closely monitored. Serious side effects such as intestinal obstruction or fecal impaction, angioedema, and anaphylactic reactions have been reported; if any abnormal symptoms occur, discontinue the medication immediately and consult a healthcare professional. This medication may increase the risk of accidents due to drowsiness or blurred vision during driving or operating machinery, so caution is advised. Additionally, if taken with other anticholinergic medications, effects or side effects may increase, so always consult a doctor or pharmacist when combining drugs. The safety of this medication has not been established in pregnant or breastfeeding women, so consultation with a specialist is essential prior to administration. For pediatric patients, safety and efficacy have not been confirmed, so it is advisable not to use it. In case of overdose, appropriate emergency treatment like administering activated charcoal is needed rather than inducing vomiting, and professional treatment is required for severe central nervous system symptoms or heart problems.

• 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 advisable to keep it at room temperature between 1 to 30 degrees.

Appearance

Bright pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP*10), 30 tablets/bottle, 100 tablets/bottle