Urotera Tablets 5 mg (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. Swallow it whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dosage 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 dosage 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 medication is used to control bladder hyperactivity. It should not be used in patients with certain conditions, such as urinary retention symptoms, severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. Patients undergoing hemodialysis or those with severe liver or kidney dysfunction should also avoid this medication. It should not be administered to patients with genetic lactose intolerance or similar issues. Caution is advised for patients at risk of urinary retention, those with gastrointestinal obstructive diseases, or autonomic neuropathy, and the maximum daily dosage should be limited for patients with moderate to severe renal or hepatic impairment. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with dry mouth and constipation being the most frequent. Rarely, serious allergic reactions such as angioedema or anaphylaxis may occur, and if these symptoms manifest, discontinue the medication immediately and seek treatment. Warning: This medication may impair driving or operation of machinery as it can cause drowsiness or fatigue. Care is needed when using it together with other anticholinergic medications as it may enhance effects or increase side effects. Furthermore, concomitant use with strong CYP3A4 inhibitors may increase drug concentration, necessitating dosage adjustments. Pregnant women or breastfeeding mothers should consult a physician before use, and it is not recommended for pediatric use due to unconfirmed safety and effectiveness. In case of overdose, symptoms like headache, dizziness, drowsiness, and blurred vision may occur; if this happens, seek medical attention immediately.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioneurotic edema
• nausea

Store this medication in a tightly closed container to prevent air or moisture ingress, and maintain at room temperature between 1 and 30 degrees Celsius. This storage method will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP×10], 30 tablets/bottle, 100 tablets/bottle