Yutocare Tablets 5mg (Solifenacin Succinate)

Adult dose

In adults (including the elderly), the recommended dose 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 necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong 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, severe gastrointestinal disorders, myasthenia gravis, or narrow-angle glaucoma. Patients who are allergic to this medication or its components, those undergoing hemodialysis, and patients with severe liver or kidney impairment should also avoid use. Caution is required in patients at risk of urinary retention or gastrointestinal obstruction and those at risk of decreased gastrointestinal motility. Patients with severe renal impairment or moderate hepatic impairment should have their dosage limited, and caution is needed when used with potent CYP3A4 inhibitors. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur. In particular, dry mouth and constipation can occur more frequently at higher doses. Severe side effects such as intestinal obstruction or angioneurotic edema may occur, so consultation with a doctor is necessary if symptoms are severe. Caution is required when driving or operating machinery, as drowsiness or fatigue may occur. When taken with other anticholinergic medications, the effects may be enhanced or side effects may increase, so caution is advised with concomitant medications. Additionally, co-administration with potent CYP3A4 inhibitors may increase the blood concentration of this medication, necessitating dose adjustment. The safety of this medication has not been established in pregnant women, so caution is needed. It is advisable for breastfeeding women to avoid this medication. The safety and efficacy in children have not been confirmed, so it should not be used. In case of overdose, immediate medical attention is required, and specialized treatment may be necessary for severe symptoms. Before administering this medication, check for heart disease, electrolyte imbalances, and other medications being taken.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablets

Package unit

[Domestic] 100 tablets (10 tablets/PTP x 10), [Export] 30 tablets (10 tablets/PTP x 3)