Syscare Tablet 5 mg (solifenacin succinate)

Adult dose

For adults (including elderly patients), the recommended dose is 5mg once daily. If needed, 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. Dose 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). For 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 dose adjustment is necessary for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors: 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 symptoms, severe gastrointestinal disorders, myasthenia gravis, or narrow-angle glaucoma. Patients with an allergy to this medication or its ingredients, those on hemodialysis, or those with severe liver or kidney impairment should not receive this medication. Caution should be taken when administering to patients at risk of urinary retention or those with gastrointestinal obstructive diseases or decreased gastrointestinal motility. Patients with severe kidney impairment or moderate liver impairment should have their dosage limited, and caution is needed when used in combination with strong CYP3A4 inhibitors. Possible side effects when taking this medication may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, particularly at high doses severe gastrointestinal side effects may occur. In case of serious allergic reactions such as angioedema or anaphylaxis, the medication should be stopped immediately, and appropriate treatment should be sought. There may be blurred vision, drowsiness, and fatigue when driving or operating machinery, so caution is advised. This medication may have increased effectiveness or intensified side effects when taken with other anticholinergic drugs. Care should be taken when used in combination. When taken with strong CYP3A4 inhibitors, the concentration of this medication in the blood may increase requiring dose adjustments. The safety during pregnancy has not been established, so it should be used with caution. Nursing mothers are advised to avoid this medication. The safety and efficacy in children have not yet been established, so it should not be used in pediatric patients. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and in such cases, activated charcoal administration along with appropriate emergency treatment should be pursued. Patients with a history of heart disease or at risk of QT prolongation should be particularly cautious as serious side effects may occur in the event of overdose.

• 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 sealed container to protect it from air and moisture. It is best to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

10 tablets/box [100 tablets (10 tablets/PTPX10)]