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 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 dose adjustment is required for 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 dose adjustment is required for 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors In patients receiving ketoconazole or another potent 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 or severe gastrointestinal disorders such as toxic megacolon, patients with myasthenia gravis, narrow-angle glaucoma patients, and patients allergic to this drug or its components. Additionally, patients on hemodialysis, those with severe liver or kidney dysfunction, and patients with certain genetic metabolic disorders should not take this medication. Caution is required for patients at risk of urinary retention or those with gastrointestinal obstructive disorders, decreased gastrointestinal motility, and patients with severe kidney or liver dysfunction, as dosage adjustments may be necessary. This medication can commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. In particular, dry mouth and constipation may occur more frequently at higher doses. Severe side effects such as fecal impaction, colonic obstruction, and intestinal obstruction have been reported, and if allergic reactions such as angioedema or anaphylaxis occur, the medication must be discontinued immediately and treated. This medication may cause drowsiness or blurred vision when driving or operating machinery, so caution is advised. Moreover, caution should be exercised when used in conjunction with other anticholinergic medications, as this can increase the effect or severity of side effects. This medication is metabolized in the liver by certain enzymes (CYP3A4), so taking it with drugs that strongly inhibit this enzyme may increase drug concentration, heightening the risk of side effects. The safety of this medication during pregnancy has not been established, so careful use is necessary, and breastfeeding women are advised to avoid using this drug. Safety and efficacy in children have not been confirmed, so it should not be used in this population. In cases of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and appropriate emergency treatment may be required.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to maintain a room temperature between 1°C and 30°C when storing the medicine. This helps maintain its efficacy and ensures safe use.

Appearance

Light pink round film-coated tablets

Package unit

10 tablets (PTP) x 10