Solafenacin Tablets 5 mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults, including older adults, 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. The dosage must be adjusted for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild to 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 in 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 should not be used in patients with urinary retention, severe gastrointestinal conditions, myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to patients with hypersensitivity to this drug or its components, those on hemodialysis, or patients with severe liver or kidney impairment. It is also inappropriate for patients with genetic metabolic disorders such as lactose intolerance. Use with caution in patients at risk for urinary retention or with gastrointestinal obstructive disorders or risk of decreased gastrointestinal motility. Patients with severe renal impairment or moderate liver impairment should limit the maximum daily dosage, and caution is also needed when used with strong CYP3A4 inhibitors. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Serious gastrointestinal adverse reactions, angioedema, or anaphylaxis can occur, so if symptoms arise, immediate consultation with a healthcare provider is necessary. Patients with prolonged QT syndrome or hyperkalemia may be at risk for cardiac side effects and should exercise caution. There is an increased risk of accidents due to drowsiness or blurred vision when driving or operating machinery. This medication may enhance effects or worsen side effects when used with other anticholinergic drugs and can reduce the effects of drugs that increase gastrointestinal motility. Since it is metabolized by CYP3A4, dosage adjustment may be necessary when used with strong CYP3A4 inhibitors. The safety during pregnancy has not been established, so it should be used with caution, and breastfeeding mothers are advised to avoid its use. The safety and efficacy in children have not been confirmed, so it should not be used in that population. In case of overdose, administration of activated charcoal and appropriate treatment is necessary, and rapid intervention is required for severe central nervous system symptoms or cardiac side effects. Discuss thoroughly with healthcare professionals before using this medication to inform them about your health status and any medications you are taking.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• dyspepsia
• abdominal pain
• vomiting
• urinary tract infection

This medication should be stored in a sealed container to prevent air or moisture exposure. Avoid storing the medication in excessively hot or cold places; it is best stored at room temperature between 1°C and 30°C.

Appearance

Light yellow round film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP*10)]