Solifenacin Tablets 5 mg (Solifenacin Succinate)

Adult dose

The recommended dose for adults (including the elderly) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken without regard to meals and should be swallowed whole with water. Dosage 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). Use 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 for patients with mild hepatic impairment. Use 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 administered to patients with urinary retention, severe gastrointestinal disorders, myasthenia gravis, narrow-angle glaucoma, allergies to this drug or its components, patients undergoing hemodialysis, severe liver impairment, or severe kidney impairment. In addition, caution is advised in patients with a risk of urinary retention or gastrointestinal obstruction, those with reduced gastrointestinal motility, moderate liver impairment, or strong CYP3A4 inhibitors. Common side effects include dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc., so caution is warranted. In severe cases, serious adverse reactions such as intestinal obstruction or angioedema may occur, and immediate medical attention should be sought if symptoms appear. Patients with risk factors for cardiac issues such as QT interval prolongation or hyperkalemia should be cautious as cardiac arrhythmias may occur. If serious allergic reactions such as angioedema or anaphylaxis occur during use of this medication, discontinue immediately and seek treatment. Be cautious when driving or operating machinery, as symptoms like blurred vision, drowsiness, and fatigue may occur. This medication may have enhanced effects or aggravated side effects when used with other anticholinergic drugs, so caution is needed when coadministering. Taking this drug with strong CYP3A4 inhibitors may increase its blood levels, raising the risk of side effects, necessitating dose adjustment. Safety during pregnancy has not been established, requiring special caution, and during breastfeeding, this drug may be excreted in breast milk and harm newborns, so use should be avoided. Safety and efficacy in pediatric patients have not been confirmed, and it should not be used in children. In cases of overdose, central nervous system symptoms, blurred vision, dizziness may occur, and appropriate emergency measures may be needed. Before taking this medication, consult healthcare providers about any heart conditions, kidney and liver function status, or 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 closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to preserve the medication's efficacy and safety for an extended period.

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP x 10)], 30 tablets/bottle, 100 tablets/bottle