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 necessary for patients with mild or 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 for 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 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 symptoms of impaired urination. Patients with toxic megacolon or serious gastrointestinal disorders, severe myasthenia gravis, and glaucoma patients with high intraocular pressure should not take this medication. It should also be avoided by individuals allergic to this medication or its components, those undergoing hemodialysis, and patients with severe liver or kidney dysfunction. Additionally, patients with certain genetic metabolic disorders should not use this medication. Caution is required for patients at risk of impaired urination or with bladder outlet obstruction, gastrointestinal obstruction, and slow gastrointestinal motility. Patients with moderate kidney or liver function impairment should limit the dosage of this medication, and care should be taken when combined with certain medications. Patients taking medications that can cause or worsen problems in the stomach and esophagus, as well as those with issues in the autonomic nervous system, should also use caution. This medication can cause dry mouth and constipation, as well as blurred vision or dry eyes. Difficulties in urination may occur, so consult a doctor if these symptoms appear. In severe cases, gastrointestinal issues such as bowel obstruction or fecal impaction may arise, requiring caution. This medication may cause drowsiness or fatigue when driving or operating machinery, so caution is needed. The effects of this medication may be enhanced, or side effects may be intensified when combined with other anticholinergic drugs, so consult a physician when using in combination. It may also reduce the effects of certain gastrointestinal motility agents. Since this medication is metabolized by specific enzymes in the liver, co-administration with strong enzyme inhibitors can increase drug concentration and the risk of side effects. Therefore, dosage adjustment is necessary when used with strong enzyme inhibitors. The safety of this medication during pregnancy has not been established, so pregnant women should use it cautiously, and nursing mothers should avoid use as it may be transmitted in breast milk. The safety and efficacy of this medication have not been confirmed in children, and its use is not recommended. In the case of overdose, symptoms may include headache, dry mouth, dizziness, drowsiness, and blurred vision, and severe cases may require appropriate treatment. Before taking this medication, check for risk factors such as heart disease, hypokalemia, and QT prolongation syndrome, and if any symptoms of vascular edema or anaphylaxis occur, discontinue use immediately and seek treatment. During treatment, examinations for other causes of frequent urination are also necessary, and appropriate antibiotic treatment should be combined if a urinary tract infection is present.

• 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 closed container to prevent exposure to air or moisture at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness.

Appearance

Round film-coated tablets in bright pink color

Package unit

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