Solifenacin Tablet 10mg (Solifenacin Succinate)

Adult dosage

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 used in patients with urinary retention, severe gastrointestinal problems, myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to patients who have allergies to this drug or its components, patients undergoing hemodialysis, or those with severe liver or kidney dysfunction. Patients with certain genetic disorders such as congenital lactase deficiency or galactose intolerance should also avoid this medication. Patients with a risk of bladder outlet obstruction, gastrointestinal obstruction, or decreased gastrointestinal motility, as well as those with severe or moderate liver or kidney impairment, should use this drug cautiously. In particular, if taken with strong CYP3A4 inhibitors, dose adjustments may be necessary. Patients with gastroesophageal reflux disease or autonomic neuropathy should also exercise caution. Common side effects when taking this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Serious side effects, such as gastrointestinal obstruction, have been reported with high dosages. Patients with heart diseases, QT prolongation syndrome, or hyperkalemia are at risk for cardiac arrhythmias and should take precautions. If allergic reactions such as angioedema or anaphylaxis occur, the use of this drug should be discontinued immediately, and treatment should be sought. This drug may cause drowsiness, blurred vision, or fatigue when driving or operating machinery, necessitating caution. Using this medication together with other anticholinergic agents may enhance its effects or worsen side effects, and there may be interactions with medications that increase gastrointestinal motility. This drug is mainly metabolized by the CYP3A4 enzyme, thus, when used with strong CYP3A4 inhibitors, the drug concentration may increase, requiring dose modifications. The safety of this medication during pregnancy has not been established, so pregnant women should use it cautiously, and breastfeeding women should avoid its use. The safety and efficacy in children have not been confirmed, so it should not be administered to children. In case of overdose, central nervous system symptoms, blurred vision, or dizziness may occur, and appropriate measures such as gastric lavage or activated charcoal administration should be taken if necessary. Patients with heart diseases or risks of QT prolongation should be particularly cautious in cases of overdose.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Moreover, it should be kept away from extremely hot or cold places, ideally stored at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright pink round film-coated tablet

Package unit

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