Solifenacin 5mg Tablet (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) 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. 1. Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should 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 issues like toxic megacolon, myasthenia gravis, or narrow-angle glaucoma. It is also contraindicated in patients with a known allergy to this medication or its ingredients, patients undergoing dialysis, patients with severe liver disease, and those with severe kidney disease or moderate liver disease who are taking strong CYP3A4 inhibitors. Patients with genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use this medication. Patients at risk of urinary retention or with significant bladder outlet obstruction, with obstructive gastrointestinal diseases, or at risk of decreased gastrointestinal motility, as well as those with severe kidney disease (creatinine clearance ≤30 ml/min), moderate liver disease (Child-Pugh class B), and patients using strong CYP3A4 inhibitors should use this medication with caution. Additionally, caution is required in patients with gastroesophageal reflux disease or those taking medications that could exacerbate esophagitis, as well as patients with autonomic neuropathy. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur, particularly at the 10mg dose, where they are more common. In severe cases, gastrointestinal serious adverse reactions like fecal impaction or intestinal obstruction may arise, requiring vigilance. This medication can cause heart rhythm issues such as QT interval prolongation, so patients with a risk of QT prolongation or hyperkalemia should be particularly cautious. Serious allergic reactions such as angioedema or anaphylaxis may occur, and if these symptoms appear, the medication should be stopped immediately, and treatment should be sought. Drowsiness, blurred vision, and fatigue may occur while driving or operating machinery, so caution is advised. The effectiveness of this medication may be increased or side effects may become more severe when used with other anticholinergic medications, and it may reduce the effectiveness of medications that increase gastrointestinal motility. As this medication is metabolized by the CYP3A4 enzyme, co-administration with strong CYP3A4 inhibitors may increase drug concentration and the risk of side effects. Therefore, the maximum dosage of this medication should be limited in such cases. Safety during pregnancy has not been established, so caution is needed for pregnant women, and breastfeeding women should avoid this medication due to the possibility of excretion in breast milk. Safety and efficacy in pediatric patients have not been confirmed, so this medication should not be administered to children. In the case of overdose, symptoms such as headache, thirst, dizziness, drowsiness, and blurred vision may occur, and treatment such as activated charcoal administration or gastric lavage may be necessary. Patients with a history of heart disease or risk of QT prolongation require special caution in case of overdose.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is also recommended to store the medication at room temperature, which is between 1 and 30 degrees Celsius, avoiding extremes of hot or cold.

Appearance

Bright yellow, round film-coated tablet

Package unit

100 tablets (10 tablets/PTP X 10)