Solveshin Tablets 10 mg (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 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 dosage 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 taking strong cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking 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 urinary retention symptoms or severe gastrointestinal conditions. Patients with myasthenia gravis or angle-closure glaucoma should also not receive this medication. Patients who are allergic to this medication or its components, patients undergoing hemodialysis, patients with severe liver impairment or severe kidney impairment should also not use this medication. In addition, it should not be administered to patients with certain genetic metabolic disorders. Caution is advised when administering to patients with bladder outlet obstruction or gastrointestinal obstructive diseases who have a risk of urinary retention, as well as to patients at risk for decreased gastrointestinal motility. Dose adjustment is necessary for patients with severe kidney impairment, moderate liver impairment, or those taking strong CYP3A4 inhibitors. Patients with gastroesophageal reflux disease or those taking certain medications, as well as those with autonomic neuropathy should also be monitored closely. Common side effects of this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Especially at a dose of 10 mg, these side effects have been reported more frequently. In severe cases, serious adverse reactions such as intestinal obstruction or angioedema may occur. This medication may cause heart-related side effects such as QT interval prolongation and polymorphic ventricular tachycardia, so patients with heart disease should use caution. If allergic reactions such as angioedema or anaphylaxis occur, administration should be discontinued immediately, and treatment should be sought. Drowsiness, blurred vision, and fatigue may occur when driving or operating machinery, so caution is needed. Using this medication with other anticholinergic drugs may enhance effects or worsen side effects. Additionally, it may reduce the effects of medications that increase gastrointestinal motility. This medication is metabolized in the liver; therefore, when used with strong CYP3A4 inhibitors, the dose should be reduced, and it is advisable to avoid co-administration in patients with severe kidney or liver impairment. The safety of this medication in pregnant women has not been established, so pregnant women should use it with caution, and lactating women should avoid using this medication as it may be excreted in breast milk and harm the newborn. Safety in children has not been confirmed, so it should not be administered to pediatric patients. In cases of overdose, central nervous system symptoms, blurred vision, and dizziness may occur, and activated charcoal administration and appropriate treatment may be necessary. This medication has not been reported to pose a risk of genotoxicity or tumorigenesis with long-term use.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is also best to store the medication at room temperature between 1 and 30 degrees Celsius. This storage condition helps maintain the effectiveness of the medication for a longer period.

Appearance

Pale pink round film-coated tablets

Package unit

100 tablets/PTP