Solvese Tablet 5 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. Dosage adjustment is required for the following patients. 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 certain patients. For example, those with urinary retention, severe gastrointestinal disorders, myasthenia gravis, severe glaucoma, allergy to this medication or its ingredients, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction should not receive this drug. This medication should also be used cautiously in some patients. Patients at risk for urinary retention or suspected gastrointestinal obstruction, those at risk for decreased gastrointestinal motility, patients with moderate to severe renal or hepatic impairment, patients taking certain potent medications, those with gastroesophageal reflux disease or esophagitis, and patients with autonomic nervous system disorders should be administered this medication under medical supervision. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes when taking this medication. At high doses, serious side effects such as gastrointestinal obstruction may occur, so caution is needed. Furthermore, this drug may pose a risk of inducing cardiac rhythm abnormalities; patients with heart diseases or electrolyte imbalances should exercise caution. If vascular edema or allergic reactions occur, medication should be stopped immediately and appropriate medical treatment should be sought. This medication may cause drowsiness, blurred vision, and fatigue when driving or operating machinery, so care should be taken. Using it with other anticholinergic medications can increase its effectiveness or worsen side effects, and may reduce the effectiveness of certain gastrointestinal motility agents. Since this drug is metabolized by specific enzymes in the liver, co-administration with medications that strongly inhibit these enzymes can increase drug concentration, necessitating dosage adjustments. Safety during pregnancy has not been established, so careful use is advised; during breastfeeding, this medication may be excreted into breast milk and affect the infant, thus usage should be avoided. Safety in children has also not been established, so it should not be administered to children. In the case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may appear, and gastric lavage or detoxification treatment should be performed as necessary. There have been no reports of genotoxicity or tumorigenesis with long-term use of this medication. Therefore, when using this medication, take it according to the physician's instructions for the correct dosage and method, and consult healthcare providers immediately if abnormal symptoms occur.

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

This medication may be sensitive to air and moisture, therefore it should be stored in a tightly sealed container. Additionally, it is recommended to store the medication at room temperature, between 1°C and 30°C, avoiding extremes of temperature.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/PTP