OAB Tablet 5 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 drug 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 receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor: 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 urinary retention symptoms or severe gastrointestinal disorders. Additionally, it is not safe for patients with myasthenia gravis or narrow-angle glaucoma. Patients with allergic reactions to this drug and those undergoing hemodialysis or with severe liver impairment should also avoid this medication. Caution is necessary for patients with severe renal impairment or moderate liver impairment who are taking strong CYP3A4 inhibitors. Use with caution in patients with a risk of urinary retention or gastrointestinal obstructive diseases, or who are at risk of decreased gastrointestinal motility. Patients with severe renal or liver impairment should be careful not to exceed the maximum dose. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly, dry mouth and constipation tend to occur more frequently at higher doses. Severe gastrointestinal adverse reactions have been reported rarely, so if any unusual symptoms occur during treatment, immediate consultation with a healthcare professional is necessary. This medication may cause drowsiness or blurred vision, so caution should be taken when driving or operating machinery. Serious allergic reactions such as angioedema or anaphylaxis may occur; if symptoms arise, discontinue use immediately and seek treatment. When taken with other anticholinergic medications, the effects may be increased or side effects may worsen, so caution is advised when combining medications. Since this medication is metabolized in the liver, dose adjustments are necessary when taken with CYP3A4 inhibitors or inducers. The safety of this medication for pregnant women has not been established, so it should be used with caution if necessary, and breastfeeding women are advised to avoid using it. Safety and efficacy have not been confirmed for pediatric patients, so it should not be used in children. In case of overdose, appropriate treatment is required based on symptoms, especially with careful management of central nervous system symptoms or heart problems.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• indigestion
• epigastric pain
• vomiting
• urinary tract infection

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle