Besisol Tablets 5 mg (Solifenacin Succinate)

Adult dose

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 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 dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor: In 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 diseases such as toxic megacolon. It is also contraindicated in patients with myasthenia gravis, narrow-angle glaucoma, and in those who have hypersensitivity to this medication or its components. Patients undergoing hemodialysis and those with severe liver dysfunction (Child-Pugh grade C), as well as those with severe kidney impairment and moderate liver impairment taking strong CYP3A4 inhibitors should not use this medication. Patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption are also not candidates for this medication. Caution should be exercised when administering this drug to patients with a risk of urinary retention or those with pronounced bladder outlet obstruction, patients with gastrointestinal obstructive diseases, and patients at risk of gastrointestinal motility reduction. Patients with severe renal impairment (creatinine clearance ≤30 ml/min) and moderate liver impairment (Child-Pugh grade B) should have their maximum daily dose limited to 5 mg. Patients who are on strong CYP3A4 inhibitors, have a history of hernias, gastroesophageal reflux disease, or autonomic neuropathy should also be cautious. This medication can commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and eye dryness. In particular, dry mouth and constipation occur more frequently with higher doses. Rarely, serious adverse reactions such as angioedema or gastrointestinal obstruction have been reported, so if abnormal symptoms occur, immediate consultation with a healthcare professional is necessary. This medication may pose a risk of cardiac side effects in patients with QT prolongation syndrome or hyperkalemia, so caution is warranted. If angioedema or anaphylactic reactions occur, the drug should be discontinued immediately, and appropriate treatment should be received. Caution is required while driving or operating machinery, as symptoms such as drowsiness or blurred vision may impact performance. This medication may enhance the effects or worsen side effects when used with other anticholinergic drugs. It may also reduce the effectiveness of gastrointestinal motility-increasing medications, so caution is required when used together. Using it with strong CYP3A4 inhibitors may increase the plasma concentration of this medication, requiring dosage adjustments. The safety of this medication during pregnancy has not been established, so it should be administered cautiously to pregnant women, and its use should be avoided during breastfeeding. The safety and efficacy have not been confirmed in pediatric patients, so it should not be administered to them. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and activated charcoal or other appropriate treatments may be needed if necessary. Severe side effects should be reported to a healthcare professional immediately.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer period.

Appearance

Light yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP X 10)