Beskan Tablet 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. The dosage regimen must be adjusted 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). 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 dose adjustment is necessary in 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 a strong cytochrome P450 3A4(CYP3A4) inhibitor 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 and difficulty urinating. It is also advisable not to administer to patients with severe gastrointestinal issues or conditions like toxic megacolon. Patients with myasthenia gravis, a condition that causes muscle weakness, and those with angle-closure glaucoma, characterized by high intraocular pressure, should not use this medication. It must not be given to patients who have allergic reactions to this drug or its ingredients. Patients undergoing dialysis, those with severe liver dysfunction, and those with greatly impaired kidney function or moderate liver dysfunction taking strong CYP3A4 inhibitors should also avoid this medication. Moreover, patients with genetic disorders such as galactose intolerance, hereditary lactase deficiency, or glucose-galactose malabsorption should not receive this treatment. Caution is needed when administering to patients at risk of urinary retention or those with obstructed bladder outlets, patients with gastrointestinal obstruction, or those at risk of decreased gastrointestinal motility. Patients with severe renal impairment or moderate hepatic impairment should have their dosage limited, and special caution is required when taking this medication concomitantly with strong CYP3A4 inhibitors. Patients taking medications that may worsen gastroesophageal reflux disease or esophagitis, and those with autonomic neuropathy should also be carefully administered this drug. This medication may cause various side effects, including dry mouth, constipation, blurred vision, difficulty urinating, and dry eyes. In particular, dry mouth and constipation are the most commonly reported side effects, and caution is required as severe gastrointestinal issues can arise with high-dose usage. This medication may pose risks when driving or operating machinery due to drowsiness or blurred vision. When taken with other anticholinergic medications, effects may be amplified or unwanted side effects may occur, and consultation with a physician is advised. Since this drug is metabolized in the liver, dosage adjustments are needed when taken in combination with medications that inhibit specific liver enzymes (CYP3A4). The safety of this drug during pregnancy has not been established; thus, it should be used with caution. It is advisable to avoid use during breastfeeding as this medication may be transferred to breast milk. The safety and efficacy of this drug have not been confirmed in children, and it should not be administered to them. In cases of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, with severe instances possibly requiring professional treatment. Patients with heart disease or electrolyte abnormalities while taking this medication should be cautious due to the risk of heart-related side effects such as QT prolongation. If severe allergic reactions, such as angioedema or anaphylaxis, occur, the medication should be discontinued immediately and appropriate treatment sought.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the efficacy and prevent deterioration of the drug.

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets/PTP [(10 tablets/PTP × 10)], 100 tablets/bottle