Vesicalin Tablets 5mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. Dosage adjustment is necessary for the following patients. 1. Patients with renal impairment No dosage 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 dosage 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 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 where urination is difficult. Patients with severe gastrointestinal issues, severe myasthenia gravis, or narrow-angle glaucoma should also avoid this medication. It should not be administered to patients who are allergic to this medication or its components, those undergoing hemodialysis, or patients with severe liver or kidney dysfunction. This medication is also not suitable for patients with certain genetic metabolic issues. Caution is advised in patients at risk of urinary retention or those with gastrointestinal obstruction or reduced gastrointestinal motility. For patients with severe renal impairment, moderate liver impairment, or those taking certain strong medications, dosage adjustment may be necessary. Additionally, patients with gastroesophageal reflux, hernias, or autonomic neuropathy should use this medication carefully. Taking this medication may cause side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, nausea, dyspepsia, upper abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, leg edema, fatigue, cough, hypertension, dysuria, decreased urinary flow, bladder fullness, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, renal impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, and electrocardiogram abnormalities. Serious allergic reactions such as angioedema or anaphylaxis can occur, so if unusual symptoms appear, immediate consultation with a doctor is advised. There is a risk of cardiac side effects such as QT interval prolongation, so patients with a history of heart disease should be particularly careful. Caution is needed when driving or operating machinery due to the risk of drowsiness or blurred vision leading to accidents. This medication is metabolized by certain liver enzymatic pathways, so taking it with other medications that inhibit or induce these enzymes may change drug concentrations. Caution should be exercised in patients taking strong CYP3A4 inhibitors like ketoconazole, and it is advised to avoid concurrent use in patients with severe renal or liver function impairment. Pregnant or breastfeeding women should be cautious when using this medication due to insufficient safety information, and consultation with a doctor is necessary. Safety and efficacy in pediatric patients have not been established, so use is not recommended. In case of overdose, central nervous system symptoms, blurred vision, drowsiness, and headaches may occur, and appropriate medical attention should be sought. This medication is known not to affect tumor development or reproductive ability even after long-term use, but instructions from a healthcare professional should always be followed during use.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is best to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP)×10]