Vesicare 5 mg (Solifenacin Succinate)

Adult dose

The usual 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 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 drug is used to alleviate symptoms such as bladder overactivity or incontinence. This drug should not be used in certain patients. For example, it should not be administered to patients who have urinary retention symptoms or significant gastrointestinal diseases, those with severe myasthenia gravis, acute angle-closure glaucoma patients, those allergic to this drug or its components, patients undergoing hemodialysis, those with severe liver or kidney dysfunction, and patients with specific genetic metabolic disorders. Additionally, caution is required when administering to certain patients. Those at risk of urinary retention, bladder outlet obstruction, gastrointestinal obstructive diseases, those at risk of decreased gastrointestinal motility, patients with severe renal or liver impairment, patients taking strong CYP3A4 inhibitors, as well as patients with gastroesophageal reflux disease or esophagitis, and those with autonomic neuropathy should be carefully monitored. Common side effects while taking this drug may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Especially, dry mouth and constipation are common and the rate of side effects may increase with higher doses. Rarely, serious allergic reactions such as angioedema and anaphylaxis have been reported, and if such symptoms occur, discontinuation of the drug and treatment should be pursued immediately. This drug requires caution especially in activities like driving or operating machinery due to symptoms such as drowsiness or blurred vision. Interactions with other medications are also important. In particular, taking anticholinergic medications may enhance the effects or exacerbate side effects, and co-administration with strong CYP3A4 inhibitors may increase the blood concentration of this drug, requiring dose adjustment. The safety of this drug during pregnancy has not been established, thus caution is needed, and it is recommended that breastfeeding women do not use this drug. The safety and efficacy in children have not been established, therefore it should not be used in this population. In case of overdose, symptoms may include headache, thirst, dizziness, drowsiness, and blurred vision, requiring appropriate emergency treatment. Lastly, this drug has been reported to not have genotoxicity or tumorigenicity, and it does not appear to affect reproductive capacity or fetal development.

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

This drug must be stored in a tightly sealed container to protect it from air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the drug's efficacy and safety.

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets/box [10 tablets/PTP x 10]