Litesolifenacin 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 medicine may be taken with or without food and should be swallowed whole with water. Dosage adjustments are required for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use 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), use with caution and do not exceed 5mg once daily. 3. Patients taking a strong cytochrome P450 3A4 (CYP3A4) inhibitor In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication is an agent that alleviates bladder hyperactivity and should not be used in patients with certain conditions. For example, patients with urinary retention symptoms where urination is difficult or those with severe gastrointestinal diseases should not take this medication. Additionally, patients with myasthenia gravis or angle-closure glaucoma and those allergic to this medicine should also avoid it. It is also not safe for patients with severely impaired kidney or liver function and those undergoing dialysis. Patients with genetic lactose intolerance should not take this medication. This medicine should be used with caution in patients at risk of urinary retention, those at risk of reduced gastrointestinal motility, patients with moderate hepatic impairment, or severe renal impairment. It is also necessary to exercise caution when taken with certain medications, and patients with gastrointestinal-related diseases or autonomic neuropathy should be careful. Common side effects of taking this medication may include dry mouth and constipation, and there may also be blurred vision or difficulty urinating. Rarely, serious side effects such as angioedema, allergic reactions, and arrhythmia may occur, so if symptoms arise, one should consult a physician immediately. Care should be taken when driving or operating machinery, as symptoms such as drowsiness, fatigue, or blurred vision may occur. Taking this medication with other anticholinergic agents may increase its effectiveness or worsen side effects, so follow a doctor's instructions when combining use. Additionally, dosage adjustments may be necessary when taken with certain antifungals or antivirals. Pregnant women should consult a physician before taking this medications as its safety has not been established, and breastfeeding women should avoid use since this medication can be transmitted in breast milk. This medication's safety and efficacy have not been confirmed in children, and use is not recommended. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur and immediate medical attention is required. In case of overdose, administering activated charcoal or other necessary emergency treatments should be carried out. This medication has been reported not to pose a genotoxic or tumorigenic risk, and is known to have no specific effects on reproductive capabilities or fetal development. Before taking this medication, it is important to discuss one’s health status and any other medications being taken with healthcare professionals to ensure safe usage.

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

This medication should be stored in a tightly closed container to prevent air or moisture entry, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

Appearance

Bright yellow round film-coated tablet

Package unit

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