Vesicam Tablets 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. No dose 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. No dose 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. For patients taking ketoconazole or another potent 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 or severe gastrointestinal disorders. It should also not be administered to patients with severe myasthenia gravis, angle-closure glaucoma, or allergies to this medication or its ingredients. Patients undergoing hemodialysis and those with severe liver or kidney dysfunction should not use this medication. It should not be given to patients with certain genetic metabolic disorders. Patients at risk of urinary retention or those with gastrointestinal obstructive diseases or decreased gastrointestinal motility should use this medication with caution. Patients with moderate to severe kidney or liver function impairment should also have their dosage limited. Caution is necessary when taken with strong CYP3A4 inhibitors. Patients with certain hernias or gastroesophageal reflux disease, as well as those with autonomic neuropathy, should also be administered this medication carefully. Common side effects of this medication include dry mouth, constipation, blurred vision, urinary retention, dry eyes, peripheral edema, fatigue, cough, hypertension, nausea, indigestion, abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, dysuria, decreased urinary flow, post-void residual, cystitis, nasopharyngitis, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, increased serum creatinine levels, facial swelling, frequent urination, urination disorders, urinary urgency, neurogenic bladder, skin tingling, diarrhea. This medication can rarely cause serious allergic reactions, angioedema, or anaphylaxis, so if symptoms occur, administration should be stopped immediately and treatment sought. Caution is required during driving or operating machinery while taking this medication, as it may cause drowsiness, fatigue, or blurred vision. When taken with other anticholinergic medications, effects may be enhanced or side effects may worsen, so consultation with a healthcare provider is recommended. This medication is metabolized by specific enzymes (CYP3A4) in the liver, so taking it with drugs that strongly inhibit these enzymes can increase its blood concentration. In such cases, dosage adjustment is required, and patients with severe liver or kidney impairment should avoid such combinations. The safety of this medication has not been established in pregnant women, so it should be used cautiously, and breastfeeding women are advised to avoid its use. The safety and efficacy in pediatric patients have not been confirmed, so it should not be used in children. In case of overdose, emesis should be avoided, and appropriate treatment such as activated charcoal should be administered. In case of severe central nervous system symptoms or cardiac irregularities, specialized treatment is required.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eye
• 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. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP pack x 10), 30 tablets/bottle, 100 tablets/bottle