OAV Tablet 10 mg (Solfenacin 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 in 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 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 caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used by patients with urinary retention symptoms, severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma. It should also not be administered to patients with allergies to this drug or its components, patients undergoing hemodialysis, patients with severe liver impairment, severe renal impairment, or certain genetic conditions. Caution is advised in patients at risk of urinary retention or those with obstructive gastrointestinal disease or decreased gastrointestinal motility. Patients with severe renal impairment or moderate hepatic impairment, as well as those taking strong CYP3A4 inhibitors, may also require dose adjustment or careful monitoring. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur. Especially, dry mouth and constipation are more commonly observed with higher doses. Rarely, serious allergic reactions such as angioedema or anaphylaxis may occur; if such symptoms arise, discontinue the medication immediately and seek medical treatment. Caution is also warranted when driving or operating machinery as drowsiness or blurred vision may occur. This medication may have enhanced effects or increased side effects when used with other anticholinergic drugs, thus caution is advised during concurrent use. Additionally, it may reduce the effectiveness of medications that increase gastrointestinal motility. Since this drug is mainly metabolized by the CYP3A4 enzyme, taking it with strong CYP3A4 inhibitors may increase drug concentration, necessitating dosage adjustment. The safety for pregnant women is not established, so use should be cautious if necessary, and it is recommended to avoid use during breastfeeding. The safety and efficacy in children have not been confirmed, so it should not be used in pediatric patients. In cases of overdose, central nervous system symptoms, blurred vision, and dizziness may present, requiring appropriate emergency treatment. It is important to consult with healthcare providers regarding heart disease, electrolyte imbalances, liver, and kidney function states before taking this medication.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius.

Appearance

Bright pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle