Solpena 10 mg (Solifenacin Succinate)

Adult dose

The 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 adjustment is required 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication is used to alleviate bladder hyperactivity. It should not be used in patients with urinary retention symptoms, severe gastrointestinal problems, myasthenia gravis, or closed-angle glaucoma. Additionally, individuals with allergies to this medication or its ingredients, patients undergoing blood dialysis, or those with severe liver or kidney dysfunction should avoid taking it. Caution is advised when using this medication in patients at risk of urinary retention or those with gastrointestinal obstruction or reduced gastrointestinal motility. Dose adjustment may be necessary for patients with severe kidney or liver dysfunction or those taking strong CYP3A4 inhibitors. Common side effects when taking this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Notably, dry mouth and constipation occur more frequently at higher doses. Serious allergic reactions, such as angioedema or anaphylaxis, may occur during treatment; if these symptoms appear, discontinue the medication immediately and consult a healthcare professional. This medication may increase the risk of accidents due to drowsiness or blurred vision while driving or operating machinery, so caution is needed. When taken with other anticholinergic drugs, the effects of this medication may be enhanced or side effects may be aggravated, so caution is warranted in combination therapy. Additionally, interactions may occur with medications that promote gastrointestinal motility. This medication is primarily metabolized by the liver's CYP3A4 enzyme, so co-administration with strong CYP3A4 inhibitors can increase blood concentration and the risk of side effects. In such cases, dose adjustment is required. Safety in pregnant women has not been established; caution should be exercised during pregnancy, and nursing women are advised to avoid using this medication. Safety and efficacy have not been established for pediatric patients; therefore, it should not be used in this population. Overdose may result in symptoms such as headache, dizziness, drowsiness, and blurred vision, necessitating proper treatment. Caution is advised when this medication is used in patients with a history of heart disease or those at risk of QT prolongation.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Light pink round film-coated tablet

Package unit

100 tablets/(10 tablets/PTP X 10)