Solashinjung 5 mg (Solfenacin 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 regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a potent cytochrome P450 3A4 (CYP3A4) inhibitor 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 in patients with urinary retention symptoms, severe gastrointestinal diseases, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should not be administered to patients with allergies to this medication or its ingredients, those undergoing dialysis, or those with severe liver or kidney impairment. Caution should be exercised in patients at risk of urinary retention, those with obstructive gastrointestinal diseases, decreased gastrointestinal motility, or moderate liver impairment. Dosage adjustments are necessary when taken with strong CYP3A4 inhibitors, and caution is also needed in patients with autonomic neuropathy. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particular attention should be paid to the potential for severe gastrointestinal adverse reactions, especially at high doses. This medication may cause cardiac side effects in patients with QT prolongation syndrome or hyperkalemia. If severe allergic reactions such as angioedema or anaphylaxis occur, the medication should be discontinued immediately, and treatment should be sought. Symptoms such as drowsiness, fatigue, and blurred vision may occur when driving or operating machinery, so caution is required. Co-administration with other anticholinergic medications may enhance effects or exacerbate side effects, and it may reduce the effectiveness of medications increasing gastrointestinal motility. When used with strong CYP3A4 inhibitors, drug concentration may increase, necessitating dosage restrictions, and patients with severe renal or liver impairment should avoid such combinations. The safety of this medication in pregnant women has not been established, so it should be used with caution if necessary, and its use should be avoided in breastfeeding women as it can be secreted into breast milk and affect newborns. Safety and efficacy in children have not been confirmed, so it should not be administered to children. In cases of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, requiring appropriate treatment such as activated charcoal. Patients with a history of heart disease or risk factors for QT prolongation should be monitored closely in case of overdose.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)