Boryeong Solifenacin Tablets 10 mg (Solifenacin Succinate)

Adult dose

The recommended dose for adults (including older adults) 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; swallow it 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). 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 dose adjustment is required 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication is used to improve bladder overactivity or dysfunction. This drug should not be used in patients with urinary retention, severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. Additionally, patients with allergies to this drug or its components, those undergoing dialysis, and those with severe liver or kidney impairment should not be administered this drug. Patients with a risk of urinary retention, gastrointestinal obstruction, reduced motility, severe renal impairment, moderate liver dysfunction, or those taking strong CYP3A4 inhibitors should use this medication with caution. Taking this medication may result in side effects such as dry mouth, constipation, blurred vision, urinary retention, or dry eyes. These symptoms may occur more frequently, especially at high doses. In rare cases, severe allergic reactions such as angioedema or anaphylaxis may occur, and if these symptoms develop, the medication should be stopped immediately, and medical consultation should be sought. This drug may cause drowsiness, blurred vision, or fatigue while driving or operating machinery. Caution is necessary. Taking this drug with other anticholinergic medications may enhance its effects or worsen side effects, so it should be discussed with a doctor. Also, concomitant use with strong CYP3A4 inhibitors can increase the blood concentration of this drug, necessitating dosage adjustments. Safety in pregnant women has not been established; therefore, pregnant women should use this medication with caution. Breastfeeding women are advised to avoid this drug as it may be excreted in breast milk and affect the newborn. Safety and efficacy have not been established for children, so it should not be administered. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and appropriate emergency treatment should be received if needed. Patients with heart disease or a risk of QT prolongation need to take special care while using this medication. Before taking this drug, it is essential to consult with healthcare professionals to determine the appropriate administration and dosage based on individual conditions.

• 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. It is also recommended to store the drug at room temperature between 1°C and 30°C. It is safe to avoid excessively hot or cold places.

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP X 10), 30 tablets/bottle, 100 tablets/bottle