Samsung Solifenacin Tablets 10mg (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. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

This medication should not be used in patients with urinary retention symptoms, severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. Additionally, individuals allergic to this medication or its components, those undergoing hemodialysis, patients with severe liver impairment, and those with severe renal impairment taking certain medications should not use it. Caution is required in patients with bladder outlet obstruction at risk of urinary retention, gastrointestinal obstruction, or those at risk of decreased gastrointestinal motility. When taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes may occur, particularly at higher doses. Patients with QT prolongation syndrome or hyperkalemia should be cautious as there is a risk of cardiac arrhythmias. Serious allergic reactions such as angioedema or anaphylaxis may occur, and if symptoms arise, immediate discontinuation and medical attention are required. Caution is needed while driving or operating machinery as symptoms such as drowsiness or blurred vision may affect ability. This drug may enhance effects or exacerbate side effects when used with other anticholinergic medications, thus caution is necessary when coadministering. When used with drugs that inhibit CYP3A4 enzymes, dose adjustments are needed, and especially in patients with severe liver or kidney impairment, coadministration should be avoided. Pregnant women should use this medication cautiously as its safety has not been established, and breastfeeding mothers should avoid using it as it may affect the infant through breast milk. Safety has not been established in children, so it should not be administered to them. In cases of overdose, central nervous system symptoms, cardiac arrhythmias, and respiratory failure may occur, thus immediate medical attention should be sought. This medication has not been associated with an increased risk of cancer even with long-term use, nor has there been any direct reported effects on reproductive ability or fetal development.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is best to store the medication at room temperature between 1 to 30 degrees Celsius, avoiding extremes of temperature.

Appearance

Pale pink round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP×10)]