Solitos Orally Disintegrating Tablet 5 mg (Solifenacin Succinate)

Adult dose

For adults (including the elderly), the recommended dose 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. Place it on the tongue, allow it to dissolve in saliva, and swallow. It disintegrates in the mouth but is not absorbed through the oral mucosa. Dose adjustment is required for the following patients. 1. Patients with renal impairment No dose 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 dose 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 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 drug should not be administered to patients with phenylketonuria, as the artificial sweetener aspartame contained in this drug is metabolized into phenylalanine in the body. This drug should not be used in patients with urinary retention, toxic megacolon, myasthenia gravis, or angle-closure glaucoma. Additionally, individuals allergic to this drug or its components, patients undergoing dialysis, patients with severe liver impairment, patients with severe renal impairment, and those taking strong CYP3A4 inhibitors should also avoid administration. Use with caution in patients at risk of urinary retention or those with gastrointestinal obstructive diseases, those at risk of decreased gastrointestinal motility, patients with moderate liver impairment or severe renal impairment, patients taking strong CYP3A4 inhibitors in combination, patients with gastroesophageal reflux disease, or those with autonomic neuropathy. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Dry mouth and constipation are especially common, and the incidence of side effects may increase with high doses. Rarely, angioedema, serious gastrointestinal adverse reactions, and anaphylaxis have been reported, so patients should consult a doctor immediately if any unusual symptoms occur. This drug poses a risk of cardiac arrhythmias in patients with QT prolongation syndrome or hyperkalemia, so caution is required. If angioedema or anaphylaxis occurs, treatment should be stopped immediately, and appropriate care should be sought. Caution is needed when driving or operating machinery as this drug may cause drowsiness, blurred vision, or fatigue. This drug may increase efficacy or exacerbate side effects when used in combination with other anticholinergic drugs, so caution is advised. It may also reduce the effectiveness of medications that increase gastrointestinal motility. When used in conjunction with strong CYP3A4 inhibitors, the blood concentration of this drug may increase, necessitating dosage adjustment, and patients with severe renal impairment or moderate liver impairment should avoid such combinations. The safety of this drug during pregnancy has not been established; thus it should be used with caution in pregnant women, and its use during lactation should be avoided. The safety and effectiveness in pediatric patients have not been confirmed, so administration to pediatric patients should be avoided. In case of overdose, central nervous system symptoms, cardiac arrhythmias, and urinary retention may occur, so immediate medical attention should be sought for appropriate treatment.

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

This drug must be stored in a tightly sealed container to avoid exposure to air or moisture. Also, to maintain its effectiveness, it is important to store it at room temperature between 1°C and 30°C.

Appearance

Pale yellow round orally disintegrating tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 100 tablets/box [10 tablets/PTP x 10]