Solitos Orally Disintegrating Tablet 10 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. 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. 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. For patients taking 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 conditions, myasthenia gravis, or angle-closure glaucoma. Additionally, those allergic to this medication or its ingredients, patients undergoing dialysis, those with severe liver impairment, severe kidney impairment, or taking certain medications should not use this medication. Caution is needed when used by individuals at risk of urinary retention or those with gastrointestinal obstructive diseases, reduced gastrointestinal motility, severe kidney impairment, or moderate liver impairment, and those taking certain medications concurrently. Patients may experience side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes while on this medication. In particular, dry mouth and constipation are common, and serious gastrointestinal issues may occur rarely. Caution is necessary when driving or operating machinery, as symptoms such as drowsiness or blurred vision may occur. Furthermore, the effectiveness of this medication may increase or side effects may worsen when taken with other anticholinergic medications, so caution is warranted when taken concurrently. This medication is primarily metabolized by the CYP3A4 enzyme in the liver, thus taking it with drugs that strongly inhibit this enzyme may increase drug concentration, necessitating dose adjustment. Its safety for pregnant women is not established, so it should be used with caution. For nursing mothers, it is advisable to avoid use as the drug may be excreted in breast milk. The safety and efficacy in pediatric patients have not been established, so it should not be administered to children. In cases of overdose, inducing vomiting should be avoided, and if necessary, activated charcoal administration or professional treatment may be required. This medication should be used with caution in patients with heart conditions or who are at risk of QT prolongation, and if signs of angioedema or anaphylaxis occur, administration should be ceased immediately and treatment sought.

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

This medication should be stored in a tightly sealed container to protect from air and moisture. It is best to store it at room temperature, i.e., 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]