Solifenacin Tablets 10mg (Solifenacin Succinate)

Adult dose

The recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. No dose adjustment is necessary 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 5 mg once daily. No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5 mg once daily. For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5 mg.

This medication should not be used in patients with urinary retention symptoms, severe gastrointestinal disease, myasthenia gravis, or angle-closure glaucoma. Patients undergoing hemodialysis or with severe liver or kidney impairment should also avoid this medication. Patients with genetic galactose intolerance should also avoid this medication. Caution should be exercised in patients with potential urinary retention due to bladder outlet obstruction, obstructive gastrointestinal disease, or reduced gastrointestinal motility. In cases of severe renal impairment or moderate liver impairment, the dosage should be limited when used in conjunction with strong CYP3A4 inhibitors. Patients taking drugs that may induce or worsen gastroesophageal reflux or esophagitis should also be cautious. This medication may cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with dry mouth and constipation being reported commonly. In severe cases, serious adverse reactions such as intestinal obstruction or angioedema may occur, so consult a physician immediately if any abnormal symptoms appear. Patients with QT prolongation syndrome or hyperkalemia should be cautious as there is a risk of cardiac arrhythmias. Angioedema or anaphylaxis may occur, so if such symptoms appear, administration should be stopped immediately, and treatment should be sought. Caution is required when driving or operating machinery as drowsiness, blurred vision, and fatigue may occur. This medication may enhance effects or increase side effects when taken with other anticholinergic medications, so combination should be approached with caution. When taken with strong CYP3A4 inhibitors, the blood concentration of this medication may increase, necessitating dosage adjustment. Safety has not been established for pregnant women, so caution is needed during use; lactating women should avoid using this medication. Safety and efficacy in children have not been confirmed, so it should not be administered to children. In case of overdose, central nervous system symptoms or cardiac arrhythmias may appear, requiring immediate medical treatment, and detoxification treatment may be necessary if needed.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance

Bright pink circular film-coated tablet

Package unit

100 tablets (10 tablets/PTPX10)