Solifenacin 5 mg (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. Dosage 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). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5 mg once daily. 2. Patients with hepatic impairment 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. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors 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. It should also not be administered to patients with severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma. It is also safe not to use in patients with allergies to this drug or its components, patients undergoing dialysis, and patients with severe liver dysfunction. Caution is needed in patients with severe renal impairment or moderate liver impairment who are taking strong CYP3A4 inhibitors. This medication should not be administered in patients with certain genetic metabolic disorders. Caution is required when using in patients at risk of urinary retention or bladder outlet obstruction, gastrointestinal obstructive diseases, or reduced gastrointestinal motility. For patients with severe renal impairment or moderate liver impairment, the maximum daily dose should be restricted, and caution is needed when taken together with strong CYP3A4 inhibitors. In addition, careful administration is required in patients taking medications that may cause gastroesophageal reflux disease or esophagitis and patients with autonomic neuropathy. Possible side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes when taking this medication. Dry mouth and constipation are common, and the frequency increases with higher doses. In severe cases, serious gastrointestinal side effects such as intestinal obstruction may occur, so caution is advised. Patients with longer QT syndrome or hyperkalemia may have a risk of cardiac rhythm disturbances when taking this medication. If allergic reactions such as angioedema or anaphylaxis occur, drug administration should be stopped immediately, and appropriate treatment should be received. Other causes of urinary issues should be evaluated first, and if there is a urinary tract infection, antibacterial treatment should be initiated. Taking this medication together with other anticholinergic drugs may enhance efficacy or worsen side effects. It may reduce the effect of medications that increase gastrointestinal motility, so caution is required when co-administering. This medication is metabolized by the CYP3A4 enzyme, and taking it with strong CYP3A4 inhibitors may increase blood concentration necessitating dose adjustments. Safety of this medication during pregnancy has not been established, so caution is required when administered, and during breastfeeding, it is advisable to avoid use as this medication may be excreted in breast milk. Safety and efficacy in pediatric patients have not been confirmed, so it should not be administered to children. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and in severe cases, appropriate emergency treatment may be needed. In case of overdose, the administration of activated charcoal and gastric lavage may be considered, however, inducing vomiting should be avoided. Severe central anticholinergic effects, seizures, respiratory failure, etc., require professional treatment.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)