Solferisin Tablets 10 mg (Solefenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) 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. Patients with renal impairment: No dosage 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. Patients with hepatic impairment: No dosage 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. Patients receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors: In patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used by individuals with urinary retention symptoms or severe gastrointestinal diseases such as toxic megacolon. It should also not be taken by patients with myasthenia gravis or angle-closure glaucoma. Patients with allergies to this medication, those undergoing hemodialysis, severe liver impairment, or kidney impairment should also avoid use. Individuals with certain genetic diseases such as lactase deficiency or galactose intolerance should avoid this medication as well. Caution is advised for patients at risk of urinary retention or those with obstructed bladder outflow, patients with obstructive gastrointestinal disease, or those at risk of reduced gastrointestinal motility. Patients with severe kidney impairment or moderate liver impairment should limit the maximum daily dose and be cautious when used in conjunction with potent CYP3A4 inhibitors. Patients with gastroesophageal reflux or autonomic neuropathy should also use this medication with caution. This medication may commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly at high doses, significant gastrointestinal adverse reactions may occur, so caution is advised. Patients with QT prolongation syndrome or hyperkalemia may have an increased risk of cardiac arrhythmias when using this medication. In case of serious allergic reactions such as angioedema or anaphylaxis, immediately stop drug administration and receive appropriate treatment. Care should be taken when driving or operating machinery, as symptoms such as blurred vision, drowsiness, and fatigue may occur. Using this medication in conjunction with other anticholinergic drugs may enhance effects or worsen side effects, so caution is necessary. This medication may reduce the effectiveness of drugs that increase gastrointestinal motility. As this medication is primarily metabolized by the liver, when used with potent CYP3A4 inhibitors, the dose should be reduced, and patients with severe kidney or liver impairment should avoid combination therapy. Safety during pregnancy has not been established, so caution is advised regarding its use during pregnancy, and it is preferable to avoid use while breastfeeding as this medication may pass into breast milk. Safety and efficacy in children have not been confirmed, thus it should not be administered to pediatric patients. In cases of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may appear; activated charcoal administration and appropriate emergency care should be sought if necessary. This medication has not shown genetic toxicity, and it has been confirmed not to affect tumorigenesis or reproductive capacity in animal studies.

• 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 closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP X 10)