Solphenicin 5 mg (Solipecan Sodium 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. Dosage adjustment is necessary for the following patients. 1. 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. 2. 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. 3. 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 in patients with urinary retention symptoms or severe gastrointestinal diseases such as toxic megacolon. Caution is also needed for patients with myasthenia gravis or angle-closure glaucoma, as this medication may be dangerous for them. Additionally, it is not administered to patients allergic to this drug or its components, patients undergoing hemodialysis, and patients with severe liver or kidney disorders. Patients with certain genetic metabolic issues should also avoid this medication. Caution is required for patients at risk of urinary retention or with narrowed bladder outlets, patients with gastrointestinal obstruction, and patients at risk of decreased gastrointestinal motility. Patients with severe kidney or liver dysfunction should limit the maximum daily dose and dose adjustment is necessary when combined with strong CYP3A4 inhibitors. Patients taking medications that may induce or worsen gastroesophageal reflux or esophagitis, and those with autonomic neuropathy should also be cautious. This medication can commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes, particularly at high doses. In severe cases, gastrointestinal serious side effects such as fecal obstruction or intestinal obstruction may occur, and if symptoms appear, immediate consultation with medical personnel is necessary. This medication poses a risk of cardiac side effects such as QT interval prolongation, so patients with heart disease or electrolyte abnormalities should be cautioned. Severe allergic reactions such as angioedema or anaphylaxis may occur; if such symptoms occur, the medication must be stopped immediately, and treatment should be sought. Caution is needed when driving or operating machinery, as blurred vision, drowsiness, and fatigue can occur. When taken with other anticholinergic medications, the effect may be enhanced or side effects may worsen, so caution is needed in such combinations. Additionally, it may reduce the effectiveness of medications that promote gastrointestinal motility. Since this medication is primarily metabolized by the CYP3A4 enzyme, taking it with strong CYP3A4 inhibitors can increase the drug concentration, raising the risk of side effects. Therefore, dose adjustment is required when used with such drugs. Its safety during pregnancy is not established, hence special care is needed, and nursing mothers are advised to avoid its use due to its potential secretion into breast milk. Safety and efficacy in children have not been confirmed; therefore, it should not be administered to children. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur; appropriate treatment such as gastric lavage or administration of activated charcoal may be necessary. Professional treatment is required for serious central nervous system symptoms or cardiac side effects.

• 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 at room temperature.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)