Solasin Tablet 10 mg (Sollifenacin Succinate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required 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 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a potent cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This drug should not be used in patients with urinary retention or serious gastrointestinal disorders such as toxic megacolon. Patients with myasthenia gravis or narrow-angle glaucoma and those who are allergic to this drug or its components should also avoid use. Patients undergoing hemodialysis and those with severe liver or kidney dysfunction may also face risks from using this drug. It is not suitable for patients with certain genetic metabolic disorders. Care should be taken when administering to patients at risk of urinary retention or gastrointestinal obstructive disorders, or who have a risk of reduced gastrointestinal motility. Dose adjustments may be needed for patients with severe renal and hepatic impairment, or who are taking potent CYP3A4 inhibitors. Patients with gastroesophageal reflux disease or autonomic neuropathy also require caution. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly, dry mouth and constipation are more frequent with higher dosages, and in rare cases, serious gastrointestinal obstruction may occur. Patients with QT prolongation syndrome or hyperkalemia are at risk of cardiac arrhythmias and should be monitored closely. If allergic reactions such as angioedema or anaphylaxis occur, medication should be stopped immediately, and treatment should be initiated. Caution is needed when driving or operating machinery due to drowsiness, blurred vision, and fatigue that may increase the risk of accidents. This medication may enhance the effects or worsen side effects when taken with other anticholinergic drugs, so care should be taken with concomitant use. Interactions may also occur with medications that increase gastrointestinal motility. This drug is primarily metabolized by the CYP3A4 enzyme, so taking it with strong CYP3A4 inhibitors may increase drug concentration and the risk of side effects. In such cases, dosage should be limited, and it is best to avoid concommitant use in patients with severe liver or kidney impairments. Safety has not been established during pregnancy, so it should be used cautiously, and it is advisable to avoid use during breastfeeding as the drug may be excreted in breast milk. Use in pediatric patients is not recommended as safety and efficacy have not been verified. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and appropriate treatment such as activated charcoal may be needed. Severe CNS symptoms, cardiac arrhythmias, and urinary retention may require professional medical treatment. There have been no reported increases in tumor risk with long-term use of this medication, and there were no effects on reproductive ability or fetal development observed in animal studies.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage will help ensure the medication's effectiveness.

Appearance

Pale pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)