Soltonisin Tablet 10mg (Soli pherazine succinate)

Adult dose

The usual recommended dose for adults (including the elderly) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medication 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 dosage adjustment is necessary for 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 for 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used in patients with urinary retention, severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to patients with hypersensitivity to this drug or its components, patients on hemodialysis, or those with severe liver or kidney dysfunction. Caution is advised when using in patients at risk for urinary retention, those with gastrointestinal obstruction, decreased gastrointestinal motility, severe renal impairment, or moderate liver impairment, and dosage adjustment may be necessary in such cases. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, particularly at high doses where the risk of side effects increases. Other symptoms such as cough, dizziness, fatigue, and hypertension may occur infrequently, so caution is warranted. If symptoms of serious allergic reactions such as angioedema or anaphylaxis occur during use of this medication, it should be discontinued immediately and medical treatment sought. Caution should be exercised while driving or operating machinery, as symptoms such as drowsiness or blurred vision may manifest. Using with other anticholinergic medications may enhance the effects or aggravate side effects; therefore, caution is needed when used in combination. This medication is metabolized by specific liver enzymes (CYP3A4), thus dosage adjustment is required when taken concurrently with drugs that strongly inhibit this enzyme. The safety of this medication in pregnancy is not established, so it should be used cautiously in pregnant women, and preferably avoided during breastfeeding. Safety and efficacy have not been established in pediatric patients, so it should not be administered to children. In case of overdose, central nervous system symptoms, blurred vision, and dizziness may occur, necessitating immediate medical attention for appropriate treatment. Particular caution is needed for patients with pre-existing heart conditions, electrolyte imbalances, or at risk of QT interval prolongation.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

This medication should be stored in a tightly closed container to prevent air and moisture from entering. Also, it is best to keep the medication at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)