Solysin Tablet 5mg (Solfenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased up to a maximum of 10 mg once daily. This drug 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 for patients with mild to moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

This drug should not be used in patients with difficulty urinating, severe gastrointestinal problems, myasthenia gravis, and certain types of glaucoma. Also, it should be avoided in patients with hypersensitivity to this drug, those undergoing dialysis, or those with severe liver or kidney dysfunction. Caution should be exercised in patients with a risk of bladder outlet obstruction, those with gastrointestinal obstruction, or those at risk of decreased gastrointestinal motility. Additionally, patients with moderate to severe renal or liver impairment and those taking strong CYP3A4 inhibitors may require close monitoring. Common side effects of this medication include dry mouth, constipation, blurred vision, and dyspepsia, with rare but severe adverse reactions such as gastrointestinal obstruction or angioedema potentially arising. If severe allergic reactions such as angioedema or anaphylaxis occur, medication use must be stopped immediately and appropriate treatment sought. This medication may require caution when driving or operating machinery due to drowsiness or blurred vision. Using this drug in combination with other anticholinergic agents may enhance effects or increase side effects, so care must be taken with concomitant use. This oral medication is metabolized by specific enzymes in the liver; using it concurrently with strong enzyme inhibitors may lead to increased drug concentrations necessitating dosage adjustments. Its safety during pregnancy has not been established, so caution is necessary when used; during breastfeeding, this medication can be transferred to breast milk and may affect the infant, so its use is best avoided. Safety and efficacy in pediatric patients have not been established, so it should not be administered to children. In cases of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and in severe cases, professional medical treatment may be required. Prior to taking this medication, individuals with pre-existing heart conditions or electrolyte imbalances, particularly those at risk for QT interval prolongation, should consult their healthcare provider.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• bowel obstruction
• colon obstruction
• vascular edema
• nausea
• indigestion

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medicine.

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle