Solistop Tablet 5mg (Solifenacin Succinate)

Adult dose

The 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 medicine 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 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 necessary 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 strong cytochrome P450 3A4 (CYP3A4) inhibitor : 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 certain patients. For example, it is contraindicated in patients with urinary retention, severe gastrointestinal disease, myasthenia gravis, or narrow-angle glaucoma. Patients allergic to any ingredient in this medication or those undergoing hemodialysis, as well as patients with severe liver or kidney dysfunction, should also avoid using this medication. Caution is required for patients at risk. For instance, patients with urinary outflow obstruction, gastrointestinal obstruction, or moderate to severe kidney or liver dysfunction should have their dosage limited or use this medication under strict supervision. Common side effects include dry mouth, constipation, blurred vision, urinary difficulties, and dry eyes. These symptoms may occur more frequently when higher doses are used. Rarely, serious side effects, such as angioedema, allergic reactions, heart rhythm disturbances, liver function abnormalities, may occur, and any unusual symptoms should be reported to a healthcare professional immediately. This medication may enhance the effects or side effects of other anticholinergic medications and can decrease the efficacy of medications that promote gastrointestinal motility. Because this medication is metabolized in the liver by specific enzymes (CYP3A4), the dosage should be reduced when taken with strong inhibitors of these enzymes. Women who are pregnant or breastfeeding should exercise caution when using this medication; notably in breastfeeding, since it may pass into breast milk and affect the infant, its use should be avoided whenever possible. It is not recommended for children due to insufficient evidence of safety and efficacy. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, necessitating appropriate emergency measures such as gastric lavage or charcoal treatment. This medication may increase the risk of accidents while driving or operating machinery due to drowsiness or blurred vision.

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

Store this medication in a tightly sealed container to avoid exposure to air or moisture, at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer time.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP × 10)