Solifenacin Tablet 5 mg (Solifenacin 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 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 required for 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 for 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors In 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 symptoms of poor urination. Additionally, it should not be administered to patients with severe gastrointestinal disorders, myasthenia gravis, or glaucoma. Patients who are allergic to this drug, undergoing hemodialysis, or with severe liver or kidney dysfunction should also avoid taking it. This drug is not suitable for patients with genetic issues causing specific sugars to be indigestible. Caution is required for patients with bladder outlet obstruction who have difficulty with urine expulsion or with risk of gastrointestinal obstruction or decreased gastric motility. In patients with moderate to severe impaired renal or liver function, dosage should be limited. Care should also be taken when taken in conjunction with strong CYP3A4 inhibitors, and caution is necessary for individuals with specific gastrointestinal diseases or autonomic neuropathies. Common side effects of this drug include dry mouth, constipation, blurred vision, difficulty urinating, and eye dryness. Occasionally, severe gastrointestinal adverse reactions, angioedema, and allergic reactions have been reported. Caution is required when driving or operating machinery due to drowsiness or blurred vision. This medication may enhance effects or worsen side effects when taken with other anticholinergics, and may reduce the effects of medications that promote gastrointestinal motility. Particularly, when combined with strong CYP3A4 inhibitors such as ketoconazole, dose adjustment is essential. The safety for pregnant women is not established, thus caution is advised when administering. In breastfeeding cases, this drug may be secreted in breast milk and affect newborns, so its use should be avoided. Safety and efficacy in children have not been established, hence it should not be administered to the pediatric population. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, requiring appropriate emergency treatment. Patients with heart disease or electrolyte imbalances should be cautious due to the risk of cardiac side effects such as QT interval prolongation.

• 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 closed container to avoid exposure to air or moisture, and it is safe to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage maintains the drug's effectiveness and prevents deterioration.

Appearance

Bright yellow, round film-coated tablets

Package unit

10 tablets (PTP) X 10