Samsung Solifenacin Tablets 5mg (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 necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do 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 medication should not be used in patients with symptoms of impaired urination, those with serious gastrointestinal problems, patients with severe myasthenia gravis, or patients with glaucoma. Additionally, it should not be administered to those allergic to this medication or its components, patients undergoing hemodialysis, patients with very poor liver or kidney function, and patients with certain genetic issues. Caution should be exercised when used in patients at risk of urinary obstruction or with gastrointestinal obstruction, those at risk of reduced gastrointestinal motility, patients with moderate to severe impairment of kidney or liver function, and those taking certain potent medications. This medication can cause symptoms such as dry mouth, constipation, blurred vision, difficulty urinating, and dry eyes, and may sometimes result in serious gastrointestinal issues, angioedema, or allergic reactions. Therefore, if any abnormal symptoms arise, immediate consultation with healthcare professionals is advised. While taking this medication, drowsiness, fatigue, or blurred vision may occur, so caution is needed when driving or operating machinery. Co-administration with other anticholinergic drugs may increase the effectiveness or exacerbate side effects, and it can reduce the effects of medications that increase gastrointestinal motility. This medication is metabolized in the liver, so dosage adjustments are necessary when taken by patients with poor liver function or in conjunction with potent liver enzyme inhibitors. Safety during pregnancy has not been established, so caution is advised when using this medication. It is also recommended to avoid use while breastfeeding as this medication may be excreted in breast milk. Safety and efficacy in children have not been established, hence it should not be administered to them. Overdose may lead to symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision; severe symptoms may require professional medical treatment. Patients with heart diseases, electrolyte abnormalities, or risk of QT interval prolongation should be particularly cautious of cardiac side effects when taking this medication.

• 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 sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. This storage conditions will help to maintain the medication's effectiveness for a longer duration.

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP×10)]