Solifenacin Tablet 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 regardless of meals 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). 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 dose 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 another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used in patients with urinary retention symptoms, severe gastrointestinal conditions, myasthenia gravis, or narrow-angle glaucoma. Additionally, patients with hypersensitivity to this drug or its components, those undergoing dialysis, and patients with severe liver or kidney impairment should not receive this medication. Use with caution in patients at risk of urinary retention or those with gastrointestinal obstructive diseases, decreased gastrointestinal motility, severe renal impairment, or moderate liver impairment. Caution is also necessary when used in conjunction with potent CYP3A4 inhibitors, and patients with certain gastrointestinal diseases or autonomic neuropathy should be monitored. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, dizziness, depression, nausea, dyspepsia, upper abdominal pain, vomiting, urinary tract infections, influenza, pharyngitis, leg edema, fatigue, cough, hypertension, urination difficulties, decreased urinary flow, bladder fullness, cystitis, rhinitis, headache, hallucinations, drowsiness, confusion, kidney impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, QT prolongation on electrocardiogram, hepatic dysfunction. In severe cases, serious gastrointestinal adverse reactions such as bowel obstruction or fecal impaction may occur; hence, immediate consultation with a physician is required if symptoms worsen. If allergic reactions such as angioedema or anaphylaxis occur during the use of this medication, it should be discontinued immediately, and appropriate treatment must be sought. Caution is advised while driving or operating machinery due to possible drowsiness, blurred vision, or fatigue. This medication may enhance the effects or side effects of other anticholinergic drugs, so consult a physician when using them together. Additionally, it may reduce the effectiveness of gastrointestinal motility-increasing drugs, so inform your physician about any co-administered medications. This drug is metabolized in the liver; therefore, concurrent use with potent CYP3A4 inhibitors may increase drug concentration, necessitating dosage adjustments. The safety of this drug has not been established in pregnant women, so caution is necessary when administered, and it is advisable to avoid use during breastfeeding. The safety and efficacy in pediatric patients have not been confirmed, thus it should not be administered to children. In case of overdose, administration of activated charcoal and appropriate treatment is required, and severe central nervous system symptoms or cardiac issues may arise, so immediate notification to healthcare personnel is necessary. Before taking this medication, it is crucial to discuss existing conditions or concurrent medications with healthcare personnel.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colon obstruction
• intestinal blockage
• angioedema
• nausea

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best stored at room temperature between 1 degree and 30 degrees, avoiding extremely hot or cold conditions.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP*10), 30 tablets/bottle, 100 tablets/bottle