Solvena Tablets 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 necessary 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), administer 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), administer with caution and do not exceed 5mg once daily. 3. Patients taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking 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, severe gastrointestinal disorders, severe myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to individuals who are allergic to this drug or its components, those undergoing hemodialysis, and those with severe liver or kidney dysfunction. Patients at risk for urinary retention or with gastrointestinal obstructive diseases or risk of decreased gastrointestinal motility should use this medication cautiously, especially if renal or liver function is moderately impaired or more, in which case the dosage should be limited. Caution is also warranted when used with strong CYP3A4 inhibitors. Side effects may include dry mouth, constipation, blurred vision, urinary retention, ocular dryness, dizziness, depression, nausea, indigestion, abdominal pain, vomiting, fatigue, cough, hypertension, urinary tract infections, influenza, pharyngitis, lower extremity edema, difficulty urinating, decreased urinary flow, post-void residual, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, renal impairment, itching, rash, angioedema, erythema multiforme, exfoliative dermatitis, atrial fibrillation, and palpitations. Serious allergic reactions such as angioedema or anaphylaxis have been reported rarely; if such symptoms occur, the medication should be discontinued immediately and treatment sought. There is also a risk of accidents due to drowsiness or blurred vision when driving or operating machinery. This medication may enhance the effects or worsen the side effects of other anticholinergic drugs; therefore, consulting a healthcare professional is advisable when used concomitantly. It may also reduce the effectiveness of gastrointestinal motility agents. Since this medication is metabolized in the liver, using it with strong CYP3A4 inhibitors may increase plasma concentrations, elevating the risk of side effects. In these cases, dosage adjustments or avoidance of concomitant use is necessary. Safety has not been established for pregnant women, so it should be used cautiously and only when necessary. During breastfeeding, this medication can be excreted into breast milk and may harm the newborn; therefore, it is best to avoid use. The safety and efficacy in pediatric patients have not been established, so it should not be administered to children. In case of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and gastric lavage or medical treatment may be needed. Patients with cardiovascular diseases or at risk for QT prolongation should be particularly cautious regarding cardiac side effects in the event of an overdose. No reports have indicated genotoxicity or risks of tumor occurrence, even with long-term use, and it is known not to affect reproductive capacity.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Avoid extremely hot or cold places, and it is recommended to store at a temperature between 1°C and 30°C, which is room temperature.

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)