Solifenacin Tablets 5 mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) 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 in the following patients. 1. Patients with renal impairment: No dosage adjustment is necessary in patients with mild to 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 dosage adjustment is necessary in 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 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 patients with certain conditions. For example, it should not be administered to patients with urinary retention symptoms or severe gastrointestinal issues, patients with myasthenia gravis, and patients with closed-angle glaucoma with elevated eye pressure. Additionally, patients with hypersensitivity to this drug or currently undergoing dialysis, as well as those with severe liver or kidney dysfunction, should also avoid this medication. Patients with specific genetic metabolic disorders should not take this medicine. Care must be taken when administering this drug to patients at risk for urinary retention, patients with intestinal obstruction or decreased gastrointestinal motility, and those with severe kidney or liver impairment. Also, dosage adjustments may be necessary when used in conjunction with certain medications, and caution should be exercised in patients with gastroesophageal reflux disease, hernias, or autonomic neuropathy. Common side effects of this drug include dry mouth, constipation, blurred vision, urinary retention, dry eyes, dizziness, depression, nausea, dyspepsia, abdominal discomfort, vomiting, urinary tract infection, influenza, pharyngitis, leg edema, fatigue, cough, hypertension, difficulty urinating, decreased urinary flow, bladder distention, cystitis, nasopharyngitis, headaches, hallucinations, drowsiness, delirium, kidney impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, prolonged QT interval on ECG, and liver dysfunction. Serious allergic reactions such as angioedema or anaphylaxis may occur rarely, and if such symptoms appear, immediate discontinuation of the drug and medical treatment is necessary. Caution is advised when driving or operating machinery, as drowsiness or fatigue may occur. The effectiveness of this drug may be enhanced or its side effects may become more severe when used with other anticholinergic medications, so care should be taken when administering concurrently. Additionally, it may diminish the effects of drugs that increase gastrointestinal motility. Concurrent use with strong inhibitors of the enzyme CYP3A4 that metabolizes this drug in the liver may increase its concentration in the blood, necessitating dosage adjustments. Pregnant or breastfeeding women should consult a physician before using this medication, and it is not recommended for children as safety and efficacy have not been established. In case of overdose, appropriate treatment based on symptoms is required, following medical guidance. Before using this medication, patients should inform their healthcare provider of their health status and any other medications they are taking, and report any adverse reactions immediately.

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

Store this medication in a tightly sealed container to protect it from air and moisture. It is best to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle