Oavi Tablet 5mg (Solifenacin Succinate)

Adult dosage

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 dosage adjustment is necessary in 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 dosage adjustment is necessary in 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: For 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 administered to patients with urinary retention, severe gastrointestinal problems, myasthenia gravis, or angle-closure glaucoma. Additionally, patients with hypersensitivity to this medication, those undergoing dialysis, patients with severe liver impairment, severe kidney impairment, and those with certain genetic conditions should avoid taking this medication. Caution should be exercised in patients at risk for urinary retention or gastrointestinal obstructive disorders, or those at risk for decreased gastrointestinal motility. For patients with severe kidney impairment or moderate liver impairment, the maximum dosage of this medication should be limited, and caution is needed when used in combination with certain drugs. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with occasional severe gastrointestinal adverse reactions. Serious allergic reactions such as angioedema or anaphylaxis have been reported, so if such symptoms occur, discontinue use immediately and seek appropriate treatment. Care should be taken when driving or operating machinery due to drowsiness or blurred vision. This medication may enhance effects or increase side effects when used with other anticholinergic medications, so caution is advised in such cases. In particular, using it with strong CYP3A4 inhibitors can increase the blood concentration of this medication, necessitating dose adjustments. The safety of this medication during pregnancy is not established, so caution is advised, and it is advisable to avoid the use of this medication during breastfeeding. Safety and efficacy in pediatric patients have not been established, so this medication should not be administered to children. In case of overdose, appropriate treatment should be initiated according to symptoms, and urgent measures may be necessary as severe central nervous system symptoms, respiratory failure, or heart issues may occur.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• indigestion
• epigastric pain
• vomiting
• urinary tract infection

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness over time.

Appearance

Light pink oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2), 98 tablets (14 tablets/PTP×7)