Megasolfena Tablet 5 mg (Solfenacin 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 drug 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4(CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), the maximum daily dose should be limited to 5mg.

This medication should not be used by patients with urinary retention symptoms or severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. Additionally, individuals allergic to this medication or its components, patients undergoing hemodialysis, or those with severe liver or kidney disorders should not be treated with this drug. Patients with lactose intolerance should also avoid this medication. Caution is advised when using this medicine in patients at risk of bladder outlet obstruction or those with obstructive gastrointestinal diseases or risk of decreased gastrointestinal motility. Patients with severe kidney impairment or moderate liver impairment should have their doses limited, and caution is also needed when taken with strong CYP3A4 inhibitors. Furthermore, patients with gastroesophageal reflux disease or autonomic neuropathy should also be administered this drug with caution. Common side effects of this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Special attention should be paid as serious gastrointestinal side effects can occur when taken at high doses. Patients with QT prolongation syndrome or hyperkalemia are at risk for cardiac side effects and should be monitored closely. Serious allergic reactions such as angioedema or anaphylaxis may occur; if any of these symptoms appear, the drug should be discontinued immediately and medical attention should be sought. The effects or side effects may be intensified when used with other anticholinergic medications, so caution is required during co-administration. It may also reduce the effectiveness of drugs that increase gastrointestinal motility. Safety during pregnancy has not been established, hence it should only be used cautiously when necessary, and breastfeeding should be avoided as this medication may pass into breast milk. Safety and efficacy have not been confirmed in pediatric patients, and they should not be administered this drug. In cases of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and immediate medical treatment is necessary in case of overdose. Caution should be taken while driving or operating machinery due to the risk of drowsiness or blurred vision leading to accidents.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance

Pale pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP × 10)