Solpezin Tablet 5 mg (Solfenacin Succinate)

Adult dose

Adults (including elderly patients): The recommended dose 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 in the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or 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 dose 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used in patients with symptoms of poor urine output. It may be dangerous for patients with serious gastrointestinal issues or myasthenia gravis. Patients with glaucoma who have elevated eye pressure or those who have allergic reactions to this medication should avoid its use. Patients receiving hemodialysis or those with severely impaired liver and kidney functions should not be administered this drug. Patients with genetic conditions affecting lactose digestion should avoid this medication as it contains lactose. Patients at risk of urinary retention or those with gastrointestinal obstruction or decreased motility should use this medication cautiously. Patients with moderate to severe hepatic or renal impairment must strictly adhere to the maximum daily dose. Caution is also required when taking this medication with strong CYP3A4 inhibitors. Patients with gastroesophageal reflux disease or esophagitis should be careful as their condition may worsen upon taking this medication. Patients with autonomic nervous system disorders should also be cautious when using this drug. Common side effects of this medication include dry mouth and constipation. Symptoms such as dry eyes or blurred vision, and difficulty in urination may occur. In severe cases, serious gastrointestinal issues such as bowel obstruction may arise; hence, immediate consultation with healthcare professionals is necessary if symptoms appear. If dry mouth worsens during the course of treatment, discontinuation of the medication may be required. This medication can cause cardiac rhythm abnormalities such as QT interval prolongation; therefore, patients with heart conditions or electrolyte imbalances should be cautious. Serious allergic reactions such as angioedema or anaphylaxis can occur, necessitating immediate cessation of use and appropriate medical treatment if such symptoms arise. This drug may also cause drowsiness, fatigue, and blurred vision, so caution is needed when driving or operating machinery. Combining this medication with other anticholinergic drugs can enhance effects or increase side effects. Using medications that promote gastrointestinal motility may reduce the effectiveness of this drug. Since this medication is metabolized by certain enzymes in the liver, taking it with drugs that strongly inhibit those enzymes can increase the serum concentration of this drug, raising the risk of side effects. Especially when combined with strong CYP3A4 inhibitors like ketoconazole, the daily maximum dose should be limited. The safety of this medication in pregnant women has not been established; therefore, pregnant women should use it cautiously. Nursing mothers should avoid taking this medication as it may be excreted in breast milk, potentially affecting the infant. The safety and efficacy of this drug have not been established for pediatric patients, so its use in this population is discouraged. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may appear, and appropriate treatment such as gastric lavage or administration of activated charcoal may be necessary. Patients experiencing severe central nervous system symptoms, respiratory failure, or tachycardia require specialized treatment. Patients with a history of heart disease or electrolyte abnormalities should be particularly cautious when overdosing.

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

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

Appearance

Round film-coated tablet, bright yellow in color

Package unit

30 tablets/bottle, 100 tablets/bottle