Solpene 5 mg (Solfenaine Succinate)

Adult dose

The 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 used in patients with urinary retention symptoms where urination is difficult. Patients with toxic megacolon or severe gastrointestinal problems should also not take this medication. This medication is not suitable for patients with myasthenia gravis, which causes muscle weakness. Patients with angle-closure glaucoma should not use this medication as it may raise eye pressure. Patients with a known allergy to this medication or its components should avoid taking it. Patients undergoing dialysis and those with severe liver impairment (Child-Pugh class C) should also refrain from using this medication. In patients with severe renal impairment or moderate liver impairment who are taking potent CYP3A4 inhibitors, caution should be exercised when using this medication. Patients with genetically determined galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should also avoid this medication. Caution is advised for patients at risk of urinary outlet obstruction or those with gastrointestinal obstruction or reduced gastrointestinal motility. Patients with severe renal impairment or moderate liver impairment should limit daily maximum dosage to 5 mg. Patients taking potent CYP3A4 inhibitors should also be closely monitored for dosage adjustments. Patients taking medications that may worsen gastroesophageal reflux disease or esophagitis, as well as those with autonomic neuropathy, should also exercise caution. Taking this medication may cause dry mouth and constipation, and symptoms such as blurred vision or difficulty urinating may occur. There may be instances of discontinuing the medication due to adverse reactions, particularly due to the most common symptom of dry mouth. During treatment, dizziness, drowsiness, or fatigue may occur, so caution is advised when driving or operating machinery. Taking this medication in conjunction with other anticholinergic medications may increase efficacy or the occurrence of side effects. This medication may also reduce the effects of medications that promote gastrointestinal motility. This medication is metabolized by certain enzymes (CYP3A4) in the liver, so taking it with drugs that strongly inhibit this enzyme may increase drug concentration. Particularly, when taken with strong CYP3A4 inhibitors like ketoconazole, dosage reduction is necessary. Safety for pregnant women has not been established, so it is important to exercise caution if pregnant women take it. Breastfeeding women should not use this medication as it may pass to the baby through breast milk. Safety and effectiveness in children have not been established, and it should not be given to them. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, requiring appropriate emergency treatment. Patients with heart diseases or electrolyte abnormalities should be particularly cautious due to the risk of heart rhythm disturbances when taking this medication.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/(10 tablets/PTP X 10)