Eurocare Tablets 5 mg (Solifenacin Succinate)

Adult dose

Usually, the recommended dose for adults (including elderly patients) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. The dosage regimen should be adjusted for 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 receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors 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 urinary retention symptoms or serious gastrointestinal problems such as toxic megacolon. It should also be avoided in patients with myasthenia gravis, angle-closure glaucoma, those allergic to this medication or its components, patients undergoing hemodialysis, and those with severe liver or kidney diseases. Patients with genetic issues like galactose intolerance should not take this medication. It should be used cautiously in patients with bladder outlet obstruction at risk of urinary retention or those with gastrointestinal obstructive diseases, as well as in patients who are at risk for decreased gastrointestinal motility. For patients with severe renal impairment or moderate liver impairment, care must be taken not to exceed the maximum dose, and caution is needed when taken with strong CYP3A4 inhibitors. Patients taking medications that can exacerbate heat exhaustion, gastroesophageal reflux, or esophagitis, as well as autonomic neuropathy patients, should also exercise caution. This medication can commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Especially, dry mouth and constipation occur more frequently at higher doses, and rarely, more serious gastrointestinal issues such as angioedema or severe gastrointestinal problems may arise. If any unusual symptoms appear while taking this medication, you should consult a doctor immediately. This medication may negatively affect patients at risk for cardiac conditions such as QT prolongation syndrome or hyperkalemia, so caution is advised. If angioedema or anaphylaxis occurs, you must immediately stop taking the medication and seek appropriate treatment. Drowsiness, blurred vision, and fatigue may occur when driving or operating machinery, so precautions are needed. Taking this medication in conjunction with certain anticholinergic drugs may enhance its effectiveness or exacerbate side effects, and it may reduce the effectiveness of medications that increase gastrointestinal motility. Additionally, since this medication is metabolized by the CYP3A4 enzyme, taking it with strong CYP3A4 inhibitors can increase drug concentration, heightening the risk of side effects. The safety in pregnant women has not been established, so caution is advised during pregnancy, and breastfeeding should be avoided as this medication may excrete into breast milk and harm the newborn. The safety and efficacy in pediatric patients have also not been established, so it is advisable not to use it in children. In the event of an overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and appropriate treatment like activated charcoal or gastric lavage should be obtained as needed. This medication is considered to have a low risk of genetic toxicity or tumor development even with long-term use, and it is known not to affect reproductive capacity or early fetal development.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• dyspepsia
• abdominal pain
• vomiting
• urinary tract infection

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. The recommended storage temperature is between 1°C and 30°C.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets (10 tablets/PTP) x 3