Hyundai Solifenacin Succinate Tablets 5mg

Adult dose

The usual recommended dose for adults (including the elderly) 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. Dose adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4(CYP3A4) inhibitors For patients taking 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 certain diseases or conditions. For example, it should not be administered to patients with urinary retention symptoms where urination is difficult, those with severe gastrointestinal problems, patients with myasthenia gravis, and certain glaucoma patients. Additionally, patients who have had hypersensitivity reactions to this medication, those undergoing hemodialysis, and patients with severe liver or kidney dysfunction should not use this medication. Patients with certain genetic metabolic abnormalities are also excluded from treatment. Caution should be exercised when using this medication in some patients. For instance, it should be used carefully in patients with a risk of narrow or obstructed urinary tracts, those at risk of gastrointestinal obstruction or reduced motility, patients with severe renal dysfunction, and those with moderate liver dysfunction; dosage adjustments or cautious administration may be required in cases of co-administration with specific drugs. Common side effects that may occur while using this medication include dry mouth and constipation, as well as blurred vision or dry eyes. Rarely, it may result in difficulty urinating or severe gastrointestinal issues. This medication can cause severe allergic reactions such as arrhythmias, angioedema, and anaphylaxis, so if these symptoms occur, drug use should be immediately discontinued and medical attention sought. Moreover, this medication may affect the ability to drive or operate machinery, so caution is required. When used in conjunction with other anticholinergic drugs, this medication's effectiveness may increase, or its side effects may intensify, and it can diminish the efficacy of prokinetic agents. This medication is metabolized by certain enzymes (CYP3A4) in the liver, so co-administration with drugs that strongly inhibit this enzyme could lead to increased levels of this medication and consequently a higher risk of side effects. Therefore, dosage adjustments may be necessary when co-administering such medications. Safety in pregnant women has not been established, so it should be used cautiously during pregnancy. It is advisable for nursing women to avoid using this medication. Safety and efficacy in children have not been established, so it should not be administered to them. In cases of overdose, inducing vomiting should be avoided, and appropriate treatment such as activated charcoal is necessary, with professional treatment required depending on the severity of symptoms. This medication is known not to have genotoxicity or a risk of tumorigenesis, and does not negatively affect reproductive ability.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, under room temperature conditions between 1°C and 30°C. This storage method helps maintain the medication's effectiveness and prevents degradation.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/PTP [10 tablets/PTP X 10]