Selperina Tablet 5 mg (Solifenacin Succinate)

Adult dose

The usual 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 dose 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 dose 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors: In patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication is an agent to control bladder hyperactivity and should not be used in individuals with specific health conditions. For example, it should not be taken by individuals with urinary retention, severe gastrointestinal diseases, muscle weakness, glaucoma, patients undergoing hemodialysis, or individuals with severely impaired liver or kidney function. Additionally, it should be avoided by those who are allergic to this medication. Caution should be exercised when using this medication if there is a risk of obstruction of the bladder outlet or gastrointestinal obstruction, moderate liver and kidney dysfunction, or when taken with specific antifungal or antiviral agents. Additionally, those with gastroesophageal reflux or esophagitis and problems with autonomic nervous system should use with caution. This medication may cause dry mouth, constipation, blurred vision, and occasionally urinary retention. Particularly, there may be serious gastrointestinal issues when taken in high doses. Caution is also advised when driving or operating machinery, as drowsiness and blurred vision may increase the risk of accidents. Taking this medication with other anticholinergic drugs may enhance its effects or worsen side effects; caution should be exercised when taken in combination. Furthermore, it may reduce the effectiveness of medications that promote gastrointestinal motility. This medication is metabolized by specific enzymes (CYP3A4) in the liver, so dosage adjustments may be necessary when taken with drugs that strongly inhibit this enzyme. Patients with severely impaired liver or kidney function should avoid co-administration with such drugs. Safety during pregnancy has not been established; therefore, careful consideration is needed when taking it during this period. Also, nursing mothers are advised to avoid it as it may be transmitted through breast milk. Safety and efficacy in children have not been confirmed, and it should not be used in this population. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may appear, and immediate medical attention should be sought for appropriate treatment. During use of this medication, individuals with heart-related diseases or electrolyte imbalances should exercise caution, as severe allergic reactions or angioedema may occur rarely. If any abnormal symptoms arise, discontinue the medication immediately and consult a healthcare professional.

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

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is advised to maintain storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright yellow, round film-coated tablet

Package unit

100 tablets (10 tablets/ PTP X 10)