Olfenasin 5 mg Tablets (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 dosage 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), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors In patients receiving ketoconazole or another potent 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, severe gastrointestinal diseases, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should also not be administered to patients with hypersensitivity to this medication or its components, patients undergoing hemodialysis, or those with severe liver or kidney impairment. Caution is advised for patients at risk of urinary retention or with gastrointestinal obstructive diseases and reduced gastrointestinal motility. Dose limitation is necessary for patients with severe kidney impairment, moderate liver impairment, or those taking strong CYP3A4 inhibitors. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur when taking this medication. Especially, dry mouth and constipation are reported more frequently with higher doses. Serious allergic reactions such as angioedema or anaphylaxis may occur, so if such symptoms arise, discontinue the medication immediately and seek treatment. This medication requires caution during driving or operating machinery due to drowsiness or blurred vision. The effect may be enhanced or side effects may worsen when used with other anticholinergic medications. Since this drug is metabolized by the CYP3A4 enzyme, dosage adjustment is necessary when used in conjunction with strong CYP3A4 inhibitors. Pregnant women or nursing mothers should use this medication with caution, and particularly avoid its use during breastfeeding. The safety and efficacy in pediatric use have not been established, so administering this medication to children is not recommended. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, requiring appropriate treatment. Patients with a history of heart disease or those at risk of QT prolongation should be especially cautious of overdose.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle