Olpenazine Tablets 10 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 drug 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 required for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). For 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 required for patients with mild hepatic impairment. For 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 For 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 disease, myasthenia gravis, angle-closure glaucoma, hypersensitivity to this drug or its ingredients, patients undergoing hemodialysis, severe liver impairment (Child-Pugh grade C), severe kidney impairment, or patients with moderate liver impairment who are using strong CYP3A4 inhibitors. It should be used with caution in patients at risk of urinary retention, those with gastrointestinal obstructive diseases, at risk of decreased gastrointestinal motility, patients with severe kidney impairment (creatinine clearance ≤30ml/min) or moderate liver impairment, patients receiving strong CYP3A4 inhibitors, those with gastroesophageal reflux or esophagitis, and patients with autonomic neuropathy, and dosage adjustments may be necessary. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with a higher incidence of these side effects noted at high doses. Serious gastrointestinal adverse reactions have also been reported rarely, so caution is needed. This medication may cause cardiac rhythm disorders in patients with QT prolongation syndrome or hyperkalemia, and severe allergic reactions, such as angioedema or anaphylaxis, may occur; if these symptoms arise, treatment should be stopped immediately and appropriate medical care sought. Caution is advised when driving or operating machinery as blurred vision, drowsiness, and fatigue may occur rarely. When used with other anticholinergic medications, efficacy may be enhanced or side effects may increase, and it may diminish the effectiveness of gastrointestinal motility agents. This medication is metabolized by the CYP3A4 enzyme, so when used with strong CYP3A4 inhibitors, blood concentrations may increase, leading to a higher risk of side effects, necessitating dosage adjustments. The safety of this medication during pregnancy has not been established, so it should be used with caution in pregnant women, and use during breastfeeding should be avoided due to the possibility of excretion into breast milk and potential harm to the infant. Safety and efficacy in pediatric patients have not been established, so it should not be administered to children. In case of overdose, symptoms may include headache, thirst, dizziness, drowsiness, and blurred vision; appropriate detoxification treatment is necessary in the event of severe symptoms.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store the medicine at room temperature between 1 and 30 degrees Celsius.

Appearance

Light pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP*10)