Solica 5 mg (Solifenacin Succinate)

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. 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 a strong cytochrome P450 3A4 (CYP3A4) inhibitor For 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 severe gastrointestinal diseases such as toxic megacolon. Additionally, it should not be administered to patients with myasthenia gravis, narrow-angle glaucoma, or those allergic to this medication or its components. It should also be avoided in patients undergoing hemodialysis or those with severe liver or kidney impairment taking potent CYP3A4 inhibitors. Patients with hereditary galactose intolerance or lactase deficiency should also refrain from using this medication. Patients at risk for urinary retention, bladder outlet obstruction, gastrointestinal obstructive diseases, or decreased gastrointestinal motility should use this medication with caution. In patients with severe renal impairment or moderate liver impairment, the maximum daily dose should be restricted to 5 mg, and caution is advisable when used in conjunction with potent CYP3A4 inhibitors. This medication should also be used cautiously in patients with gastroesophageal reflux disease, esophagitis, or autonomic neuropathy. The most commonly reported side effects when taking this medication are dry mouth and constipation. Symptoms such as blurred vision, urinary retention, and dry eyes may also occur, and serious gastrointestinal side effects may arise if high doses are used. If angioedema or allergic reactions occur, discontinue the drug immediately and seek appropriate treatment. This drug can affect heart rhythm, so care is required in patients with long QT syndrome or hyperkalemia. Drowsiness or fatigue may occur when driving or operating machinery, requiring caution. When taken with other anticholinergic medications, the effects may be enhanced, or side effects may increase, so caution is necessary when coadministering. Moreover, this drug is metabolized by the CYP3A4 enzyme, so taking it with potent CYP3A4 inhibitors can lead to increased drug concentrations, necessitating dose adjustments. The safety for pregnant women has not been established; therefore, pregnant women should be cautious when taking this medication, and nursing mothers are advised to avoid its use. The safety and efficacy in children have not been established, so this medication should not be administered to children. In the event of an overdose, symptoms may include headache, thirst, dizziness, drowsiness, and blurred vision. If severe symptoms arise, appropriate emergency treatment is needed. Before taking this medication, consult with a doctor or pharmacist to inform them of your health condition and any other medications you are taking.

• 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 closed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow, round, film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)