CM Care Tablet 5mg (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 required 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 required 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 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 drug is used to control bladder overactivity. However, it should not be used in patients with urinary retention where urine is not easily discharged, severe gastrointestinal issues, myasthenia gravis, and narrow-angle glaucoma. Additionally, individuals allergic to this drug or its ingredients, patients undergoing dialysis, and those with severe liver or kidney dysfunction should not use it. Special caution is needed for patients with moderate to severe liver or kidney function who are taking strong CYP3A4 inhibitors, as well as for those genetically unable to digest certain sugars. This medication should be administered cautiously in patients with bladder outlet obstruction at risk of urinary retention or those with gastrointestinal obstruction and decreased motility. For patients with weakened liver or kidney function, the maximum daily dose must be limited, and dosage adjustments are necessary when used in conjunction with strong CYP3A4 inhibitors. Moreover, patients with gastroesophageal reflux disease, esophagitis, or autonomic neuropathy should also be monitored closely. Common side effects when taking this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly with high doses, serious adverse reactions such as gastrointestinal obstruction may occur, so caution is warranted. Other reported symptoms include dizziness, fatigue, cough, and hypertension. Rarely, serious allergic reactions such as angioedema or anaphylaxis may occur, and if such symptoms arise, the medication should be stopped immediately, and medical attention should be sought. Additionally, caution is advised when driving or operating machinery due to the potential for drowsiness or blurred vision. This medication may increase the effects or severity of side effects when used with other anticholinergic drugs. It may also reduce the effectiveness of drugs that enhance gastrointestinal motility, so caution is advised when combining these drugs. Since this medication is primarily metabolized in the liver, co-administration with strong CYP3A4 inhibitors may increase serum concentrations, requiring dose adjustments. Patients with severely compromised liver or kidney function should avoid using these medications in combination. The safety of this medication during pregnancy has not been established, so pregnant women must consult a doctor before taking it. Breastfeeding mothers should also avoid using it due to the potential for secretion into breast milk. The safety and efficacy of this medication in children have not been established, thus it should not be administered to children. In case of overdose, immediate medical attention should be sought, and appropriate treatment should be administered depending on symptoms. Inducing vomiting should be avoided; activated charcoal can be used. Severe symptoms may require specialized treatment. This medication is known not to significantly increase the risk of genotoxicity or tumor development even with long-term use. However, if any unusual symptoms occur while taking this medication, it is crucial to consult a healthcare professional for appropriate action.

• 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 prevent air and moisture infiltration. It is best kept at room temperature between 1°C and 30°C.

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle