Acare S Tablets 5 mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken without regard to meals 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 for 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 for 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors Limit the maximum daily dose to 5mg in patients taking ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

This medication should not be used in patients with certain conditions. For example, it should not be administered to those with urinary retention symptoms, severe gastrointestinal issues, myasthenia gravis, glaucoma, those allergic to any of the components, patients undergoing dialysis, or those with severe liver or kidney dysfunction. In addition, caution is required for patients with specific diseases or those taking other medications. For example, patients at risk of bladder outlet obstruction, those with gastrointestinal obstruction, severe kidney or liver dysfunction, and patients taking certain antifungal or other medications may need dosage adjustments or special attention. Side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, nausea, dyspepsia, upper abdominal pain, vomiting, flu-like symptoms, pharyngitis, dizziness, depression, lower extremity edema, fatigue, cough, high blood pressure, difficulty urinating, reduced urine flow, bladder fullness, cystitis, nasopharyngitis, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, kidney disorders, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, and QT prolongation on ECG may occur when taking this medication. Particularly, higher doses may increase the frequency of these symptoms. Rarely, angioedema or anaphylaxis (severe allergic reactions) may occur, and if these symptoms arise, it is essential to stop taking the medication immediately and inform a healthcare professional. This medication may require caution while driving or operating machinery, as drowsiness, blurred vision, and fatigue may occur in rare cases. Taking this medication with other anticholinergic drugs may enhance its effect or increase side effects, so consultation with a healthcare provider is necessary. It may also reduce the effect of gastrointestinal motility-enhancing drugs. This medication is metabolized by specific enzymes (CYP3A4) in the liver, so taking it with drugs that strongly inhibit this enzyme can increase the blood concentration of this medication, raising the risk of side effects. Therefore, when taking such medications, dosage adjustments should be made. The safety of this medication for pregnant women has not been sufficiently established, so use should be cautious if pregnant or potentially pregnant. Breastfeeding women are advised not to use this medication, as it may be excreted in breast milk and affect infants. The safety and efficacy of this medication in children have not been established, thus it should not be used in this population. In case of overdose, it is crucial to visit a medical institution immediately for appropriate treatment, and inducing vomiting is not recommended. Symptoms due to overdose may include central nervous system symptoms, cardiac issues, and difficulty in urination.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• nausea
• indigestion
• upper abdominal pain
• vomiting
• urinary tract infection

This medication should be stored in a sealed container to prevent exposure to air and moisture, at a temperature between 1°C to 30°C. Storing it this way helps maintain the medication's efficacy.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP*10]