Beside Tablet 5 mg (Solifenacin Succinate)

Adult dose

For adults (including older adults), the usual recommended dose 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. Dose adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in 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 in 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors Limit the maximum daily dose to 5mg in patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

This medication should not be used in patients with urinary retention, severe gastrointestinal disorders such as toxic megacolon, severe myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to patients who are allergic to this medication or its components, patients undergoing hemodialysis, or those with severe liver or kidney dysfunction. This medication is also unsuitable for patients with genetically determined galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Caution is required when administering to patients with bladder outlet obstruction at risk of urinary retention or those with obstructive gastrointestinal disorders, or patients at risk of reduced gastrointestinal motility. Patients with moderate to severe reduced liver or kidney function, or those taking strong CYP3A4 inhibitors also require caution. Additionally, patients taking medications that may exacerbate gastroesophageal reflux or esophagitis, as well as patients with autonomic neuropathy should use this medication with care. This medication may cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Notably, dry mouth and constipation are common and the incidence of side effects may increase with high-dose usage. There have been rare reports of angioedema, intestinal obstruction, and severe allergic reactions, thus immediate consultation with healthcare professionals is necessary if unusual symptoms occur. Caution is needed in patients with QT prolongation syndrome or hyperkalemia as they may have an increased risk of cardiac arrhythmias. If severe allergic reactions such as angioedema or anaphylaxis occur, discontinue the medication immediately and receive appropriate treatment. This medication may cause drowsiness or blurred vision, so caution is required when driving or operating machinery. When taken with anticholinergic medications, the effects may be enhanced or side effects may worsen, and there may be interactions with medications that increase gastrointestinal motility. This medication is primarily metabolized by CYP3A4, thus concomitant use with strong CYP3A4 inhibitors may increase the blood concentration of this medication, necessitating dosage adjustments. The safety of this medication during pregnancy has not been established, so caution is advised when administering to pregnant women, and usage should be avoided during breastfeeding as there is a possibility of excretion into breast milk. The safety and effectiveness in children have not been established, so this medication should not be administered to children. In case of overdose, appropriate treatment such as activated charcoal administration is necessary, and professional treatment is required if severe central nervous system symptoms or cardiac abnormalities are present.

Dry mouth, constipation, blurred vision, urinary retention, dry eyes, nausea, indigestion, epigastric pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, lower leg swelling, fatigue, cough, hypertension, angioedema, fecal impaction, colon obstruction, intestinal obstruction, vascular edema, anaphylactic reaction, vomiting, gastroesophageal reflux disease, bowel obstruction, peripheral edema, headache, hallucinations, drowsiness, delirium, kidney impairment, itching, rash, hives, angioedema, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, polymorphic ventricular tachycardia, QT prolongation on electrocardiogram, abnormal liver function tests, decreased appetite, hyperkalemia, speech disorders, glaucoma, muscle weakness, dysuria, decreased urine flow, post-void residual, cystitis, rhinitis, increased serum creatinine, perforated duodenal ulcer, urinary retention, acute renal failure, bladder neck obstruction, exacerbation of renal function impairment, pneumonia, elevated prostate-specific antigen, ovarian carcinoma, bile duct cancer, uterine cancer, myocardial infarction, decreased cardiac output, soft tissue infection, increased urinary frequency, urinary disorders, urgency incontinence, neurogenic bladder, skin tingling, generalized edema, male perineal pain, insomnia, anxiety, decreased libido, back pain, vaginal bleeding, syncope, hearing impairment, keratosis, hair loss, feeling of heaviness, erectile dysfunction, abnormal orgasm, retrograde ejaculation, blood-tinged urine, chest tightness, chest pain, periorbital edema, edema, benign prostatic hyperplasia, male genital itching, decreased erection, thirst, headache, dry mouth, drowsiness

This medication should be stored in a tightly sealed container to protect it from air and moisture. The optimal storage temperature is between 1 degrees and 30 degrees Celsius at room temperature.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/ PT packaging x 10), 30 tablets/bottle, 100 tablets/bottle