Besit 10mg (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 drug should not be used in patients with urinary retention where urine does not easily pass. Patients with toxic megacolon or severe gastrointestinal diseases should also not take this medication. It should not be administered to patients with myasthenia gravis where muscle weakness is present. It is contraindicated for patients with angle-closure glaucoma due to increased intraocular pressure. Patients who have an allergic reaction to this drug or any of its ingredients should not take it. Patients on hemodialysis should not use this medication. It should not be taken by patients with severe liver dysfunction, especially those classified as Child-Pugh grade C. Taking this medication with strong CYP3A4 inhibitors could be risky for patients with severely reduced kidney function or moderate to severely impaired liver function. Patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication because it contains lactose. Care should be taken when this medication is used in patients at risk for urinary retention or in those obstructed at the bladder outlet, patients with gastrointestinal obstructive disease, or patients at risk of reduced gastrointestinal motility. Patients with severely compromised kidney function or moderate to severely impaired liver function should limit the maximum daily dose to 5mg. Dosing restrictions are also needed for patients on strong CYP3A4 inhibitors. Patients with gastroesophageal reflux disease or esophagitis, as well as autonomic neuropathy, also require caution. Taking this medication may result in dry mouth or constipation, and it can cause dry eyes and blurred vision. Rarely, symptoms of urinary retention where urine does not easily pass may occur. Severe gastrointestinal side effects such as bowel obstruction can occur, so immediate consultation with a doctor is necessary if any unusual symptoms arise while taking this medication. Dizziness, fatigue, cough, and hypertension have also been reported as side effects. This medication may affect heart rhythms, so caution is required in patients with QT prolongation syndrome or hyperkalemia. Serious allergic reactions may occur, such as angioedema or anaphylaxis, and if these symptoms occur, the drug should be discontinued immediately, and treatment should be sought. Before taking this medication, other causes of frequent urination should be thoroughly investigated, and if a urinary tract infection is present, it should be treated. Care should be taken when driving or operating machinery due to potential drowsiness or blurred vision, as it increases the risk of accidents. Taking this medication with other anticholinergic drugs may enhance effects or increase side effects, so it should be discussed with a physician. This medication can reduce the effects of some drugs that promote gastrointestinal motility. Taking it with strong CYP3A4 inhibitors may increase its blood concentration, raising the risk of side effects, so dose adjustments are necessary. The safety in pregnant women is not definitively established, so it should be used cautiously during pregnancy. Breastfeeding women should avoid this medication as it can pass into breast milk and may be harmful to the baby. Safety and efficacy have not been confirmed for use in children, so it should not be used in pediatric patients. If an overdose occurs, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may appear, and in such cases, immediate contact with a medical institution for proper treatment is necessary. Activated charcoal or other emergency treatments may be required for overdose. This medication is known to pose no risk of genotoxicity or tumorigenesis; however, the precautions mentioned above must always be observed during administration.

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

This medication can be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius in a controlled environment. This helps preserve the drug's efficacy and prevent degradation.

Appearance

Light pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP * 10), 30 tablets/bottle, 100 tablets/bottle