Bessisol Tablets 10 mg (Solifenacin Succinate)

Adult dose

The 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 dose 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 dose 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: In 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 symptoms of urinary retention. It should also be avoided in patients with serious gastrointestinal issues, muscle weakness, or those with glaucoma where eye pressure is elevated. Patients with an allergy to this medication or its ingredients, those undergoing dialysis, and patients with severely impaired liver or kidney function should also avoid it. It is advisable to avoid this medication in patients with specific genetic metabolic disorders. Caution is required for patients who may have a risk of urinary blockage or those with gastrointestinal obstruction issues and slower gastrointestinal motility. In cases of severe kidney or liver dysfunction, dosage should be restricted, and caution is needed when used in conjunction with specific powerful medications. Patients with gastroesophageal reflux disease or autonomic nervous system abnormalities should also be cautious. Common side effects of this medication include dry mouth, constipation, blurred vision, dry eyes, nausea, indigestion, upper abdominal pain, vomiting, urinary tract infections, influenza, pharyngitis, dizziness, depression, cough, hypertension, fatigue, difficulty urinating, decreased urine flow, post-void residual, cystitis, rhinitis, headaches, hallucinations, drowsiness, confusion, renal impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, prolonged QT interval on ECG, abnormal liver function tests, and appetite change. Patients with irregular heartbeat or elevated potassium levels in blood should be cautious as there is a risk of cardiac side effects when using this medication. Severe allergic reactions such as vascular edema or anaphylaxis may occur, and if any abnormal symptoms appear, the use of the medication should be stopped immediately and medical treatment sought. Using this medication in combination with other anticholinergic drugs can enhance its effects or increase side effects, therefore caution is needed during co-administration. Additionally, it may reduce the effectiveness of drugs that promote gastrointestinal motility. Safety has not been established for pregnant women, and it should be avoided during breastfeeding as it may affect the baby. Safety and efficacy in children have not been established; therefore, it should not be administered to them. In cases of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and appropriate treatment such as gastric lavage or activated charcoal may be necessary. This medication may take about 4 weeks to reach maximum effect, so consistent use is important. Caution should be taken while driving or operating machinery due to the risk of drowsiness or blurred vision.

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

This medication should be stored in a closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)