Vesicare 10 mg 30 tablets

Available at Pharmaegy Pharmacy. Use as directed by your doctor.

Vesicare 10 mg film-coated tablets Composition: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. Description: The active substance of Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. Vesicare is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time. Indications: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Dosage and method of administration: Adults, including the elderly: The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. Paediatric population: The safety and efficacy of Vesicare in children have not yet been established. Therefore, Vesicare should not be used in children. Patients with renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily. Patients with hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily. Method of administration: Vesicare should be taken orally and should be swallowed whole with liquids. It can be taken with or without food. Contraindications: Solifenacin is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. - Patients hypersensitive to the active substance or to any of the excipients. - Patients undergoing haemodialysis. - Patients with severe hepatic impairment. - Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole Precautions: Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Vesicare. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Vesicare should be used with caution in patients with: - clinically significant bladder outflow obstruction at risk of urinary retention. - gastrointestinal obstructive disorders. - risk of decreased gastrointestinal motility. - severe renal impairment (creatinine clearance ≤ 30 ml/min; and doses should not exceed 5 mg for these patients. - moderate hepatic impairment (Child-Pugh score of 7 to 9), and doses should not exceed 5 mg for these patients. - concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole. - hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis. - autonomic neuropathy. -Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. -Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. -Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. -The maximum effect of Vesicare can be determined after 4 weeks at the earliest. Pregnancy: The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women. Breast-feeding The use of Vesicare should be avoided during breast-feeding. Side Effects: Common: Dry mouth Blurred vision Constipation Nausea Dyspepsia Abdominal pain Uncommon: Urinary tract infection Cystitis Somnolence Dysgeusia Dry eyes Nasal dryness Gastro-oesophageal reflux diseases Dry throat Dry skin Difficulty in micturition Fatigue Peripheral oedema Storage Method: Store at a temperature not exceeding 30C Package: A carton box contains 3 blisters 10 tablets each and an insert leaflet.