Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** _Adults, including the elderly_ The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg solifenacin succinate once daily. _Children and adolescents_ Solifenacin succinate is not indicated for treatment of OAB in the pediatric population. **Special populations** _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 B) should be treated with caution and receive no more than 5 mg once daily. Vesicare is not recommended for patients with severe hepatic impairment (Child-Pugh C). _Co-medication_ The maximum dose of Vesicare should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide antibiotics (see also INTERACTIONS WITH OTHER DRUGS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** Vesicare should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
ORAL
Medical Information
**INDICATIONS** Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
**CONTRAINDICATIONS** Solifenacin is contraindicated in - patients with urinary retention - patients with uncontrolled narrow-angle glaucoma - patients who have demonstrated hypersensitivity to the drug substance or other components of the product - severe gastro-intestinal condition (including toxic megacolon and gastric retention) - myasthenia gravis - 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
G04BD08
solifenacin
Manufacturer Information
ASTELLAS PHARMA SINGAPORE PTE. LTD.
Astellas Pharma Europe B.V.
Active Ingredients
Documents
Package Inserts
Vesicare Tablet 10mg PI.pdf
Approved: October 18, 2018