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HSA Approval

Vesicare Tablet 10mg

SIN13703P

Vesicare Tablet 10mg

Vesicare Tablet 10mg

September 18, 2009

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantASTELLAS PHARMA SINGAPORE PTE. LTD.
Licence HolderASTELLAS PHARMA SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Solifenacin succinate

10 mg

Solifenacin

Documents

Package Inserts

Vesicare Tablet 10mg PI.pdf

Approved: October 18, 2018

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