Vesicare Tablet 10mg

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

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.