Vesicare^®

Solifenacin Succinate

Solifenacin Succinate 5mg, 10mg

Tablets for oral use

Product leaflet summary

Therapeutic Indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Dosage and Administration

The recommended dose is 5mg Solifenacin succinate once daily. If needed, the dose may be increased to 10 mg Solifenacin succinate once daily.

Safety and effectiveness in children have not yet been established. Therefore, VESICARE should not be used in children.

No dose adjustment is required for patients with mild to moderate renal and mild hepatic impairment, but patients with severe renal and moderate hepatic impairment should be treated with caution and receive not more than 5mg once daily.

A maximum dose of 5 mg should be given along with treatment with Ketoconazole or other potent CYTP3A4.

Contraindications

VESICARE is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including the toxic mega colon), 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 hemodialysis.
• 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.

Pregnancy and Lactation

Pregnancy:

No clinical data are available for women who became pregnant while taking Solifenacin. Caution should be exercised when prescribing to pregnant women.

Lactation:

No data on the excretion of Solifenacin in human milk are available. The use of VESICARE should therefore be avoided during breastfeeding.

Ability to Drive and Use Machinery

Since Solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue, the ability to drive and use machines may be negatively affected.

Package Presentation:

1- A box of 30 tablets each contains 5 mg Solifenacin Succinate.

2- A box of 30 tablets each contains 10 mg Solifenacin Succinate.