Trade Name: 
Mictoryl; Mictoryl Pediatric
Duchesnay Inc.
Anticholinergic and antispasmodic agent
ATC Class: 
G04BD06 - urinary antispasmodics
Notice of Compliance (yyyy/mm/dd): 
Date Marketed in Canada (yyyy/mm/dd): 
Tablet: 5 mg. DIN: 02460289
Capsule: 30 mg. DIN: 02460262
Capsule: 45 mg. DIN: 02460270
Duchesnay is marketing propiverine for the treatment of overactive bladder. The pediatric tablets contain 5 mg while the adult modified-release capsules contain 30 mg and 45 mg. The 5 mg dose can be used in children 5 years of age and older up to a maximum body weight of 35 kg. In children and adolescents with a body weight over 35 kg, the maximum recommended dose is 30 mg administered in two daily doses. There is only limited efficacy and safety data on children and adolescents of higher body weight (≥35 kg) receiving daily dose of 30 mg propiverine. The 30 mg and 45 mg preparation may be used in adults, including the geriatric population. The recommended dose is one capsule containing 30 mg propiverine hydrochloride once daily. If the dose is well tolerated and clinical effect is not improved adequately, the dose may be increased to 45 mg propiverine hydrochloride.