Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Propiverine hydrochloride
Apogepha Arzneimittel GmbH
G04BD; G04BD06
Propiverine hydrochloride
15 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Drugs for urinary frequency and incontinence; propiverine
Not marketed
2008-12-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrunorm 15 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg propiverine hydrochloride (equivalent to 13.64 mg propiverine). Excipients with known effect: Lactose monohydrate (100.7 mg). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets White, biconvex, round film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries, e.g. transverse lesion paraplegia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Film-coated tablets for oral use. The recommended daily doses are as follows: Adults: As a standard dose one film-coated tablet (= 15 mg propiverine hydrochloride) twice daily is recommended, this may be increased to three times daily. Some patients may already respond to a dosage of 15 mg daily. For neurogenic detrusor overactivity a dose of one film-coated tablet three times daily is recommended. The maximum recommended daily dose is 45 mg. Elderly: Generally there is no special dosage regimen for the elderly (see section 5.2). Paediatric population: Due to a lack of data Detrunorm should not be used in children. Caution should be exercised and physicians should monitor patients carefully for side effects in the following dispositions (see sections 4.4, 4.5, 5.2): Use in renal impairment In patients with mild or moderate impairment of renal function, no dose adjustment is required; however, they should be treated with caution. In patients with severely impaired renal function (creatinine clearance < 30 ml/min), the maximum daily dose is 30 mg. Use in hepatic impairment In patients with mildly impaired hepatic function, there is no need for dose adjustment; however, treatment should proceed with caution. No studies Прочитать полный документ