Detrunorm 15 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propiverine hydrochloride

Available from:

Apogepha Arzneimittel GmbH

ATC code:

G04BD; G04BD06

INN (International Name):

Propiverine hydrochloride

Dosage:

15 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence; propiverine

Authorization status:

Not marketed

Authorization date:

2008-12-12

Summary of Product characteristics

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